12月13日至10月3日安省疫苗不良反应报告,共737例严重不良反应,10万分之3.4。423例mRNA疫苗心肌炎/心包炎报告,比上周增加15例,233例需要住院。

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
24,722
荣誉分数
6,118
声望点数
373
12月13日至6月5日,总接种将近1千万,共191例严重不良反应,10万分之1.9。其中每十万剂疫苗发生严重不良反应:辉瑞1.3,Moderna: 1.6, AZ:6.9。

191位严重不良反应患者中有187位住院治疗,在提交报告时,59位病人已经康复,91位仍在治疗。

阿斯利康疫苗共发生20例血小板减少症(TTS),2.3 / 10万 = 1 / 43000,其中14例确诊由疫苗诱导的免疫性血小板减少症(VITT),1.6 / 10万 = 1 / 61000, 3例待查,3例确诊与疫苗无关。一例VITT患者死亡报告,死因正在调查,尚未确定。

截止6月5日,安大略省已收到 16 例在接受 COVID19 mRNA 疫苗后出现心肌炎或心包炎的报告。年龄范围在 15 至 78 岁之间(中位数为 33 岁); 3例为 18 岁以下。

共有21人死亡暂时可能与疫苗相关,其中6人是老人院成员。4例死亡与严重不良反应有关,其中3例主要由其他基础病引起,一例为疫苗诱发血小板减少性血栓造成。


Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to June 5, 2021

Highlights

 There are a total of 4,584 AEFI reports received following 9,996,777 doses of COVID-19 vaccines administered in Ontario to date with a reporting rate of 45.9 per 100,000 doses administered (0.05% of all doses administered)
 This represents an increase of 515 AEFI reports compared to previous week
 Of the total 4,584 AEFI reports received to date:
 4,393 AEFI reports are non-serious (95.8% of total AEFI reports)
 191 AEFI reports meet the serious definition (4.2% of total AEFI reports)
 The most commonly reported adverse events are allergic skin reactions and pain/redness/swelling at the injection site, reported in 26.6% and 23.8% of the total AEFI reports respectively
 186 reports of events managed as anaphylaxis are reported, in which 17 reports also meet the serious definition (see Events Managed As Anaphylaxis for more information)
 176 reports include a COVID-19 vaccine-specific adverse event of special interest, in which 84 reports also meet the serious definition (see Adverse events of special interest for more information)
 20 reports of thrombosis with thrombocytopenia syndrome (TTS) after receipt of AstraZeneca/COVISHIELD vaccine, of which 14 are vaccine-induced immune thrombotic thrombocytopenia (VITT) (see TTS/VITT section for more information)

1623297538943.png

1623297550985.png

1623297565308.png
1623338694375.png

Figure 1. Number of AEFI reports and doses administered by week of COVID-19 vaccine administration in Ontario, December 13, 2020 to June 5, 2021
1623297691322.png

Note: AEFI reports are assessed based on date of vaccine administration. The administration week ranges from week 51 (Dec 13 to 19, 2020) to week 22 (May 30 to June 5, 2021). The number of AEFI reports for the recent reporting weeks are subject to reporting delays and/or delayed data entry (i.e., reports are likely to be still under investigation and yet to be reported as a confirmed AEFI report). Data corrections or updates can result in AEFI reports being removed and/or updated from past reports and may result in counts differing from past publicly reported AEFIs.

VACCINE-INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA (VITT) AND THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS)

Thrombosis with Thrombocytopenia Syndrome (TTS) is a condition characterized by the presence of acute venous or arterial thrombosis with new onset thrombocytopenia (low levels of platelets), and no known recent exposure to heparin. A case finding definition proposed by the Brighton Collaboration is being used to support the investigation of this new clinical syndrome by identifying individuals who present with TTS following COVID-19 vaccination. Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) refers to the clinical syndrome of TTS, in addition to laboratory tests that confirm platelet activation (i.e., anti-platelet 4 antibodies). VITT has been reported following immunization with COVID-19 adenoviral vector vaccines, including AstraZeneca/COVISHIELD vaccine.

On May 11, 2021, Ontario announced a pause on the administration of first doses of the AstraZeneca vaccine out of an abundance of caution due to an observed increase in reports of TTS/VITT. However, based on the lag period from vaccination to subsequent symptom onset, clinical recognition and reporting to the vaccine safety surveillance system, there may be additional reports of TTS/VITT reported in the coming weeks.

To date, there have been 20 reports of TTS following the first dose of AstraZeneca/COVISHIELD vaccine in Ontario (including one probable TTS); of these, 14 are confirmed as VITT with positive anti-PF4 antibody test results and three individuals are pending test results. The remaining three TTS events that are not classified as VITT have VITT ruled out through testing (n=2) or did not have confirmatory tests ordered (n=1).

The most recent event had a vaccination date of May 6, 2021. All reports of TTS/VITT to date have occurred after receipt of the first dose of AstraZeneca/COVISHIELD vaccine. There has been one report of death recorded in CCM that has occurred in an individual with VITT. The investigation of this death is ongoing and a cause of death has not been determined at this time.

The following reporting rates are based on the number of first doses of AstraZeneca/COVISHIELD vaccines administered in Ontario as of May 15, 2021 (861,650 doses) as the denominator, which is four days after Ontario’s announcement on the pause of the administration of first doses of the AstraZeneca vaccine. The reporting rate of TTS based on 20 reports is 2.3 per 100,000 first doses administered (approximately 1 in 43,000). The reporting rate of VITT (as a subtype of TTS) based on 14 reports is 1.6 per 100,000 first doses administered (approximately 1 in 62,000).

Reporting rate calculations are subject to changes over time including additional events that are diagnosed and reported to the vaccine safety surveillance system.


MYOCARDITIS/PERICARDITIS

There have been international reports, including from the United States and Israel, of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with COVID-19 mRNA vaccines.9,10 Information to date indicates that these events occur more commonly after the second dose, within several days after vaccination, mainly in adolescents/young adults and more often in males than females.

The Public Health Agency of Canada (PHAC) and Health Canada are closely monitoring these events in passive and active Canadian vaccine safety surveillance systems. In Canada, there have been a small number of reports of myocarditis/pericarditis following vaccination with COVID-19 mRNA vaccines.5 Canada is not currently seeing higher rates than would be expected in the general population.5 At this time, no clear association has been established between myocarditis/pericarditis and mRNA vaccines.

As of June 5, 2021, there have been 16 reports of myocarditis or pericarditis following receipt of COVID19 mRNA vaccines in Ontario. Of these, four were diagnosed with myocarditis and nine were diagnosed with pericarditis, while three were diagnosed with perimyocarditis, myopericarditis or inflammatory cardiac reaction of unclear significance. The age range of the individuals with these events is between 15 and 78 years of age (median 33 years); three events occurred in individuals under 18. The four reports of myocarditis have been assessed using the Brighton Collaboration case definition of myocarditis.11 All four reports met Brighton levels of diagnostic certainty 1 or 2. A Brighton Collaboration case definition for pericarditis is under development and will be applied to Ontario events once available. Ontario is continuing to monitor these events in collaboration with its partners and weekly updates can be found within this report and on the PHAC website.


Serious AEFIs

In Ontario, AEFIs that meet the serious definition are events that required hospital admission and reports of death (see the technical notes for a full definition). There were 191 AEFI reports classified as serious, representing 4.2% of all AEFI reports and a serious AEFI reporting rate of 1.9 per 100,000 doses administered for all vaccine products combined. As a comparison, the proportion of AEFIs defined as serious for all vaccines administered in Ontario ranged from 2.8% and 5.0% between 2012 and 2018.

The serious reporting rate was 1.3 and 1.6 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rates for the AstraZeneca/COVISHIELD vaccine was 6.9 per 100,000 doses administered.


AEFI REPORTS REQUIRING HOSPITALIZATION


187 clients of the 191 serious reports had a hospital admission related to the reported events. Of the 187 clients, 59 had recovered at the time of reporting, 91 were not yet recovered when the investigation was completed but likely to recover, and 19 had an unknown outcome at the time of reporting. Eighteen reports had an outcome reported as “residual effects”, which is defined as residual disability or sequelae related to the reported event. Due to the relatively short follow-up time for AEFIs reported in CCM, it is uncertain whether these residual effects will resolve, but had not yet resolved at the time of reporting.

When a serious report contained multiple adverse events, one event that was the prominent reason for reporting was chosen to describe the serious report. Of the 187 reports of hospitalizations, 76 reported an AESI, 43 reported a medically important event, and seven reported both a medically important event and an AESI (described in the AESI section and the medically important events section). The remaining 61 reports were:

 42 reports of other severe or unusual events
 five reports of severe vomiting/diarrhea
 four reports of arthritis/arthralgia
 three reports of convulsion/seizure
 three reports of anaesthesia/paraesthesia
 one report of paralysis
 one report of Bell’s Palsy
 one report of syncope (fainting) with injury
 one report of cellulitis


AEFI REPORTS WITH FATAL OUTCOME


The remaining four serious AEFIs were reports of death following receipt of COVID-19 vaccine that met the provincial surveillance definition (i.e., other severe/unusual event). One report of death occurred in a resident of a health-care institution with significant co-morbidities. The cause of death was not attributed to the vaccine. The second report of death occurred in a community dwelling senior with complex cardiovascular and renal conditions, wherein the AEFI may have contributed to but was not the underlying cause of death. The third report of death occurred in a community dwelling senior with multiple comorbidities including heart disease and an autoimmune disorder. The cause of death was not attributed to the vaccine. The fourth report of death was recorded in CCM in an individual with VITT (described above under Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) and Thrombosis with Thrombocytopenia Syndrome (TTS)).

Reports of death temporally associated with receipt of vaccine


In Ontario, all deaths temporally associated with receipt of vaccines that have been reported to public health units are thoroughly investigated and reported to PHO. As of June 5, 2021, there are 21 reports of deaths temporally associated with receipt of COVID-19 vaccine that are currently classified as ‘persons under investigation’ as they do not currently meet the provincial surveillance definition. These investigations are ongoing and additional information including a cause of death (e.g., autopsy or Coroner’s report) is expected. Preliminary information suggests that these events occurred in individuals with multiple co-morbidities which may be related to the cause of death. Six of the 21 reports are in long-term care home (LTCH)/retirement home residents. There has been no association with vaccine identified at this time. Reports of death that meet the provincial case definition are events temporally associated with vaccine that have not been clearly attributed to other causes; these reports should not be interpreted as causally related with vaccine.

During the first few months of the COVID-19 vaccination campaign, LTCH/retirement home residents have been a focus for vaccination efforts. In this population, it was expected that deaths may occur close to the time of vaccination and require further evaluation to determine the cause of death. After reviewing reports of deaths of very frail elderly individuals vaccinated with Pfizer-BioNTech COVID-19 vaccine, the Global Advisory Committee on Vaccine Safety (GACVC) COVID-19 Vaccine Safety subcommittee concluded that “the current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of Pfizer-BioNTech COVID-19 vaccine”.13 The Centres for Disease Control (CDC) also presented a similar assessment of their analysis at the January 27, 2021 meeting of the Advisory Committee on Immunization Practices (ACIP) in the United States that mortality in LTCH residents is high and substantial numbers of deaths in this population are expected, unrelated to vaccination.14 PHO continues to conduct continuous monitoring of the safety of COVID-19 vaccines in collaboration with its partners, including individual case review of all serious AEFIs including reports of death temporally association with receipt of vaccine, daily analysis of surveillance data for vaccine safety signals and weekly reporting on the PHO website and to the Public Health Agency of Canada.
 

lindamy

时代广场舞照跳
VIP
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2005-11-23
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12月13日至6月12日,总接种将近1千1百20万,共207例严重不良反应,10万分之1.8。其中每十万剂疫苗发生严重不良反应:辉瑞1.2,Moderna: 1.6, AZ:7.7。

207位严重不良反应患者中有203位住院治疗,在提交报告时,64位病人已经康复,101位仍在治疗。

阿斯利康疫苗共发生21例血小板减少症(TTS),2.4 / 10万 = 1 / 41000,其中16例确诊由疫苗诱导的免疫性血小板减少症(VITT),1.9 / 10万 = 1 / 54000, 5例确诊与疫苗无关。一例VITT患者死亡报告,死因正在调查,尚未确定。

截止6月12日,安大略省已收到 19 例在接受 COVID19 mRNA 疫苗后出现心肌炎或心包炎的报告,14例男性,5例女性。年龄范围在 15 至 78 岁之间(中位数为 32 岁); 4例为 18 岁以下。

共有24人死亡暂时可能与疫苗相关,其中6人是老人院成员。4例死亡与严重不良反应有关,其中3例主要由其他基础病引起,一例为疫苗诱发血小板减少性血栓造成。

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to June 12, 2021

1623901026199.png
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1623901693075.png

1623901703429.png


1623901947311.png
1623902030007.png


Figure 1. Number of AEFI reports and doses administered by week of COVID-19 vaccine administration in Ontario, December 13, 2020 to June 12, 2021
1623902152157.png

Note: AEFI reports are assessed based on date of vaccine administration. The administration week ranges from week 51 (Dec 13 to 19, 2020) to week 23 (June 6 - 12, 2021). The number of AEFI reports for the recent reporting weeks are subject to reporting delays and/or delayed data entry (i.e., reports are likely to be still under investigation and yet to be reported as a confirmed AEFI report). Data corrections or updates can result in AEFI reports being removed and/or updated from past reports and may result in counts differing from past publicly reported AEFIs.

VACCINE-INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA (VITT) AND THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS)

Thrombosis with Thrombocytopenia Syndrome (TTS) is a condition characterized by the presence of acute venous or arterial thrombosis with new onset thrombocytopenia (low levels of platelets), and no known recent exposure to heparin. A case finding definition proposed by the Brighton Collaboration is being used to support the investigation of this new clinical syndrome by identifying individuals who present with TTS following COVID-19 vaccination.7 Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) refers to the clinical syndrome of TTS, in addition to laboratory tests that confirm platelet activation (i.e., anti-platelet 4 antibodies). VITT has been reported following immunization with COVID-19 adenoviral vector vaccines, including AstraZeneca/COVISHIELD vaccine.

On May 11, 2021, Ontario announced a pause on the administration of first doses of the AstraZeneca vaccine out of an abundance of caution due to an observed increase in reports of TTS/VITT. However, based on the lag period from vaccination to subsequent symptom onset, clinical recognition and reporting to the vaccine safety surveillance system, there may be additional reports of TTS/VITT reported in the coming weeks.

To date, there have been 21 reports of TTS following the first dose of AstraZeneca/COVISHIELD vaccine in Ontario (including one probable TTS); of these, 16 are confirmed as VITT with positive anti-PF4 antibody test results. The remaining five TTS events that are not classified as VITT have had VITT ruled out through testing (n=4) or did not have confirmatory tests ordered (n=1). There has also been one report of TTS following a first dose of Moderna vaccine, which is not classified as VITT.

The most recent event following AstraZeneca/COVISHIELD vaccine had a vaccination date of May 6, 2021 and all 21 reports of TTS/VITT associated with AstraZeneca/COVISHIELD vaccine have occurred after receipt of the first dose. There has been one report of death recorded in CCM that has occurred in an individual with VITT. The investigation of this death is ongoing and a cause of death has not been determined at this time.

The following reporting rates are based on the number of first doses of AstraZeneca/COVISHIELD vaccines administered in Ontario as of May 15, 2021 (861,915 doses) as the denominator, which is four days after Ontario’s announcement on the pause of the administration of first doses of the AstraZeneca vaccine. The reporting rate of TTS based on 21 reports is 2.4 per 100,000 first doses administered (approximately 1 in 41,000). The reporting rate of VITT (as a subtype of TTS) based on 16 reports is 1.9 per 100,000 first doses administered (approximately 1 in 54,000). Reporting rate calculations are subject to changes over time including additional events that are diagnosed and reported to the vaccine safety surveillance system.


MYOCARDITIS/PERICARDITIS
There have been international reports, including from the United States and Israel, of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with COVID-19 mRNA vaccines.9,10 Information to date indicates that these events occur more commonly after the second dose, within several days after vaccination, mainly in adolescents/young adults and more often in males than females.


The Public Health Agency of Canada (PHAC) and Health Canada are closely monitoring these events in passive and active Canadian vaccine safety surveillance systems. In Canada, there have been a small number of reports of myocarditis/pericarditis following vaccination with COVID-19 mRNA vaccines.5 Canada is not currently seeing higher rates than would be expected in the general population.5

As of June 12, 2021, there have been 19 reports of myocarditis or pericarditis following receipt of COVID-19 mRNA vaccines in Ontario. Of these, four were diagnosed with myocarditis and twelve were diagnosed with pericarditis, while three were diagnosed with perimyocarditis, myopericarditis or inflammatory cardiac reaction of unclear significance. The four reports of myocarditis have been assessed using the Brighton Collaboration case definition for myocarditis and all four reports met Brighton levels of diagnostic certainty 1 or 2. A Brighton Collaboration case definition for pericarditis is under development and will be applied to Ontario events once available.

Of the 19 reports of myocarditis or pericarditis, 14 were males and 5 were females. The age range of the 19 individuals with these events was between 15 and 78 years of age (median 32 years); four events occurred in individuals under 18 years. None of the four individuals under 18 years of age were hospitalized. Ontario is continuing to monitor these events in collaboration with its partners and weekly updates can be found within this report and on the PHAC website. Please see PHO’s At A Glance: Myocarditis and Pericarditis Following COVID-19 mRNA Vaccines for more information on this topic.1

Serious AEFIs
In Ontario, AEFIs that meet the serious definition are events that required hospital admission and reports of death (see the technical notes for a full definition). There were 207 AEFI reports classified as serious, representing 4.0% of all AEFI reports and a serious AEFI reporting rate of 1.8 per 100,000 doses administered for all vaccine products combined. As a comparison, the proportion of AEFIs defined as serious for all vaccines administered in Ontario ranged from 2.8% and 5.0% between 2012 and 2018.13 The serious reporting rate was 1.2 and 1.6 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rates for the AstraZeneca/COVISHIELD vaccine was 7.7 per 100,000 doses administered.


AEFI REPORTS REQUIRING HOSPITALIZATION

203 clients of the 207 serious reports had a hospital admission related to the reported events. Of the 203 clients, 64 had recovered at the time of reporting, 101 were not yet recovered when the investigation was completed but likely to recover, and 20 had an unknown outcome at the time of reporting. Eighteen reports had an outcome reported as “residual effects”, which is defined as residual disability or sequelae related to the reported event. Due to the relatively short follow-up time for AEFIs reported in CCM, it is uncertain whether these residual effects will resolve, but had not yet resolved at the time of reporting.

When a serious report contained multiple adverse events, one event that was the prominent reason for reporting was chosen to describe the serious report. Of the 203 reports of hospitalizations, 86 reported an AESI, 46 reported a medically important event, and five reported both a medically important event and an AESI (described in the AESI section and the medically important events section). The remaining 66 reports were:

 48 reports of other severe or unusual events
 five reports of severe vomiting/diarrhea
 four reports of arthritis/arthralgia
 three reports of convulsion/seizure
 two reports of anaesthesia/paraesthesia
 one report of paralysis
 one report of Bell’s Palsy
 one report of syncope (fainting) with injury
 one report of cellulitis

AEFI REPORTS WITH FATAL OUTCOME



The remaining four serious AEFIs were reports of death following receipt of COVID-19 vaccine that met the provincial surveillance definition (i.e., other severe/unusual event). One report of death occurred in a resident of a health-care institution with significant co-morbidities. The cause of death was not attributed to the vaccine. The second report of death occurred in a community dwelling senior with complex cardiovascular and renal conditions, wherein the AEFI may have contributed to but was not the underlying cause of death. The third report of death occurred in a community dwelling senior with multiple comorbidities including heart disease and an autoimmune disorder. The cause of death was not attributed to the vaccine. The fourth report of death was recorded in CCM in an individual with VITT

(described above under Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) and Thrombosis with Thrombocytopenia Syndrome (TTS)).


Reports of death temporally associated with receipt of vaccine
In Ontario, all deaths temporally associated with receipt of vaccines that have been reported to public health units are thoroughly investigated and reported to PHO. As of June 12, 2021, there are 24 reports of deaths temporally associated with receipt of COVID-19 vaccine that are currently classified as ‘persons under investigation’ as they do not currently meet the provincial surveillance definition. These investigations are ongoing and additional information including a cause of death (e.g., autopsy or Coroner’s report) is expected. Preliminary information suggests that these events occurred in individuals with multiple co-morbidities which may be related to the cause of death. Six of the 24 reports are in long-term care home (LTCH)/retirement home residents. There has been no association with vaccine identified at this time. Reports of death that meet the provincial case definition are events temporally associated with vaccine that have not been clearly attributed to other causes; these reports should not be interpreted as causally related with vaccine.


During the first few months of the COVID-19 vaccination campaign, LTCH/retirement home residents have been a focus for vaccination efforts. In this population, it was expected that deaths may occur close to the time of vaccination and require further evaluation to determine the cause of death. After reviewing reports of deaths of very frail elderly individuals vaccinated with Pfizer-BioNTech COVID-19 vaccine, the Global Advisory Committee on Vaccine Safety (GACVC) COVID-19 Vaccine Safety subcommittee concluded that “the current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of Pfizer-BioNTech COVID-19 vaccine”.14 The Centres for Disease Control (CDC) also presented a similar assessment of their analysis at the January 27, 2021 meeting of the Advisory Committee on Immunization Practices (ACIP) in the United States that mortality in LTCH residents is high and substantial numbers of deaths in this population are expected, unrelated to vaccination.15 PHO continues to conduct continuous monitoring of the safety of COVID-19 vaccines in collaboration with its partners, including individual case review of all serious AEFIs including reports of death temporally association with receipt of vaccine, daily analysis of surveillance data for vaccine safety signals and weekly reporting on the PHO website and to the Public Health Agency of Canada.
 
最后编辑:
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2014-02-10
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93
所在地
Ottawa

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
24,722
荣誉分数
6,118
声望点数
373
12月13日至6月19日,总接种将近12.55 millions,共225例严重不良反应,10万分之1.8。其中每十万剂疫苗发生严重不良反应:辉瑞1.2,Moderna: 1.6, AZ:7.7。

225位严重不良反应患者中有203位住院治疗,在提交报告时,64位病人已经康复,101位仍在治疗。

阿斯利康疫苗共发生21例血小板减少症(TTS),2.4 / 10万 = 1 / 41000,其中16例确诊由疫苗诱导的免疫性血小板减少症(VITT),1.9 / 10万 = 1 / 54000, 5例确诊与疫苗无关。一例VITT患者死亡报告,死因正在调查,尚未确定。

截止6月19日,安大略省已收到 26 例在接受 COVID19 mRNA 疫苗后出现心肌炎或心包炎的报告,19例男性,7例女性。年龄范围在 15 至 78 岁之间(中位数为 27 岁); 6例为 18 岁以下。

共有28人死亡暂时可能与疫苗相关,其中5人是老人院成员。4例死亡与严重不良反应有关,其中3例主要由其他基础病引起,一例为疫苗诱发血小板减少性血栓造成。

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to June 19, 2021

1624502166491.png
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1624502717314.png
1624502726387.png


1624503623475.png
1624503602306.png


Figure 1. Number of AEFI reports and doses administered by week of COVID-19 vaccine administration in Ontario, December 13, 2020 to June 19, 2021
1624503801474.png


Note: AEFI reports are assessed based on date of vaccine administration. The administration week ranges from week 51 (Dec 13 to 19, 2020) to week 24 (June 13 - 19, 2021). The number of AEFI reports for the recent reporting weeks are subject to reporting delays and/or delayed data entry (i.e., reports are likely to be still under investigation and yet to be reported as a confirmed AEFI report). Data corrections or updates can result in AEFI reports being removed and/or updated from past reports and may result in counts differing from past publicly reported AEFIs.

VACCINE-INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA (VITT) AND THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS)

Thrombosis with Thrombocytopenia Syndrome (TTS) is a condition characterized by the presence of acute venous or arterial thrombosis with new onset thrombocytopenia (low levels of platelets), and no known recent exposure to heparin.7 A case finding definition proposed by the Brighton Collaboration is being used to support the investigation of this new clinical syndrome by identifying individuals who present with TTS following COVID-19 vaccination.7 Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) refers to the clinical syndrome of TTS, in addition to laboratory tests that confirm platelet activation (i.e., anti-platelet 4 antibodies). VITT has been reported following immunization with COVID-19 adenoviral vector vaccines, including AstraZeneca/COVISHIELD vaccine.

On May 11, 2021, Ontario announced a pause on the administration of first doses of the AstraZeneca vaccine out of an abundance of caution due to an observed increase in reports of TTS/VITT. However, based on the lag period from vaccination to subsequent symptom onset, clinical recognition and reporting to the vaccine safety surveillance system, there may be additional reports of TTS/VITT reported in the coming weeks.

To date, there have been 21 reports of TTS following the first dose of AstraZeneca/COVISHIELD vaccine in Ontario (including one probable TTS); of these, 16 are confirmed as VITT with positive anti-PF4 antibody test results. The remaining five TTS events that are not classified as VITT have had VITT ruled out through testing (n=4) or did not have confirmatory tests ordered (n=1). There has also been one report of TTS following a first dose of Moderna vaccine, which is not classified as VITT.

The most recent event following AstraZeneca/COVISHIELD vaccine had a vaccination date of May 6, 2021 and all 21 reports of TTS/VITT associated with AstraZeneca/COVISHIELD vaccine have occurred after receipt of the first dose. There has been one report of death recorded in CCM that has occurred in an individual with VITT. The investigation of this death is ongoing and a cause of death has not been determined at this time.

The following reporting rates are based on the number of first doses of AstraZeneca/COVISHIELD vaccines administered in Ontario as of May 15, 2021 (862,640 doses) as the denominator, which is four days after Ontario’s announcement on the pause of the administration of first doses of the AstraZeneca vaccine. The reporting rate of TTS based on 21 reports is 2.4 per 100,000 first doses administered (approximately 1 in 41,000). The reporting rate of VITT (as a subtype of TTS) based on 16 reports is 1.9 per 100,000 first doses administered (approximately 1 in 54,000). Reporting rate calculations are subject to changes over time including additional events that are diagnosed and reported to the vaccine safety surveillance system.

MYOCARDITIS/PERICARDITIS

There have been international reports, including from the United States and Israel, of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with COVID-19 mRNA vaccines.9,10 Information to date indicates that these events occur more commonly after the second dose, within several days after vaccination, mainly in adolescents/young adults and more often in males than females.

The Public Health Agency of Canada (PHAC) and Health Canada are closely monitoring these events in passive and active Canadian vaccine safety surveillance systems. In Canada, there have been a small number of reports of myocarditis/pericarditis following vaccination with COVID-19 mRNA vaccines.5 Canada is not currently seeing higher rates than would be expected in the general population.

As of June 19, 2021, there have been 26 reports of myocarditis or pericarditis following receipt of COVID-19 mRNA vaccines in Ontario. Of these, five were diagnosed with myocarditis and 14 were diagnosed with pericarditis. The remaining seven were diagnosed with perimyocarditis (n=1), myopericarditis (n=5) or inflammatory cardiac reaction of unclear significance (n=1). The five reports of myocarditis have been assessed using the Brighton Collaboration case definition for myocarditis; four reports met Brighton levels of diagnostic certainty 1 or 2 and one report had insufficient evidence to meet level 1, 2 or 3 of the case definition. 11 A Brighton Collaboration case definition for pericarditis is under development and will be applied to Ontario events once available.

Of the 26 reports of myocarditis or pericarditis, 19 were males and seven were females. The age range of the 26 individuals with these events was between 15 and 78 years of age (median 27 years); six events occurred in individuals under 18 years. One individual under 18 years of age was hospitalized. Ontario is continuing to monitor these events in collaboration with its partners and weekly updates can be found within this report and on the PHAC website. Please see PHO’s At A Glance: Myocarditis and Pericarditis Following COVID-19 mRNA Vaccines for more information on this topic.12

Serious AEFIs

In Ontario, AEFIs that meet the serious definition are events that required hospital admission and reports of death (see the technical notes for a full definition). There were 225 AEFI reports classified as serious, representing 4.0% of all AEFI reports and a serious AEFI reporting rate of 1.8 per 100,000 doses administered for all vaccine products combined. As a comparison, the proportion of AEFIs defined as serious for all vaccines administered in Ontario ranged from 2.8% and 5.0% between 2012 and 2018.13 The serious reporting rate was 1.2 and 1.6 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rates for the AstraZeneca/COVISHIELD vaccine was 7.7 per 100,000 doses administered.

AEFI REPORTS REQUIRING HOSPITALIZATION

221 clients of the 225 serious reports had a hospital admission related to the reported events. Of the 221 clients, 71 had recovered at the time of reporting, 110 were not yet recovered when the investigation was completed but likely to recover, and 20 had an unknown outcome at the time of reporting. Twenty reports had an outcome reported as “residual effects”, which is defined as residual disability or sequelae related to the reported event. Due to the relatively short follow-up time for AEFIs reported in CCM, it is uncertain whether these residual effects will resolve, but had not yet resolved at the time of reporting.

When a serious report contained multiple adverse events, one event that was the prominent reason for reporting was chosen to describe the serious report. Of the 221 reports of hospitalizations, 92 reported an AESI, 50 reported a medically important event, and five reported both a medically important event and an AESI (described in the AESI section and the medically important events section). The remaining 74 reports were:

 53 reports of other severe or unusual events
 six reports of severe vomiting/diarrhea
 five reports of convulsion/seizure
 four reports of arthritis/arthralgia
 two reports of anaesthesia/paraesthesia
 one report of paralysis  one report of Bell’s Palsy
 one report of syncope (fainting) with injury
 one report of cellulitis


AEFI REPORTS WITH FATAL OUTCOME

The
remaining four serious AEFIs were reports of death following receipt of COVID-19 vaccine that met the provincial surveillance definition (i.e., other severe/unusual event). One report of death occurred in a resident of a health-care institution with significant co-morbidities. The cause of death was not attributed to the vaccine. The second report of death occurred in a community dwelling senior with complex cardiovascular and renal conditions, wherein the AEFI may have contributed to but was not the underlying cause of death. The third report of death occurred in a community dwelling senior with multiple comorbidities including heart disease and an autoimmune disorder. The cause of death was not attributed to the vaccine. The fourth report of death was recorded in CCM in an individual with VITT (described above under Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) and Thrombosis with Thrombocytopenia Syndrome (TTS)).


Reports of death temporally associated with receipt of vaccine

In Ontario, all deaths temporally associated with receipt of vaccines that have been reported to public health units are thoroughly investigated and reported to PHO. As of June 19, 2021, there are 28 reports of deaths temporally associated with receipt of COVID-19 vaccine that are currently classified as ‘persons under investigation’ as they do not currently meet the provincial surveillance definition. These investigations are ongoing and additional information including a cause of death (e.g., autopsy or Coroner’s report) is expected. Preliminary information suggests that these events occurred in individuals with multiple co-morbidities which may be related to the cause of death. Five of the 28 reports are inlong-term care home (LTCH)/retirement home residents. There has been no association with vaccine identified at this time. Reports of death that meet the provincial case definition are events temporally associated with vaccine that have not been clearly attributed to other causes; these reports should not be interpreted as causally related with vaccine.

During the first few months of the COVID-19 vaccination campaign, LTCH/retirement home residents have been a focus for vaccination efforts. In this population, it was expected that deaths may occur close to the time of vaccination and require further evaluation to determine the cause of death. After reviewing reports of deaths of very frail elderly individuals vaccinated with Pfizer-BioNTech COVID-19 vaccine, the Global Advisory Committee on Vaccine Safety (GACVC) COVID-19 Vaccine Safety subcommittee concluded that “the current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of Pfizer-BioNTech COVID-19 vaccine”.14 The Centres for Disease Control (CDC) also presented a similar assessment of their analysis at the January 27, 2021 meeting of the Advisory Committee on Immunization Practices (ACIP) in the United States that mortality in LTCH residents is high and substantial numbers of deaths in this population are expected, unrelated to vaccination.15 PHO continues to conduct continuous monitoring of the safety of COVID-19 vaccines in collaboration with its partners, including individual case review of all serious AEFIs including reports of death temporally association with receipt of vaccine, daily analysis of surveillance data for vaccine safety signals and weekly reporting on the PHO website and to the Public Health Agency of Canada.
 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
24,722
荣誉分数
6,118
声望点数
373
12月13日至6月26日,总接种将近14 millions,共257例严重不良反应,10万分之1.8。其中每十万剂疫苗发生严重不良反应:辉瑞1.2,Moderna: 1.6, AZ:8。

257位严重不良反应患者中有251位住院治疗,在提交报告时,80位病人已经康复,128位仍在治疗。

阿斯利康疫苗共发生21例血小板减少症(TTS),2.4 / 10万 = 1 / 41000,其中16例确诊由疫苗诱导的免疫性血小板减少症(VITT),1.9 / 10万 = 1 / 54000, 5例确诊与疫苗无关。一例VITT患者死亡报告,死因正在调查,尚未确定。

截止6月26日,安大略省已收到 42 例在接受 COVID19 mRNA 疫苗后出现心肌炎或心包炎的报告,21例需要住院治疗,辉瑞31例,莫德纳11,31例男性,11例女性,男性占74%。年龄范围在 15 至 78 岁之间(中位数为 26 岁); 症状多发生于青少年和轻年男性,第二针后一周之内,通常在4 - 5天。

共有28人死亡暂时可能与疫苗相关,其中5人是老人院成员。4例死亡与严重不良反应有关,其中3例主要由其他基础病引起,一例为疫苗诱发血小板减少性血栓造成。
Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to June 26, 2021

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Figure 1. Number of AEFI reports and doses administered by week of COVID-19 vaccine administration: Ontario, December 13, 2020 to June 26, 2021

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Note: AEFI reports are assessed based on date of vaccine administration. The administration week ranges from week 51 (Dec 13 to 19, 2020) to week 25 (June 20 - 26, 2021). The number of AEFI reports for the recent reporting weeks are subject to reporting delays and/or delayed data entry (i.e., reports are likely to be still under investigation and yet to be reported as a confirmed AEFI report). Data corrections or updates can result in AEFI reports being removed and/or updated from past reports and may result in counts differing from past publicly reported AEFIs.


VACCINE-INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA (VITT) AND THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS)

Thrombosis with Thrombocytopenia Syndrome (TTS) is a condition characterized by the presence of acute venous or arterial thrombosis with new onset thrombocytopenia (low levels of platelets), and no known recent exposure to heparin.7 A case finding definition proposed by the Brighton Collaboration is being used to support the investigation of this new clinical syndrome by identifying individuals who present with TTS following COVID-19 vaccination.7Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) refers to the clinical syndrome of TTS, in addition to laboratory tests that confirm platelet activation (i.e., anti-platelet 4 antibodies). VITT has been reported following immunization with COVID-19 adenoviral vector vaccines, including AstraZeneca/COVISHIELD vaccine.

On May 11, 2021, Ontario announced a pause on the administration of first doses of the AstraZeneca vaccine out of an abundance of caution due to an observed increase in reports of TTS/VITT. However, based on the lag period from vaccination to subsequent symptom onset, clinical recognition and reporting to the vaccine safety surveillance system, there may be additional reports of TTS/VITT reported in the coming weeks.

To date, there have been 21 reports of TTS following the first dose of AstraZeneca/COVISHIELD vaccine in Ontario (including one probable TTS); of these, 16 are confirmed as VITT with positive anti-PF4 antibody test results. The remaining five TTS events that are not classified as VITT have had VITT ruled out through testing (n=4) or did not have confirmatory tests ordered (n=1). There has also been one report of TTS following a first dose of Moderna vaccine, which is not classified as VITT.

The most recent event following AstraZeneca/COVISHIELD vaccine had a vaccination date of May 6, 2021 and all 21 reports of TTS/VITT associated with AstraZeneca/COVISHIELD vaccine have occurred after receipt of the first dose. There has been one report of death recorded in CCM that has occurred in an individual with VITT. The investigation of this death is ongoing and a cause of death has not been determined at this time.

The following reporting rates are based on the number of first doses of AstraZeneca/COVISHIELD vaccines administered in Ontario as of May 15, 2021 (863,254 doses) as the denominator, which is four days after Ontario’s announcement on the pause of the administration of first doses of the AstraZeneca vaccine. The reporting rate of TTS based on 21 reports is 2.4 per 100,000 first doses administered (approximately 1 in 41,000). The reporting rate of VITT (as a subtype of TTS) based on 16 reports is 1.9 per 100,000 first doses administered (approximately 1 in 54,000). Reporting rate calculations are subject to changes over time including additional events that are diagnosed and reported to the vaccine safety surveillance system.


MYOCARDITIS/PERICARDITIS

There have been international reports, including from the United States and Israel, of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with COVID-19 mRNA vaccines.9,10 Information to date indicates that these events occur more commonly after the second dose, within the week following vaccination (typically within 4-5 days), mainly in adolescents/young adults and more often in males than female.

The Public Health Agency of Canada (PHAC) and Health Canada are closely monitoring these events in passive and active Canadian vaccine safety surveillance systems to study the association between myocarditis/pericarditis and COVID-19 mRNA vaccine.

As of June 26, 2021, there have been 42 reports of myocarditis or pericarditis following receipt of COVID-19 mRNA vaccines in Ontario. Of these, nine (21.4%) were diagnosed with myocarditis and 21 (50.0%) were diagnosed with pericarditis. The remaining 12 were diagnosed with perimyocarditis (n=1), myopericarditis (n=9), inflammatory cardiac reaction of unclear significance (n=1) or unknown diagnosis at the time of reporting (n=1). The nine reports of myocarditis have been assessed using the Brighton Collaboration case definition for myocarditis; eight reports met Brighton levels of diagnostic certainty 1 or 2 and one report had insufficient evidence to meet level 1, 2 or 3 of the case definition. 12 A Brighton Collaboration case definition for pericarditis is under development and will be applied to Ontario events once available. See Table 3 for further characteristics of myocarditis/pericarditis reports.

Of the 42 reports of myocarditis or pericarditis, 21 (50.0%) individuals required hospitalization with some variation by age group. In the 12-17 year age group, three of the ten reports required hospitalization (30.0%) and in the 25-29 year age group, five of the six reports required hospitalization (83.3%). The proportion of reports that required hospitalization should be interpreted with caution due to the small number of reports within these age groups. Among the 16 reports where both the date of admission and discharge was available for review, the median length of stay was two days.

Ontario is continuing to monitor these events in collaboration with its partners and weekly updates can be found within this report and on the PHAC website. Please see PHO’s At A Glance: Myocarditis and Pericarditis Following COVID-19 mRNA Vaccines for more information on this topic.


Table 3. Characteristics of myocarditis or pericarditis reports received to date following mRNA COVID-19 vaccines: Ontario, December 13, 2020 to June 26, 2021

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Note: Some reports are missing time to onset as the investigation is still ongoing.


Serious AEFIs

In Ontario, AEFIs that meet the serious definition are events that required hospital admission and reports of death (see the technical notes for a full definition). There were 257 AEFI reports classified as serious, representing 4.0% of all AEFI reports and a serious AEFI reporting rate of 1.8 per 100,000 doses administered for all vaccine products combined. As a comparison, the proportion of AEFIs defined as serious for all vaccines administered in Ontario ranged from 2.8% and 5.0% between 2012 and 2018.14 The serious reporting rate was 1.2 and 1.6 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rates for the AstraZeneca/COVISHIELD vaccine was 8.0 per 100,000 doses administered.

AEFI REPORTS REQUIRING HOSPITALIZATION

251 clients of the 257 serious reports had a hospital admission related to the reported events. Of the 251 clients, 80 had recovered at the time of reporting, 128 were not yet recovered when the investigation was completed but likely to recover, and 19 had an unknown outcome at the time of reporting. Twenty-four reports had an outcome reported as “residual effects”, which is defined as residual disability or sequelae related to the reported event. Due to the relatively short follow-up time for AEFIs reported in CCM, it is uncertain whether these residual effects will resolve, but had not yet resolved at the time of reporting.

When a serious report contained multiple adverse events, one event that was the prominent reason for reporting was chosen to describe the serious report. Of the 251 reports of hospitalizations, 113 reported an AESI, 53 reported a medically important event, and six reported both a medically important event and an AESI (described in the AESI section and the medically important events section). The remaining 79 reports were:

 55 reports of other severe or unusual events
 eight reports of severe vomiting/diarrhea
 five reports of convulsion/seizure Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario 10
 four reports of arthritis/arthralgia
 three reports of anaesthesia/paraesthesia
 one report of paralysis
 one report of Bell’s Palsy
 one report of syncope (fainting) with injury
 one report of cellulitis


AEFI REPORTS WITH FATAL OUTCOME

The remaining six serious AEFIs were reports of death following receipt of COVID-19 vaccine that met the provincial surveillance definition (i.e., other severe/unusual event) as follows:

 Resident of a health-care institution with significant co-morbidities. The cause of death was not attributed to the vaccine.
 Community dwelling senior with complex cardiovascular and renal conditions, wherein the AEFI may have contributed to but was not the underlying cause of death.
 Community dwelling senior with multiple comorbidities including heart disease and an autoimmune disorder. The cause of death was not attributed to the vaccine.
 An individual with VITT with death recorded in CCM (described above under Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) and Thrombosis with Thrombocytopenia Syndrome (TTS)).
 Individual with hypertension, wherein the cause of death was not clearly attributed to vaccine.
 Community dwelling senior with a complex cardiovascular history. The AEFI may have contributed to but was not the underlying cause of death.


Reports of death temporally associated with receipt of vaccine

In Ontario, all deaths temporally associated with receipt of vaccines that have been reported to public health units are thoroughly investigated and reported to PHO. As of June 26, 2021, there are 28 reports of deaths temporally associated with receipt of COVID-19 vaccine that are currently classified as ‘persons under investigation’ as they do not currently meet the provincial surveillance definition. These investigations are ongoing and additional information including a cause of death (e.g., autopsy or Coroner’s report) is expected. Preliminary information suggests that these events occurred in individuals with multiple co-morbidities which may be related to the cause of death. Five of the 28 reports are in long-term care home (LTCH)/retirement home residents. There has been no association with vaccine identified at this time. Reports of death that meet the provincial case definition are events temporally associated with vaccine that have not been clearly attributed to other causes; these reports should not be interpreted as causally related with vaccine.

During the first few months of the COVID-19 vaccination campaign, LTCH/retirement home residents have been a focus for vaccination efforts. In this population, it was expected that deaths may occur close to the time of vaccination and require further evaluation to determine the cause of death. After reviewing reports of deaths of very frail elderly individuals vaccinated with Pfizer-BioNTech COVID-19 vaccine, the Global Advisory Committee on Vaccine Safety (GACVC) COVID-19 Vaccine Safety subcommittee concluded that “the current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of Pfizer-BioNTech COVID-19 vaccine”.15 The Centres for Disease Control (CDC) also presented a similar assessment of their analysis at the January 27, 2021 meeting of the Advisory Committee on Immunization Practices (ACIP) in the United States that mortality in LTCH residents is high and substantial numbers of deaths in this population are expected, unrelated to vaccination.16 PHO continues to conduct continuous monitoring of the safety of COVID-19 vaccines in collaboration with its partners, including individual case review of all serious AEFIs including reports of death temporally association with receipt of vaccine, daily analysis of surveillance data for vaccine safety signals and weekly reporting on the PHO website and to the Public Health Agency of Canada.
 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
24,722
荣誉分数
6,118
声望点数
373
12月13日至7月3日,总接种将近15.5 millions,共299例严重不良反应,10万分之1.9。其中每十万剂疫苗发生严重不良反应:辉瑞1.4,Moderna: 1.7, AZ:8.3。

299位严重不良反应患者中有293位住院治疗,在提交报告时,93位病人已经康复,149位仍在治疗,总结报告见表4。

阿斯利康疫苗共发生21例血小板减少症(TTS),与上周报告无变化。2.4 / 10万 = 1 / 41000,其中16例确诊由疫苗诱导的免疫性血小板减少症(VITT),1.9 / 10万 = 1 / 54000, 5例确诊与疫苗无关。一例VITT患者死亡报告,死因正在调查,尚未确定。

截止7月3日,安大略省已收到 74 例在接受 COVID19 mRNA 疫苗后出现心肌炎或心包炎的报告,43例需要住院治疗,辉瑞46例,莫德纳28,57例男性,17例女性,男性占77%。年龄范围在 12 至 79 岁之间(中位数为 25 岁); 症状多发生于青少年和轻年男性,更常见于第二针后一周之内,通常在4 - 5天。

共有29人死亡暂时可能与疫苗相关,其中5人是老人院成员。4例死亡与严重不良反应有关,其中3例主要由其他基础病引起,一例为疫苗诱发血小板减少性血栓造成。

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to July 3, 2021

Highlights

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Figure 1. Number of AEFI reports and doses administered by week of COVID-19 vaccine administration: Ontario, December 13, 2020 to July 3, 2021

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Note: AEFI reports are assessed based on date of vaccine administration. The administration week ranges from week 51 (Dec 13 to 19, 2020) to week 26 (June 27 – July 3, 2021). The number of AEFI reports for the recent reporting weeks are subject to reporting delays and/or delayed data entry (i.e., reports are likely to be still under investigation and yet to be reported as a confirmed AEFI report). Data corrections or updates can result in AEFI reports being removed and/or updated from past reports and may result in counts differing from past publicly reported AEFIs.


VACCINE-INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA (VITT) AND THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS)

No change.

MYOCARDITIS/PERICARDITIS

There have been international reports, including from the United States and Israel, of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with COVID-19 mRNA vaccines.11,12 Information to date indicates that these events occur
more commonly after the second dose, within the week following vaccination (typically within 4-5 days), mainly in adolescents/young adults and more often in males than female.

PHAC and Health Canada are closely monitoring these events in passive and active Canadian vaccine safety surveillance systems.

As of July 3, 2021, there have been 74 reports of myocarditis or pericarditis following receipt of COVID19 mRNA vaccines in Ontario. Of these, 22 (29.7%) were diagnosed with myocarditis and 35 (47.3%) were diagnosed with pericarditis. The remaining 17 were diagnosed with perimyocarditis (n=1), myopericarditis (n=15) or inflammatory cardiac reaction of unclear significance (n=1). In addition, there are 29 reports classified as ‘persons under investigation’ (16 after dose one; 12 after dose two; 1 with unknown dose number) as public health units are still collecting additional information on the AEFI report. The 22 reports of myocarditis have been assessed using the Brighton Collaboration case definition for myocarditis; 21 reports met Brighton levels of diagnostic certainty 1 or 2 and one report had insufficient evidence to meet level 1, 2 or 3 of the case definition. 14 In the absence of a Brighton Collaboration case definition for pericarditis (under development), the CDC case definition for pericarditis was applied to Ontario events. Of the 35 reports of pericarditis, 22 (62.9%) met the CDC case definition for pericarditis. See Table 3 for further characteristics of myocarditis/pericarditis reports.


Of the 74 reports of myocarditis or pericarditis, 43 (58.1%) individuals required hospitalization with some variation by age group. In the 12-17 year age group, five of the 12 reports required hospitalization (41.7%) and in the 25-29 year age group, eight of the nine reports required hospitalization (88.9%).
The proportion of reports that required hospitalization should be interpreted with caution due to the small number of reports within these age groups. Among the 33 reports where both the date of admission and discharge was available for review, the median length of stay was two days.

Ontario is continuing to monitor these events in collaboration with its partners and weekly updates can be found within this report and on the PHAC website. Please see PHO’s At A Glance: Myocarditis and Pericarditis Following COVID-19 mRNA Vaccines for more information on this topic.


Table 3. Characteristics of myocarditis or pericarditis reports received to date following COVID-19 mRNA vaccines: Ontario, December 13, 2020 to July 3, 2021

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Note: One report with time to onset of 71 days following dose 2 and three reports with unknown time to onset have been excluded from the calculation of median time to onset and range.


Serious AEFIs

In Ontario, AEFIs that meet the serious definition are events that required hospital admission and reports of death (see the technical notes for a full definition). There were 299 AEFI reports classified as serious, representing 4.3% of all AEFI reports and a serious AEFI reporting rate of 1.9 per 100,000 doses administered for all vaccine products combined. As a comparison, the proportion of AEFIs defined as serious for all vaccines administered in Ontario ranged from 2.8% and 5.0% between 2012 and 2018.16 The serious reporting rate was 1.4 and 1.7 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rate for the AstraZeneca/COVISHIELD vaccine was 8.3 per 100,000 doses administered.

AEFI REPORTS REQUIRING HOSPITALIZATION

293 clients of the 299 serious reports had a hospital
admission related to the reported events. Table 4 summarizes the outcome of the 293 clients at the time of reporting and the event that was the prominent reason for hospitalization.

Table 4. Summary of outcomes and events for AEFI reports requiring hospitalization: Ontario, December 13, 2020 to July 3, 2021

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Note: * an outcome reported as “residual effects” is defined as residual disability or sequelae related to the reported event. Due to the relatively short follow-up time for AEFIs reported in CCM, it is uncertain whether these residual effects will resolve, but had not yet resolved at the time of reporting.


AEFI REPORTS WITH FATAL OUTCOME

The remaining six serious AEFIs were reports of death following receipt of COVID-19 vaccine that met the provincial surveillance definition (i.e., other severe/unusual event) as follows:

 Resident of a health-care institution with significant co-morbidities. The cause of death was not attributed to the vaccine.
 Community dwelling senior with complex cardiovascular and renal conditions, wherein the AEFI may have contributed to but was not the underlying cause of death.
 Community dwelling senior with multiple comorbidities including heart disease and an autoimmune disorder. The cause of death was not attributed to the vaccine.
 An individual with VITT with death recorded in CCM (described above under Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) and Thrombosis with Thrombocytopenia Syndrome (TTS)).
 Individual with hypertension, wherein the cause of death was not clearly attributed to vaccine.
 Community dwelling senior with a complex cardiovascular history. The AEFI may have contributed to but was not the underlying cause of death.


Reports of death temporally associated with receipt of vaccine

In Ontario, all deaths temporally associated with receipt of vaccines that have been reported to public health units are thoroughly investigated and reported to PHO. As of July 3, 2021, there are 29 reports of deaths temporally associated with receipt of COVID-19 vaccine that are currently classified as ‘persons under investigation’ as they do not currently meet the provincial surveillance definition. These investigations are ongoing and additional information including a cause of death (e.g., autopsy or Coroner’s report) is expected. Preliminary information suggests that these events occurred in individuals with multiple co-morbidities which may be related to the cause of death.
Five of the 29 reports are in long-term care home (LTCH)/retirement home residents.
There has been no association with vaccine identified at this time. Reports of death that meet the provincial case definition are events temporally associated with vaccine that have not been clearly attributed to other causes; these reports should not be interpreted as causally related with vaccine.

During the first few months of the COVID-19 vaccination campaign, LTCH/retirement home residents have been a focus for vaccination efforts. In this population, it was expected that deaths may occur close to the time of vaccination and require further evaluation to determine the cause of death. After reviewing reports of deaths of very frail elderly individuals vaccinated with Pfizer-BioNTech COVID-19 vaccine, the Global Advisory Committee on Vaccine Safety (GACVC) COVID-19 Vaccine Safety subcommittee concluded that “the current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of Pfizer-BioNTech COVID-19 vaccine”.17 The Centres for Disease Control (CDC) also presented a similar assessment of their analysis at the January 27, 2021 meeting of the Advisory Committee on Immunization Practices (ACIP) in the United States that mortality in LTCH residents is high and substantial numbers of deaths in this population are expected, unrelated to vaccination.18 PHO continues to conduct continuous monitoring of the safety of COVID-19 vaccines in collaboration with its partners, including individual case review of all serious AEFIs including reports of death temporally association with receipt of vaccine, daily analysis of surveillance data for vaccine safety signals and weekly reporting on the PHO website and to the Public Health Agency of Canada.
 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
24,722
荣誉分数
6,118
声望点数
373
12月13日至7月10日,总接种将近17 millions,共336例严重不良反应,10万分之2。其中每十万剂疫苗发生严重不良反应:辉瑞1.5,Moderna: 1.8, AZ:8.2。大约3/4的不良反应由第一针引发,12%与第二针有关。

336位严重不良反应患者中有330位住院治疗,在提交报告时,107位病人已经康复出院,167位仍在治疗,总结报告见表4。

阿斯利康疫苗共发生21例血小板减少症(TTS),与上周报告无变化。2.4 / 10万 = 1 / 41000,其中16例确诊由疫苗诱导的免疫性血小板减少症(VITT),1.9 / 10万 = 1 / 54000, 5例确诊与疫苗无关。一例VITT患者死亡报告,死因正在调查,尚未确定。

截止7月10日,安大略省已收到 99 例在接受 COVID19 mRNA 疫苗后出现心肌炎或心包炎的报告,60例需要住院治疗,辉瑞57例,莫德纳42,72例男性,27例女性,男性占73%。年龄范围在 12 至 79 岁之间(中位数为 25 岁); 症状多发生于青少年和轻年男性(18 - 24岁),更常见于第二针后一周之内,通常在4 - 5天。比率为85.4/million = 1/12,000.

共有29人死亡暂时可能与疫苗相关,其中5人是老人院成员。4例死亡与严重不良反应有关,其中3例主要由其他基础病引起,一例为疫苗诱发血小板减少性血栓造成。

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to July 10, 2021

Highlights

 There are a total of 7,651 AEFI reports received following 16,981,460 doses of COVID-19 vaccines administered in Ontario to date with a reporting rate of 45.1 per 100,000 doses administered (0.05% of all doses administered)
 This represents an increase of 694 AEFI reports compared to previous week
 Of the total 7,651 AEFI reports received to date:
 7,315 AEFI reports are non-serious (95.6% of total AEFI reports)
 336 AEFI reports meet the serious definition (4.4% of total AEFI reports)
 The most commonly reported adverse events are allergic skin reactions and pain/redness/swelling at the injection site, reported in 26.7% and 22.4% of the total AEFI reports respectively
 281 reports of events managed as anaphylaxis are reported, in which 20 reports also meet the serious definition (see Events Managed As Anaphylaxis section for more information)
 19 reports of Guillain-Barré Syndrome (see Guillain-Barré Syndrome section for more information)
 363 reports include a COVID-19 vaccine-specific adverse event of special interest, in which 180 reports also meet the serious definition (see Adverse events of special interest section for more information)
 21 reports of thrombosis with thrombocytopenia syndrome (TTS) after receipt of AstraZeneca/COVISHIELD vaccine, of which 16 are vaccine-induced immune thrombotic thrombocytopenia (VITT) (see TTS/VITT section for more information)
 99 reports of myocarditis or pericarditis after receipt of mRNA vaccine (see Myocarditis/pericarditis section for more information)


Summary of AEFI reports in Ontario

An AEFI report refers to a report received by the PHU, which pertains to one individual vaccine recipient who reported at least one adverse event after receiving the COVID-19 vaccine (i.e., temporally associated with the vaccine).

See Table 1 for a summary of all AEFI reports received to date in Ontario. Of the total number of AEFI reports, 75.7% are reported to be associated with the first dose of COVID-19 vaccination (using the information from CCM) whereas 11.9% are reported to be associated with the second dose. The remaining reports have unknown or missing dose number in CCM.


1626310329124.png
1626310306450.png


1626310743220.png
1626310751457.png


Figure 1. Number of AEFI reports and doses administered by week of COVID-19 vaccine administration: Ontario, December 13, 2020 to July 10, 2021
1626310868139.png

Note: AEFI reports are assessed based on date of vaccine administration. The administration week ranges from week 51 (Dec 13 to 19, 2020) to week 27 (July 4 – 10, 2021). The number of AEFI reports for the recent reporting weeks are subject to reporting delays and/or delayed data entry (i.e., reports are likely to be still under investigation and yet to be reported as a confirmed AEFI report). Data corrections or updates can result in AEFI reports being removed and/or updated from past reports and may result in counts differing from past publicly reported AEFIs.

MYOCARDITIS/PERICARDITIS

There have been international reports, including from the United States and Israel, of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with COVID-19 mRNA vaccines. Information to date indicates that these events occur more commonly after the second dose, within the week following vaccination (typically within 4-5 days), mainly in adolescents/young adults and more often in males than female.

PHAC and Health Canada are closely monitoring these events in passive and active Canadian vaccine safety surveillance systems.

As of July 10, 2021, there have been 99 reports of myocarditis or pericarditis following receipt of COVID19 mRNA vaccines in Ontario. Of these, 28 (28.3%) were diagnosed with myocarditis and 44 (44.4%) were diagnosed with pericarditis. The remaining 27 were diagnosed with perimyocarditis (n=2), myopericarditis (n=24) or inflammatory cardiac reaction of unclear significance (n=1). The 28 reports of myocarditis have been assessed using the Brighton Collaboration case definition for myocarditis; 27 reports met Brighton levels of diagnostic certainty 1 or 2 and one report had insufficient evidence to meet level 1, 2 or 3 of the case definition. 14 In the absence of a Brighton Collaboration case definition for pericarditis (under development), the CDC case definition for pericarditis was applied to Ontario events. Of the 44 reports of pericarditis, 23 (52.9%) met the CDC case definition for pericarditis, 12 (27.3%) did not meet the CDC case definition for pericarditis, and nine reports are still under review (20.5%). See Table 3 for further characteristics of myocarditis/pericarditis reports.

Of the 99 reports of myocarditis or pericarditis, 60 (60.6%) reports had a hospital admission with some variation by age group. In the 12-17 year age group, eight of the 15 reports required hospitalization (53.3%) whereas in the 25-29 year age group, ten of the 11 reports required hospitalization (90.9%). The proportion of reports that required hospitalization should be interpreted with caution due to the small number of reports within these age groups. Among the 48 reports where both the date of admission and discharge was available for review, the median length of stay was two days.

Based on 99 reports of myocarditis or pericarditis, the overall reporting rate is 6.2 per million doses of mRNA vaccines administered. The highest reporting rates were observed in younger age groups (12-17 and 18-24 years) and among males. The highest reporting rate was observed for males aged 18-24 years of age following dose 2, at 85.4 events per million doses administered (approximately 1 in 12,000 doses administered). Table A3 in Appendix A presents the reporting rate of myocarditis or pericarditis by age group, gender and dose number.

Additionally, there are 41 reports classified as ‘persons under investigation’ (18 after dose one; 21 after dose two; two with unknown dose number) as public health units are still collecting additional information on the AEFI report. Ontario is continuing to monitor these events in collaboration with its partners and weekly updates can be found within this report and on the PHAC website. Please see PHO’s At A Glance: Myocarditis and Pericarditis Following COVID-19 mRNA Vaccines for more information on this topic.

Table 3. Characteristics of myocarditis or pericarditis reports received to date following COVID-19 mRNA vaccines: Ontario, December 13, 2020 to July 10, 2021
1626312148579.png

Note: One report with time to onset of 71 days following dose 2 and four reports with unknown time to onset have been excluded from the calculation of median time to onset and range.

Serious AEFIs

In Ontario, AEFIs that meet the serious definition are events that required hospital admission and reports of death (see the technical notes for a full definition). There were 336 AEFI reports classified as serious, representing 4.4% of all AEFI reports and a serious AEFI reporting rate of 2.0 per 100,000 doses administered for all vaccine products combined. As a comparison, the proportion of AEFIs defined as serious for all vaccines administered in Ontario ranged from 2.8% and 5.0% between 2012 and 2018.16 The serious reporting rate was 1.5 and 1.8 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rate for the AstraZeneca/COVISHIELD vaccine was 8.2 per 100,000 doses administered.

AEFI REPORTS REQUIRING HOSPITALIZATION

Of the 336 reports meeting the serious definition, 330 reports had a hospital admission related to the reported events. Table 4 summarizes the outcome of the 330 reports at the time of reporting and the event that was the prominent reason for hospitalization.

Table 4. Summary of outcomes and events for AEFI reports requiring hospitalization: Ontario, December 13, 2020 to July 10, 2021

1626314328459.png


1626314412167.png

Note: * an outcome reported as “residual effects” is defined as residual disability or sequelae related to the reported event. Due to the relatively short follow-up time for AEFIs reported in CCM, it is uncertain whether these residual effects will resolve, but had not yet resolved at the time of reporting.

AEFI REPORTS WITH FATAL OUTCOME


The remaining six serious AEFIs were reports of death following receipt of COVID-19 vaccine that met the provincial surveillance definition (i.e., other severe/unusual event) as follows:

 Resident of a health-care institution with significant co-morbidities. The cause of death was not attributed to the vaccine.
 Community dwelling senior with complex cardiovascular and renal conditions, wherein the AEFI may have contributed to but was not the underlying cause of death.
 Community dwelling senior with multiple comorbidities including heart disease and an autoimmune disorder. The cause of death was not attributed to the vaccine.
 An individual with VITT with death recorded in CCM (described above under Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) and Thrombosis with Thrombocytopenia Syndrome (TTS)).
 Individual with hypertension, wherein the cause of death was not clearly attributed to vaccine.
 Community dwelling senior with a complex cardiovascular history. The AEFI may have contributed to but was not the underlying cause of death.


Reports of death temporally associated with receipt of vaccine


In Ontario, all deaths temporally associated with receipt of vaccines that have been reported to public health units are thoroughly investigated and reported to PHO. As of July 10, 2021, there are 29 reports of deaths temporally associated with receipt of COVID-19 vaccine that are currently classified as ‘persons under investigation’ as they do not currently meet the provincial surveillance definition. These investigations are ongoing and additional information including a cause of death (e.g., autopsy or Coroner’s report) is expected. Preliminary information suggests that these events occurred in individuals with multiple co-morbidities which may be related to the cause of death. Five of the 29 reports are in long-term care home (LTCH)/retirement home residents. There has been no association with vaccine identified at this time. Reports of death that meet the provincial case definition are events temporally associated with vaccine that have not been clearly attributed to other causes; these reports should not be interpreted as causally related with vaccine.

During the first few months of the COVID-19 vaccination campaign, LTCH/retirement home residents have been a focus for vaccination efforts. In this population, it was expected that deaths may occur close to the time of vaccination and require further evaluation to determine the cause of death. After reviewing reports of deaths of very frail elderly individuals vaccinated with Pfizer-BioNTech COVID-19 vaccine, the Global Advisory Committee on Vaccine Safety (GACVC) COVID-19 Vaccine Safety subcommittee concluded that “the current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of Pfizer-BioNTech COVID-19 vaccine”. The Centres for Disease Control (CDC) also presented a similar assessment of their analysis at the January 27, 2021 meeting of the Advisory Committee on Immunization Practices (ACIP) in the United States that mortality in LTCH residents is high and substantial numbers of deaths in this population are expected, unrelated to vaccination. PHO continues to conduct continuous monitoring of the safety of COVID-19 vaccines in collaboration with its partners, including individual case review of all serious AEFIs including reports of death temporally association with receipt of vaccine, daily analysis of surveillance data for vaccine safety signals and weekly reporting on the PHO website and to the Public Health Agency of Canada.
 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
24,722
荣誉分数
6,118
声望点数
373
12月13日至7月17日,总接种将近18 millions,共336例严重不良反应,10万分之2.2。其中每十万剂疫苗发生严重不良反应:辉瑞1.6,Moderna: 2.3, AZ:8.6。大约74%的不良反应由第一针引发,14%与第二针有关。

399位严重不良反应患者中有393位住院治疗,在提交报告时,134位病人已经康复出院,196位仍在治疗,总结报告见表4。

阿斯利康疫苗共发生21例血小板减少症(TTS),与上周报告无变化。2.4 / 10万 = 1 / 41000,其中16例确诊由疫苗诱导的免疫性血小板减少症(VITT),1.9 / 10万 = 1 / 54000, 5例确诊与疫苗无关。一例VITT患者死亡报告,死因正在调查,尚未确定。

截止7月17日,安大略省已收到 144 例在接受 COVID19 mRNA 疫苗后出现心肌炎或心包炎的报告,87例,占60%,需要住院治疗,辉瑞80例,莫德纳64,109例男性,35例女性,男性占76%。年龄范围在 12 至 80 岁之间(中位数为 24 岁); 症状多发生于青少年和轻年男性(18 - 24岁),更常见于第二针后一周之内,通常在4 - 5天。比率为8.5/million mRNA 疫苗;最高比率出现在接种第二针的18-24岁男性,109/million。

共有29人死亡暂时可能与疫苗相关,其中5人是老人院成员。4例死亡与严重不良反应有关,其中3例主要由其他基础病引起,一例为疫苗诱发血小板减少性血栓造成。

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to July 17, 2021

1626891742227.png
1626891751600.png


Summary of AEFI reports in Ontario

An AEFI report refers to a report received by the PHU, which pertains to one individual vaccine recipient who reported at least one adverse event after receiving the COVID-19 vaccine (i.e., temporally associated with the vaccine).

See Table 1 for a summary of all AEFI reports received to date in Ontario. Of the total number of AEFI reports, 74.0% are reported to be associated with the first dose of COVID-19 vaccination (using the information from CCM) whereas 14.1% are reported to be associated with the second dose. The remaining reports have unknown or missing dose number in CCM.

1626892068712.png
1626892076932.png


1626892274755.png
1626892282736.png


Figure 1. Number of AEFI reports and doses administered by week of COVID-19 vaccine administration: Ontario, December 13, 2020 to July 17, 2021
1626892378572.png

Note: AEFI reports are assessed based on date of vaccine administration. The administration week ranges from week 51 (Dec 13 to 19, 2020) to week 28 (July 11 – 17, 2021). The number of AEFI reports for the recent reporting weeks are subject to reporting delays and/or delayed data entry (i.e., reports are likely to be still under investigation and yet to be reported as a confirmed AEFI report). Data corrections or updates can result in AEFI reports being removed and/or updated from past reports and may result in counts differing from past publicly reported AEFIs.

VACCINE-INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA (VITT) AND THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS)

Same as last time.

MYOCARDITIS/PERICARDITIS


There have been international reports, including from the United States and Israel, of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with COVID-19 mRNA vaccines.11,12 Information to date indicates that these events occur more commonly after the second dose, within the week following vaccination (typically within 4-5 days), mainly in adolescents/young adults and more often in males than female.

PHAC and Health Canada are closely monitoring these events in passive and active Canadian vaccine safety surveillance systems.

As of July 17, 2021, there have been 144 reports of myocarditis or pericarditis following receipt of COVID-19 mRNA vaccines in Ontario. These reports have been identified through case-level review of all reported AEFIs. Of these, 42 (29.2%) were diagnosed with myocarditis and 60 (41.7%) were diagnosed with pericarditis. The remaining 42 were diagnosed with perimyocarditis (n=4), myopericarditis (n=37) or inflammatory cardiac reaction of unclear significance (n=1). The 42 reports of myocarditis have been assessed using the Brighton Collaboration case definition for myocarditis; 40 reports met Brighton levels of diagnostic certainty 1, 2 or 3, one report had insufficient evidence to meet level 1, 2 or 3 of the case definition and one report is still under review. 14 The Brighton Collaboration case definition for pericarditis was applied to Ontario events. 14 Of the 60 reports of pericarditis, 36 reports met Brighton levels of diagnostic certainty 1, 2 or 3 (60.0%) and 21 reports had insufficient evidence to meet level 1, 2 or 3 of the case definition (35.0%). Three reports could not be assessed due to lack of information (5.0%). See Table 3 for further characteristics of myocarditis/pericarditis reports.

Of the
144 reports of myocarditis or pericarditis, 87 (60.4%) reports had a hospital admission with some variation by age group. Among the 71 reports where both the date of admission and discharge was available for review, the median length of stay was two days.

Based on 144 reports of myocarditis or pericarditis, the overall reporting rate is
8.5 per million doses of mRNA vaccines administered. The highest reporting rates were observed in younger age groups (12-17and 18-24 years) and among males. The highest reporting rate was observed for males aged 18-24 years of age following dose 2, at 109.0 events per million doses administered. Table A3 in Appendix A presents the reporting rate of myocarditis or pericarditis by age group, gender and dose number.

Additionally, there are 39 reports classified as ‘persons under investigation’ (17 after dose one; 19 after dose two; three with unknown dose number) as public health units are still collecting additional information on the AEFI report. Ontario is continuing to monitor these events in collaboration with its partners and weekly updates can be found within this report and on the PHAC website. Please see PHO’s At A Glance: Myocarditis and Pericarditis Following COVID-19 mRNA Vaccines for more information on this topic.


Table 3. Characteristics of myocarditis or pericarditis reports received to date following COVID-19 mRNA vaccines: Ontario, December 13, 2020 to July 17, 2021

1626893139749.png


Note: One report with time to onset of 71 days following dose 2 and six reports with unknown time to onset have been excluded from the calculation of median time to onset and range.

Serious AEFIs

In Ontario, AEFIs that meet the serious definition are events that required hospital admission and reports of death (see the technical notes for a full definition). There were 399 AEFI reports classified as serious, representing 4.8% of all AEFI reports and a serious AEFI reporting rate of 2.2 per 100,000 doses administered for all vaccine products combined. As a comparison, the proportion of AEFIs defined as serious for all vaccines administered in Ontario ranged from 2.8% and 5.0% between 2012 and 2018.16 The serious reporting rate was 1.6 and 2.3 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rate for the AstraZeneca/COVISHIELD vaccine was 8.6 per 100,000 doses administered.

AEFI REPORTS REQUIRING HOSPITALIZATION

Of the 399 reports meeting the serious definition, 393 reports had a hospital admission related to the reported events. Table 4 summarizes the outcome of the 393 reports at the time of reporting and the event that was the prominent reason for hospitalization.

Table 4. Summary of outcomes and events for AEFI reports requiring hospitalization: Ontario, December 13, 2020 to July 17, 2021

1626893881745.png
1626893890262.png


Note: * an outcome reported as “residual effects” is defined as residual disability or sequelae related to the reported event. Due to the relatively short follow-up time for AEFIs reported in CCM, it is uncertain whether these residual effects will resolve, but had not yet resolved at the time of reporting.

AEFI REPORTS WITH FATAL OUTCOME

The remaining six serious AEFIs were reports of death following receipt of COVID-19 vaccine that met the provincial surveillance definition (i.e., other severe/unusual event) as follows:

 Resident of a health-care institution with significant co-morbidities. The cause of death was not attributed to the vaccine.
 Community dwelling senior with complex cardiovascular and renal conditions, wherein the AEFI may have contributed to but was not the underlying cause of death.
 Community dwelling senior with multiple comorbidities including heart disease and an autoimmune disorder. The cause of death was not attributed to the vaccine.
 An individual with VITT with death recorded in CCM (described above under Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) and Thrombosis with Thrombocytopenia Syndrome (TTS)).
 Individual with hypertension, wherein the cause of death was not clearly attributed to vaccine.
 Community dwelling senior with a complex cardiovascular history. The AEFI may have contributed to but was not the underlying cause of death.

Reports of death temporally associated with receipt of vaccine

In Ontario, all deaths temporally associated with receipt of vaccines that have been reported to public health units are thoroughly investigated and reported to PHO. As of July 17, 2021, there are 28 reports of deaths temporally associated with receipt of COVID-19 vaccine that are currently classified as ‘persons under investigation’ as they do not currently meet the provincial surveillance definition. These investigations are ongoing and additional information including a cause of death (e.g., autopsy or Coroner’s report) is expected. Preliminary information suggests that these events occurred in individuals with multiple co-morbidities which may be related to the cause of death. Five of the 29 reports are in long-term care home (LTCH)/retirement home residents. There has been no association with vaccine identified at this time. Reports of death that meet the provincial case definition are events temporally associated with vaccine that have not been clearly attributed to other causes; these reports should not be interpreted as causally related with vaccine.

During the first few months of the COVID-19 vaccination campaign, LTCH/retirement home residents have been a focus for vaccination efforts. In this population, it was expected that deaths may occur close to the time of vaccination and require further evaluation to determine the cause of death. After reviewing reports of deaths of very frail elderly individuals vaccinated with Pfizer-BioNTech COVID-19 vaccine, the Global Advisory Committee on Vaccine Safety (GACVC) COVID-19 Vaccine Safety subcommittee concluded that “the current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of Pfizer-BioNTech COVID-19 vaccine”.17 The Centres for Disease Control (CDC) also presented a similar assessment of their analysis at the January 27, 2021 meeting of the Advisory Committee on Immunization Practices (ACIP) in the United States that mortality in LTCH residents is high and substantial numbers of deaths in this population are expected, unrelated to vaccination.18 PHO continues to conduct continuous monitoring of the safety of COVID-19 vaccines in collaboration with its partners, including individual case review of all serious AEFIs including reports of death temporally association with receipt of vaccine, daily analysis of surveillance data for vaccine safety signals and weekly reporting on the PHO website and to the Public Health Agency of Canada.
 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
24,722
荣誉分数
6,118
声望点数
373
12月13日至7月24日,总接种将近19 millions,共445例严重不良反应,10万分之2.4。其中每十万剂疫苗发生严重不良反应:辉瑞1.7,Moderna: 2.6, AZ:8.7。大约73%的不良反应由第一针引发,15.5%与第二针有关。

445位严重不良反应患者中有439位住院治疗,在提交报告时,150位病人已经康复出院,214位仍在治疗,总结报告见表4。

阿斯利康疫苗共发生21例血小板减少症(TTS),与上周报告无变化。2.4 / 10万 = 1 / 41000,其中16例确诊由疫苗诱导的免疫性血小板减少症(VITT),1.9 / 10万 = 1 / 54000, 5例确诊与疫苗无关。一例VITT患者死亡报告,死因正在调查,尚未确定。

截止7月24日,安大略省已收到 179 例在接受 COVID19 mRNA 疫苗后出现心肌炎或心包炎的报告,比上周增加35例。其中110例,占61.5%,需要住院治疗,辉瑞92例,莫德纳87,141例男性,38例女性,男性占79%。年龄范围在 12 至 79 岁之间(中位数为 24 岁); 症状多发生于青少年和轻年男性(18 - 24岁),更常见于第二针后一周之内,通常在4 - 5天。比率为10/million mRNA 疫苗;最高比率出现在接种第二针的18-24岁男性,130/million。

共有27人死亡暂时可能与疫苗相关,其中5人是老人院成员。4例死亡与严重不良反应有关,其中3例主要由其他基础病引起,一例为疫苗诱发血小板减少性血栓造成。

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to July 24, 2021

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1627527544824.png


1627527632765.png


Table 1. Summary of all AEFI reports received to date by COVID-19 vaccine: Ontario, December 13, 2020 to July 24, 2021

1627527970454.png

1627527995133.png


Table 2. Summary of all AEFI reports received to date by age group and gender: Ontario, December 13, 2020 to July 24, 2021

1627528193934.png
1627528199550.png


Figure 1. Number of AEFI reports and doses administered by week of COVID-19 vaccine administration: Ontario, December 13, 2020 to July 24, 2021

1627529056269.png


Note: AEFI reports are assessed based on date of vaccine administration. The administration week ranges from week 51 (Dec 13 to 19, 2020) to week 29 (July 18 – 24, 2021). The number of AEFI reports for the recent reporting weeks are subject to reporting delays and/or delayed data entry (i.e., reports are likely to be still under investigation and yet to be reported as a confirmed AEFI report). Data corrections or updates can result in AEFI reports being removed and/or updated from past reports and may result in counts differing from past publicly reported AEFIs.


VACCINE-INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA (VITT) AND THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS)

Same as before.

MYOCARDITIS/PERICARDITIS

There have been international reports, including from the United States and Israel, of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with COVID-19 mRNA vaccines. Information to date indicates that these events occur
more commonly after the second dose, within the week following vaccination (typically within 4-5 days), mainly in adolescents/young adults and more often in males than females.

PHAC and Health Canada are closely monitoring these events in passive and active Canadian vaccine safety surveillance systems.

As of July 24, 2021, there have been 179 reports of myocarditis or pericarditis following receipt of COVID-19 mRNA vaccines in Ontario. These reports have been identified through case-level review of all reported AEFIs. Of these, 51 (28.5%) were diagnosed with myocarditis and 70 (39.1%) were diagnosed with pericarditis. The remaining 58 were diagnosed with perimyocarditis (n=7), myopericarditis (n=50) or inflammatory cardiac reaction of unclear significance (n=1). The 51 reports of myocarditis have been assessed using the Brighton Collaboration case definition for myocarditis; 48 reports met Brighton levels of diagnostic certainty 1, 2 or 3 (94.1%), two reports had insufficient evidence to meet level 1, 2 or 3 of the case definition (3.9%) and one report did not meet the Brighton Collaboration case definition for myocarditis (2.0%). 14 Of the 70 reports of pericarditis assessed using the Brighton Collaboration case definition for pericarditis, 43 reports met Brighton levels of diagnostic certainty 1, 2 or 3 (61.4%), 23 reports had insufficient evidence to meet level 1, 2 or 3 of the case definition (32.9%), and two reports did not meet the Brighton Collaboration case definition for myocarditis (2.9%). 14 Two reports could not be assessed due to lack of information. See Table 3 for further characteristics of myocarditis/pericarditis reports.

Of the
179 reports of myocarditis or pericarditis, 110 (61.5%) reports had a hospital admission with some variation by age group. Among the 92 reports where both the date of admission and discharge was available for review, the median length of stay was two days.

Based on 179 reports of myocarditis or pericarditis, the overall crude reporting rate is
10.0 per million doses of mRNA vaccines administered. The highest reporting rates were observed in younger age groups (12-17 and 18-24 years) and among males. The highest reporting rate was observed for males aged 18- 24 years of age following dose 2, at 130.2 events per million doses administered. Table A3 in Appendix A presents the reporting rate of myocarditis or pericarditis by age group, gender and dose number. The reporting rates are calculated by including all reports of myocarditis or pericarditis identified through case-level review, regardless of whether they meet the Brighton Collaboration case definition for myocarditis or pericarditis.

Additionally, there are 56 reports classified as ‘persons under investigation’ as public health units are still collecting additional information on the AEFI report. Ontario is continuing to monitor these events in collaboration with its partners and weekly updates can be found within this report and on the PHAC website. Please see PHO’s At A Glance: Myocarditis and Pericarditis Following COVID-19 mRNA Vaccines for more information on this topic.15


Table 3. Characteristics of myocarditis or pericarditis reports received to date following COVID-19 mRNA vaccines: Ontario, December 13, 2020 to July 24, 2021

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Note: Twelve reports with unknown time to onset have been excluded from the calculation of median time to onset and range.

Serious AEFIs

In Ontario, AEFIs that meet the serious definition are events that required hospital admission and reports of death (see the technical notes for a full definition). There were 445 AEFI reports classified as serious, representing 4.9% of all AEFI reports and a serious AEFI reporting rate of 2.4 per 100,000 doses administered for all vaccine products combined. As a comparison, the proportion of AEFIs defined as serious for all vaccines administered in Ontario ranged from 2.8% and 5.0% between 2012 and 2018.16 The serious reporting rate was 1.7 and 2.6 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rate for the AstraZeneca/COVISHIELD vaccine was 8.7 per 100,000 doses administered.

AEFI REPORTS REQUIRING HOSPITALIZATION

Of the 445 reports meeting the serious definition, 439 reports had a hospital admission related to the reported events. Table 4 summarizes the outcome of the 439 reports at the time of reporting and the event that was the prominent reason for hospitalization.

Table 4. Summary of outcomes and events for AEFI reports requiring hospitalization: Ontario, December 13, 2020 to July 24, 2021

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Note: * an outcome reported as “residual effects” is defined as residual disability or sequelae related to the reported event. Due to the relatively short follow-up time for AEFIs reported in CCM, it is uncertain whether these residual effects will resolve, but had not yet resolved at the time of reporting.


AEFI REPORTS WITH FATAL OUTCOME

The remaining six serious AEFIs were reports of death following receipt of COVID-19 vaccine that met the provincial surveillance definition (i.e., other severe/unusual event) as follows:

 Resident of a health-care institution with significant co-morbidities. The cause of death was not attributed to the vaccine.
 Community dwelling senior with complex cardiovascular and renal conditions, wherein the AEFI may have contributed to but was not the underlying cause of death.
 Community dwelling senior with multiple comorbidities including heart disease and an autoimmune disorder. The cause of death was not attributed to the vaccine.
 An individual with VITT with death recorded in CCM (described above under Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) and Thrombosis with Thrombocytopenia Syndrome (TTS)).
 Individual with hypertension, wherein the cause of death was not clearly attributed to vaccine.
 Community dwelling senior with a complex cardiovascular history. The AEFI may have contributed to but was not the underlying cause of death.


Reports of death temporally associated with receipt of vaccine

In Ontario, all deaths temporally associated with receipt of vaccines that have been reported to public health units are thoroughly investigated and reported to PHO. As of July 24, 2021, there are 27 reports of deaths temporally associated with receipt of COVID-19 vaccine that are currently classified as ‘persons under investigation’ as they do not currently meet the provincial surveillance definition. These investigations are ongoing and additional information including a cause of death (e.g., autopsy or Coroner’s report) is expected. Preliminary information suggests that these events occurred in individuals with multiple co-morbidities which may be related to the cause of death. Five of the 27 reports are in long-term care home (LTCH)/retirement home residents. There has been no association with vaccine identified at this time. Reports of death that meet the provincial case definition are events temporally associated with vaccine that have not been clearly attributed to other causes; these reports should not be interpreted as causally related with vaccine.

During the first few months of the COVID-19 vaccination campaign, LTCH/retirement home residents have been a focus for vaccination efforts. In this population, it was expected that deaths may occur close to the time of vaccination and require further evaluation to determine the cause of death. After reviewing reports of deaths of very frail elderly individuals vaccinated with Pfizer-BioNTech COVID-19 vaccine, the Global Advisory Committee on Vaccine Safety (GACVC) COVID-19 Vaccine Safety subcommittee concluded that “the current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of Pfizer-BioNTech COVID-19 vaccine”. The Centres for Disease Control (CDC) also presented a similar assessment of their analysis at the January 27, 2021 meeting of the Advisory Committee on Immunization Practices (ACIP) in the United States that mortality in LTCH residents is high and substantial numbers of deaths in this population are expected, unrelated to vaccination. PHO continues to conduct continuous monitoring of the safety of COVID-19 vaccines in collaboration with its partners, including individual case review of all serious AEFIs including reports of death temporally association with receipt of vaccine, daily analysis of surveillance data for vaccine safety signals and weekly reporting on the PHO website and to the Public Health Agency of Canada.
 

woow

吓人也看,坚持把戏看完,,,(⌒▽⌒)
注册
2016-09-08
消息
3,152
荣誉分数
600
声望点数
123
啥都没看见,倒是刷屏手快抽筋了
 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
24,722
荣誉分数
6,118
声望点数
373
12月13日至7月31日,总接种将近19.5 millions,共488例严重不良反应,10万分之2.5。其中每十万剂疫苗发生严重不良反应:辉瑞1.8,Moderna: 3, AZ:8.8。大约71.4%的不良反应由第一针引发,17.1%与第二针有关。

488位严重不良反应患者中有482位住院治疗,在提交报告时,170位病人已经康复出院,224位仍在治疗,总结报告见表4。

阿斯利康疫苗共发生21例血小板减少症(TTS),与上周报告无变化。2.4 / 10万 = 1 / 41000,其中16例确诊由疫苗诱导的免疫性血小板减少症(VITT),1.9 / 10万 = 1 / 54000, 5例确诊与疫苗无关。一例VITT患者死亡报告,死因正在调查,尚未确定。

截止7月31日,安大略省已收到 215 例在接受 COVID19 mRNA 疫苗后出现心肌炎或心包炎的报告,比上周增加36例。其中129例,占60%,需要住院治疗。辉瑞111例,莫德纳104,166例男性,49例女性,男性占77%。年龄范围在 12 至 79 岁之间(中位数为 24 岁); 症状多发生于青少年和轻年男性(18 - 24岁),更常见于第二针后一周之内,通常在4 - 5天。比率为11.7/million mRNA 疫苗;最高比率出现在接种第二针的18-24岁男性,141.3/million。

共有29人死亡暂时可能与疫苗相关,其中5人是老人院成员。4例死亡与严重不良反应有关,其中3例主要由其他基础病引起,一例为疫苗诱发血小板减少性血栓造成。

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to July 31, 2021

Highlights

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Figure 1. Number of AEFI reports and doses administered by week of COVID-19 vaccine administration: Ontario, December 13, 2020 to July 31, 2021
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Note: AEFI reports are assessed based on date of vaccine administration. The administration week ranges from week 51 (Dec 13 to 19, 2020) to week 30 (July 25 – 31, 2021). The number of AEFI reports for the recent reporting weeks are subject to reporting delays and/or delayed data entry (i.e., reports are likely to be still under investigation and yet to be reported as a confirmed AEFI report). Data corrections or updates can result in AEFI reports being removed and/or updated from past reports and may result in counts differing from past publicly reported AEFIs.


VACCINE-INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA (VITT) AND THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS)

Same as last time.

MYOCARDITIS/PERICARDITIS
There have been international reports, including from the United States and Israel, of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with COVID-19 mRNA vaccines.11,12 Information to date indicates that these events occur more commonly after the second dose, within the week following vaccination (typically within 4-5 days), mainly in adolescents/young adults and more often in males than females.

PHAC and Health Canada are closely monitoring these events in passive and active Canadian vaccine safety surveillance systems.

As of July 31, 2021, there have been

215 reports of myocarditis or pericarditis
following receipt of COVID-19 mRNA vaccines in Ontario. These reports have been identified through case-level review of all reported AEFIs. Of these, 61 (28.4%) were diagnosed with myocarditis and 86 (40.0%) were diagnosed with pericarditis. The remaining 68 were diagnosed with perimyocarditis (n=10), myopericarditis (n=57) or inflammatory cardiac reaction of unclear significance (n=1). The 61 reports of myocarditis have been assessed using the Brighton Collaboration case definition for myocarditis; 56 reports met Brighton levels of diagnostic certainty 1, 2 or 3 (91.8%), two reports had insufficient evidence to meet level 1, 2 or 3 of the case definition (3.3%) and three reports did not meet the Brighton Collaboration case definition for myocarditis (4.9%). 14 Of the 86 reports of pericarditis assessed using the Brighton Collaboration case definition for pericarditis, 49 reports met Brighton levels of diagnostic certainty 1, 2 or 3 (57.0%), 30 reports had insufficient evidence to meet level 1, 2 or 3 of the case definition (34.9%), and five reports did not meet the Brighton Collaboration case definition for pericarditis (5.8%). 14 Two reports could not be assessed due to lack of information. See Table 3 for further characteristics of myocarditis/pericarditis reports.

Of the 215 reports of myocarditis or pericarditis, 129 (60.0%) reports had a hospital admission with some variation by age group. Among the 108 reports where both the date of admission and discharge was available for review, the median length of stay was two days.

Based on 215 reports of myocarditis or pericarditis, the overall crude reporting rate is 11.7 per million doses of mRNA vaccines administered. The highest reporting rates were observed in younger age groups (12-17 and 18-24 years) and among males. The highest reporting rate was observed for males aged 18- 24 years of age following dose 2, at 141.3 events per million doses administered. Table A3 in Appendix A presents the reporting rate of myocarditis or pericarditis by age group, gender and dose number. The reporting rates are calculated by including all reports of myocarditis or pericarditis identified through case-level review, regardless of whether they meet the Brighton Collaboration case definition for myocarditis or pericarditis.

Additionally, there are 66 reports classified as ‘persons under investigation’ as public health units are still collecting additional information on the AEFI report. Ontario is continuing to monitor these events in collaboration with its partners and weekly updates can be found within this report and on the PHAC website. Please see PHO’s At A Glance: Myocarditis and Pericarditis Following COVID-19 mRNA Vaccines for more information on this topic.

Table 3. Characteristics of myocarditis or pericarditis reports received to date following COVID-19 mRNA vaccines: Ontario, December 13, 2020 to July 31, 2021

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Note: Fifteen reports with unknown time to onset and one report with 54 days to onset have been excluded from the calculation of median time to onset and range.

Serious AEFIs


In Ontario, AEFIs that meet the serious definition are events that required hospital admission and reports of death (see the technical notes for a full definition). There were 488 AEFI reports classified as serious, representing 5.0% of all AEFI reports and a serious AEFI reporting rate of 2.5 per 100,000 doses administered for all vaccine products combined. As a comparison, the proportion of AEFIs defined as serious for all vaccines administered in Ontario ranged from 2.8% and 5.0% between 2012 and 2018.16 The serious reporting rate was 1.8 and 3.0 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rate for the AstraZeneca/COVISHIELD vaccine was 8.8 per 100,000 doses administered.

AEFI REPORTS REQUIRING HOSPITALIZATION

AEFI REPORTS REQUIRING HOSPITALIZATION Of the 488 reports meeting the serious definition, 482 reports had a hospital admission related to the reported events. Table 4 summarizes the outcome of the 482 reports at the time of reporting and the event that was the prominent reason for hospitalization.

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lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
24,722
荣誉分数
6,118
声望点数
373
12月13日至8月7日,总接种将近19.5 millions,共536例严重不良反应,10万分之2.7。其中每十万剂疫苗发生严重不良反应:辉瑞2,Moderna: 3.3, AZ:9.1。大约70.5%的不良反应由第一针引发,18.1%与第二针有关。

536位严重不良反应患者中有530位住院治疗,在提交报告时,184位病人已经康复出院,242位仍在治疗,总结报告见表4。

阿斯利康疫苗共发生21例血小板减少症(TTS),与上周报告无变化。2.4 / 10万 = 1 / 41000,其中16例确诊由疫苗诱导的免疫性血小板减少症(VITT),1.9 / 10万 = 1 / 54000, 5例确诊与疫苗无关。一例VITT患者死亡报告,死因正在调查,尚未确定。

截止8月7日,安大略省已收到 246 例在接受 COVID19 mRNA 疫苗后出现心肌炎或心包炎的报告,比上周增加31例。其中150例,占61%,需要住院治疗。辉瑞127例,莫德纳119,188例男性,58例女性,男性占76%。年龄范围在 12 至 81 岁之间(中位数为 24 岁); 症状多发生于青少年和轻年男性(18 - 24岁),更常见于第二针后一周之内,通常在4 - 5天。比率为11.3/million mRNA 疫苗;最高比率出现在接种第二针的18-24岁男性,150/million。

共有33人死亡暂时可能与疫苗相关,其中5人是老人院成员。4例死亡与严重不良反应有关,其中3例主要由其他基础病引起,一例为疫苗诱发血小板减少性血栓造成。

Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to August 7, 2021

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Figure 1. Number of AEFI reports and doses administered by week of COVID-19 vaccine administration: Ontario, December 13, 2020 to August 7, 2021

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Note: AEFI reports are assessed based on date of vaccine administration. The administration week ranges from week 51 (Dec 13 to 19, 2020) to week 31 (August 1 – 7, 2021). The number of AEFI reports for the recent reporting weeks are subject to reporting delays and/or delayed data entry (i.e., reports are likely to be still under investigation and yet to be reported as a confirmed AEFI report). Data corrections or updates can result in AEFI reports being removed and/or updated from past reports and may result in counts differing from past publicly reported AEFIs.

VACCINE-INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA (VITT) AND THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (TTS) Thrombosis with Thrombocytopenia Syndrome (TTS)

Same as before.

MYOCARDITIS/PERICARDITIS

There have been international reports, including from the United States and Israel, of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with COVID-19 mRNA vaccines.11,12 Information to date indicates that these events occur more commonly after the second dose, within the week following vaccination (typically within 4-5 days), mainly in adolescents/young adults and more often in males than females.

PHAC and Health Canada are closely monitoring these events in passive and active Canadian vaccine safety surveillance systems.

As of August 7, 2021, there have been 246 reports of myocarditis or pericarditis following receipt of COVID-19 mRNA vaccines in Ontario. These reports have been identified through case-level review of all reported AEFIs. Of these, 70 (28.5%) were diagnosed with myocarditis and 100 (40.7%) were diagnosed with pericarditis. The remaining 76 were diagnosed with perimyocarditis (n=11), myopericarditis (n=64) or inflammatory cardiac reaction of unclear significance (n=1). The 70 reports of myocarditis have been assessed using the Brighton Collaboration case definition for myocarditis; 65 reports met Brighton levels of diagnostic certainty 1, 2 or 3 (92.9%), three reports had insufficient evidence to meet level 1, 2 or 3 of the case definition (4.3%) and two reports did not meet the Brighton Collaboration case definition for myocarditis (2.9%). 14 Of the 100 reports of pericarditis assessed using the Brighton Collaboration case definition for pericarditis, 54 reports met Brighton levels of diagnostic certainty 1, 2 or 3 (54.0%), 37 reports had insufficient evidence to meet level 1, 2 or 3 of the case definition (37.0%), and seven reports did not meet the Brighton Collaboration case definition for pericarditis (7.0%). 14 Two reports could not be assessed due to lack of information. See Table 3 for further characteristics of myocarditis/pericarditis reports.

Of the 246 reports of myocarditis or pericarditis, 150 (61.0%) reports had a hospital admission with some variation by age group. Among the 128 reports where both the date of admission and discharge was available for review, the median length of stay was two days.


Based on 246 reports of myocarditis or pericarditis, the overall crude reporting rate is 13.1 per million doses of mRNA vaccines administered. The highest reporting rates were observed in younger age groups (12-17 and 18-24 years) and among males. The highest reporting rate was observed for males aged 18- 24 years of age following dose 2, at 149.5 events per million doses administered. Table A3 in Appendix A presents the reporting rate of myocarditis or pericarditis by age group, gender and dose number. The reporting rates are calculated by including all reports of myocarditis or pericarditis identified through case-level review, regardless of whether they meet the Brighton Collaboration case definition for myocarditis or pericarditis.

Additionally, there are 66 reports classified as ‘persons under investigation’ as public health units are still collecting additional information on the AEFI report. Ontario is continuing to monitor these events in collaboration with its partners and weekly updates can be found within this report and on the PHAC website. Please see PHO’s At A Glance: Myocarditis and Pericarditis Following COVID-19 mRNA Vaccines for more information on this topic.


Table 3. Characteristics of myocarditis or pericarditis reports received to date following COVID-19 mRNA vaccines: Ontario, December 13, 2020 to August 7, 2021

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Note: Eighteen reports with unknown time to onset and one report with 54 days to onset have been excluded from the calculation of median time to onset and range.


Serious AEFIs

In Ontario, AEFIs that meet the serious definition are events that required hospital admission and reports of death (see the technical notes for a full definition). There were 536 AEFI reports classified as serious, representing 5.2% of all AEFI reports and a serious AEFI reporting rate of 2.7 per 100,000 doses administered for all vaccine products combined. As a comparison, the proportion of AEFIs defined as serious for all vaccines administered in Ontario ranged from 2.8% and 5.0% between 2012 and 2018.16 The serious reporting rate was 2.0 and 3.3 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rate for the AstraZeneca/COVISHIELD vaccine was 9.1 per 100,000 doses administered.

AEFI REPORTS REQUIRING HOSPITALIZATION

Of the 536 reports meeting the serious definition, 530 reports had a hospital admission related to the reported events. Table 4 summarizes the outcome of the 530 reports at the time of reporting and the event that was the prominent reason for hospitalization.

Table 4. Summary of outcomes and events for AEFI reports requiring hospitalization: Ontario, December 13, 2020 to August 7, 2021

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AEFI REPORTS WITH FATAL OUTCOME

The remaining six serious AEFIs were reports of death following receipt of COVID-19 vaccine that met the provincial surveillance definition (i.e., other severe/unusual event) as follows:

 Resident of a health-care institution with significant co-morbidities. The cause of death was not attributed to the vaccine.
 Community dwelling senior with complex cardiovascular and renal conditions, wherein the AEFI may have contributed to but was not the underlying cause of death.
 Community dwelling senior with multiple comorbidities including heart disease and an autoimmune disorder. The cause of death was not attributed to the vaccine.
 An individual with VITT with death recorded in CCM (described above under Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) and Thrombosis with Thrombocytopenia Syndrome (TTS)).
 Individual with hypertension, wherein the cause of death was not clearly attributed to vaccine.
 Community dwelling senior with a complex cardiovascular history. The AEFI may have contributed to but was not the underlying cause of death.


Reports of death temporally associated with receipt of vaccine

In Ontario, all deaths temporally associated with receipt of vaccines that have been reported to public health units are thoroughly investigated and reported to PHO. As of August 7, 2021, there are 33 reports of deaths temporally associated with receipt of COVID-19 vaccine that are currently classified as ‘persons under investigation’ as they do not currently meet the provincial surveillance definition. These investigations are ongoing and additional information including a cause of death (e.g., autopsy or Coroner’s report) is expected. Preliminary information suggests that these events occurred in individuals with multiple co-morbidities which may be related to the cause of death. Five of the 33 reports are in long-term care home (LTCH)/retirement home residents. There has been no association with vaccine identified at this time. Reports of death that meet the provincial case definition are events temporally associated with vaccine that have not been clearly attributed to other causes; these reports should not be interpreted as causally related with vaccine.

During the first few months of the COVID-19 vaccination campaign, LTCH/retirement home residents have been a focus for vaccination efforts. In this population, it was expected that deaths may occur close to the time of vaccination and require further evaluation to determine the cause of death. After reviewing reports of deaths of very frail elderly individuals vaccinated with Pfizer-BioNTech COVID-19 vaccine, the Global Advisory Committee on Vaccine Safety (GACVC) COVID-19 Vaccine Safety subcommittee concluded that “the current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of Pfizer-BioNTech COVID-19 vaccine”. The Centres for Disease Control (CDC) also presented a similar assessment of their analysis at the January 27, 2021 meeting of the Advisory Committee on Immunization Practices (ACIP) in the United States that mortality in LTCH residents is high and substantial numbers of deaths in this population are expected, unrelated to vaccination. PHO continues to conduct continuous monitoring of the safety of COVID-19 vaccines in collaboration with its partners, including individual case review of all serious AEFIs including reports of death temporally association with receipt of vaccine, daily analysis of surveillance data for vaccine safety signals and weekly reporting on the PHO website and to the Public Health Agency of Canada.
 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
24,722
荣誉分数
6,118
声望点数
373
12月13日至8月14日,总接种20 millions,共567例严重不良反应,10万分之2.8。其中每十万剂疫苗发生严重不良反应:辉瑞2.1,Moderna: 3.5, AZ:9.4。大约70%的不良反应由第一针引发,19%与第二针有关。

567位严重不良反应患者中有561位住院治疗,在提交报告时,198位病人已经康复出院,258位仍在治疗,总结报告见表4。

阿斯利康疫苗共发生21例血小板减少症(TTS),与上周报告无变化。2.4 / 10万 = 1 / 41000,其中16例确诊由疫苗诱导的免疫性血小板减少症(VITT),1.9 / 10万 = 1 / 54000, 5例确诊与疫苗无关。一例VITT患者死亡报告,死因正在调查,尚未确定。

截止8月14日,安大略省已收到 272 例在接受 COVID19 mRNA 疫苗后出现心肌炎或心包炎的报告,比上周增加26例。其中157例,占57.7%,需要住院治疗。辉瑞146例,莫德纳126,206例男性,66例女性,男性占76%。年龄范围在 12 至 81 岁之间(中位数为 24 岁); 症状多发生于青少年和轻年男性(18 - 24岁),更常见于第二针后一周之内,通常在4 - 5天。比率为14.3/million mRNA 疫苗;最高比率出现在接种第二针的18-24岁男性,147.7/million。

共有33人死亡暂时可能与疫苗相关,其中5人是老人院成员。4例死亡与严重不良反应有关,其中3例主要由其他基础病引起,一例为疫苗诱发血小板减少性血栓造成。

1629491276687.png


Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to August 14, 2021

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Table 2. Summary of all AEFI reports received to date by age group and gender: Ontario, December 13, 2020 to August 14, 2021

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Figure 1. Number of AEFI reports and doses administered by week of COVID-19 vaccine administration: Ontario, December 13, 2020 to August 14, 2021

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Note: AEFI reports are assessed based on date of vaccine administration. The administration week ranges from week 51 (Dec 13 to 19, 2020) to week 32 (August 8 – 14, 2021). The number of AEFI reports for the recent reporting weeks are subject to reporting delays and/or delayed data entry (i.e., reports are likely to be still under investigation and yet to be reported as a confirmed AEFI report). Data corrections or updates can result in AEFI reports being removed and/or updated from past reports and may result in counts differing from past publicly reported AEFIs.

MYOCARDITIS/PERICARDITIS

There have been international reports, including from the United States and Israel, of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with COVID-19 mRNA vaccines.11,12 Information to date indicates that these events occur more commonly after the second dose, within the week following vaccination (typically within 4-5 days), mainly in adolescents/young adults and more often in males than females.

PHAC and Health Canada are closely monitoring these events in passive and active Canadian vaccine safety surveillance systems.

As of August 14, 2021, there have been 272 reports of myocarditis or pericarditis following receipt of COVID-19 mRNA vaccines in Ontario. These reports have been identified through case-level review of all reported AEFIs. Of these, 74 (27.2%) were diagnosed with myocarditis and 116 (42.7%) were diagnosed with pericarditis. The remaining 82 were diagnosed with perimyocarditis (n=12), myopericarditis (n=65), myocarditis/pericarditis (n=3), pleuropericarditis (n=1) or inflammatory cardiac reaction of unclear significance (n=1). The 74 reports of myocarditis have been assessed using the Brighton Collaboration case definition for myocarditis; 68 reports met Brighton levels of diagnostic certainty 1, 2 or 3 (91.9%), three reports had insufficient evidence to meet level 1, 2 or 3 of the case definition (4.1%), two reports did not meet the Brighton Collaboration case definition for myocarditis (2.7%), and one report was not yet assessed. 14 Of the 116 reports of pericarditis assessed using the Brighton Collaboration case definition for pericarditis, 60 reports met Brighton levels of diagnostic certainty 1, 2 or 3 (51.7%), 42 reports had insufficient evidence to meet level 1, 2 or 3 of the case definition (36.2%), and 11 reports did not meet the Brighton Collaboration case definition for pericarditis (9.5%). 14 Three reports could not be assessed due to lack of information. See Table 3 for further characteristics of myocarditis/pericarditis reports. The remaining 82 reports were assessed against both Brighton Collaboration case definition for myocarditis and pericarditis to see if they meet either one of two definitions; of these, 73 (89.0%) met Brighton levels of diagnostic certainty 1, 2 or 3 for either myocarditis or pericarditis.

Of the 272 reports of myocarditis or pericarditis, 157 (57.7%) reports had a hospital admission with some variation by age group. Among the 135 reports where both the date of admission and discharge was available for review, the median length of stay was two days.

Based on 272 reports of myocarditis or pericarditis, the overall crude reporting rate is 14.3 per million doses of mRNA vaccines administered. The highest reporting rates were observed in younger age groups (12-17 and 18-24 years) and among males. The highest reporting rate was observed for males aged 18- 24 years of age following dose 2, at 147.7 events per million doses administered. Table A3 in Appendix A presents the reporting rate of myocarditis or pericarditis by age group, gender and dose number. The reporting rates are calculated by including all reports of myocarditis or pericarditis identified through case-level review, regardless of whether they meet the Brighton Collaboration case definition for myocarditis or pericarditis.

Additionally, there are 75 reports classified as ‘persons under investigation’ as public health units are still collecting additional information on the AEFI report. Ontario is continuing to monitor these events in collaboration with its partners and weekly updates can be found within this report and on the PHAC website. Please see PHO’s At A Glance: Myocarditis and Pericarditis Following COVID-19 mRNA Vaccines for more information on this topic.15


Table 3. Characteristics of myocarditis or pericarditis reports received to date following COVID-19 mRNA vaccines: Ontario, December 13, 2020 to August 14, 2021

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Note: Twenty-one reports with unknown time to onset and two reports with time to onset of greater than 42 days have been excluded from the calculation of median time to onset and range.


AEFIs

In Ontario, AEFIs that meet the serious definition are events that required hospital admission and reports of death (see the technical notes for a full definition). There were 567 AEFI reports classified as serious, representing 5.2% of all AEFI reports and a serious AEFI reporting rate of 2.8 per 100,000 doses administered for all vaccine products combined. As a comparison, the proportion of AEFIs defined as serious for all vaccines administered in Ontario ranged from 2.8% and 5.0% between 2012 and 2018.16 The serious reporting rate was 2.1 and 3.5 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rate for the AstraZeneca/COVISHIELD vaccine was 9.4 per 100,000 doses administered.

AEFI REPORTS REQUIRING HOSPITALIZATION

Of the 567 reports meeting the serious definition, 561 reports had a hospital admission related to the reported events. Table 4 summarizes the outcome of the 561 reports at the time of reporting and the event that was the prominent reason for hospitalization.

Table 4. Summary of outcomes and events for AEFI reports requiring hospitalization: Ontario, December 13, 2020 to August 14, 2021

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AEFI REPORTS WITH FATAL OUTCOME

The remaining six serious AEFIs were reports of death following receipt of COVID-19 vaccine that met the provincial surveillance definition (i.e., other severe/unusual event) as follows:
 Resident of a health-care institution with significant co-morbidities. The cause of death was not attributed to the vaccine.
 Community dwelling senior with complex cardiovascular and renal conditions, wherein the AEFI may have contributed to but was not the underlying cause of death.
 Community dwelling senior with multiple comorbidities including heart disease and an autoimmune disorder. The cause of death was not attributed to the vaccine.
 An individual with VITT with death recorded in CCM (described above under Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) and Thrombosis with Thrombocytopenia Syndrome (TTS)).
 Individual with hypertension, wherein the cause of death was not clearly attributed to vaccine.
 Community dwelling senior with a complex cardiovascular history. The AEFI may have contributed to but was not the underlying cause of death.


Reports of death temporally associated with receipt of vaccine

In Ontario, all deaths temporally associated with receipt of vaccines that have been reported to public health units are thoroughly investigated and reported to PHO. As of August 14, 2021, there are 33 reports of deaths temporally associated with receipt of COVID-19 vaccine that are currently classified as ‘persons under investigation’ as they do not currently meet the provincial surveillance definition. These investigations are ongoing and additional information including a cause of death (e.g., autopsy or Coroner’s report) is expected. Preliminary information suggests that these events occurred in individuals with multiple co-morbidities which may be related to the cause of death. Five of the 33 reports are in long-term care home (LTCH)/retirement home residents. There has been no association with vaccine identified at this time. Reports of death that meet the provincial case definition are events temporally associated with vaccine that have not been clearly attributed to other causes; these reports should not be interpreted as causally related with vaccine.

During the first few months of the COVID-19 vaccination campaign, LTCH/retirement home residents have been a focus for vaccination efforts. In this population, it was expected that deaths may occur close to the time of vaccination and require further evaluation to determine the cause of death. After reviewing reports of deaths of very frail elderly individuals vaccinated with Pfizer-BioNTech COVID-19 vaccine, the Global Advisory Committee on Vaccine Safety (GACVC) COVID-19 Vaccine Safety subcommittee concluded that “the current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of Pfizer-BioNTech COVID-19 vaccine”.17 The Centres for Disease Control (CDC) also presented a similar assessment of their analysis at the January 27, 2021 meeting of the Advisory Committee on Immunization Practices (ACIP) in the United States that mortality in LTCH residents is high and substantial numbers of deaths in this population are expected, unrelated to vaccination.18 PHO continues to conduct continuous monitoring of the safety of COVID-19 vaccines in collaboration with its partners, including individual case review of all serious AEFIs including reports of death temporally association with receipt of vaccine, daily analysis of surveillance data for vaccine safety signals and weekly reporting on the PHO website and to the Public Health Agency of Canada.
 
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12月13日至8月21日,总接种20.4 millions,共601例严重不良反应,10万分之2.9。其中每十万剂疫苗发生严重不良反应:辉瑞2.2,Moderna: 3.6, AZ:9.7。大约69%的不良反应由第一针引发,20%与第二针有关。

601位严重不良反应患者中有595位住院治疗,在提交报告时,207位病人已经康复出院,275位仍在治疗,总结报告见表4。

阿斯利康疫苗共发生21例血小板减少症(TTS),与上周报告无变化。2.4 / 10万 = 1 / 41000,其中16例确诊由疫苗诱导的免疫性血小板减少症(VITT),1.9 / 10万 = 1 / 54000, 5例确诊与疫苗无关。一例VITT患者死亡报告,死因正在调查,尚未确定。

截止8月21日,安大略省已收到 307 例在接受 COVID19 mRNA 疫苗后出现心肌炎或心包炎的报告,比上周增加35例。其中174例,占56.7%,需要住院治疗。辉瑞165例,莫德纳142,230例男性,77例女性,男性占75%。年龄范围在 12 至 81 岁之间(中位数为 24 岁); 症状多发生于青少年和轻年男性(18 - 24岁),更常见于第二针后一周之内,通常在4 - 5天。比率为15.9/million mRNA 疫苗;最高比率出现在接种第二针的18-24岁男性,164.2/million。

共有33人死亡暂时可能与疫苗相关,其中5人是老人院成员。4例死亡与严重不良反应有关,其中3例主要由其他基础病引起,一例为疫苗诱发血小板减少性血栓造成。

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Adverse Events Following Immunization (AEFIs) for COVID-19 in Ontario: December 13, 2020 to August 21, 2021

1630100948573.png


Summary of AEFI reports in Ontario

An AEFI report refers to a report received by the PHU, which pertains to one individual vaccine recipient who reported at least one adverse event after receiving the COVID-19 vaccine (i.e., temporally associated with the vaccine).

See Table 1 for a summary of all AEFI reports received to date in Ontario. Of the total number of AEFI reports, 69.4% are reported to be associated with the first dose of COVID-19 vaccination (using the information from CCM) whereas 19.7% are reported to be associated with the second dose. The remaining reports have unknown or missing dose number in CCM.


Table 1. Summary of all AEFI reports received to date by COVID-19 vaccine: Ontario, December 13, 2020 to August 21, 2021

1630105908378.png

Note: Five AEFI reports did not specify vaccine product received. Data corrections or updates can result in AEFI reports being removed and/or updated from past reports and may result in counts differing from past publicly reported AEFIs

Table 2. Summary of all AEFI reports received to date by age group and gender: Ontario, December 13, 2020 to August 21, 2021
1630106106644.png

Note: Age represents age at time of immunization. Sex was used when gender was missing. Some AEFI reports and doses administered records have unknown gender or age; these reports are excluded from gender and age-specific counts and reporting rate. Data corrections or updates can result in AEFI reports being removed and/or updated from past reports and may result in counts differing from past publicly reported AEFIs.

Figure 1. Number of AEFI reports and doses administered by week of COVID-19 vaccine administration: Ontario, December 13, 2020 to August 21, 2021
1630106339853.png

Note: AEFI reports are assessed based on date of vaccine administration. The administration week ranges from week 51 (Dec 13 to 19, 2020) to week 33 (August 15 – 21, 2021). The number of AEFI reports for the recent reporting weeks are subject to reporting delays and/or delayed data entry (i.e., reports are likely to be still under investigation and yet to be reported as a confirmed AEFI report). Data corrections or updates can result in AEFI reports being removed and/or updated from past reports and may result in counts differing from past publicly reported AEFIs.

MYOCARDITIS/PERICARDITIS

There have been international reports, including from the United States and Israel, of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) following vaccination with COVID-19 mRNA vaccines.11,12 Information to date indicates that these events occur more commonly after the second dose, within the week following vaccination (typically within 4-5 days), mainly in adolescents/young adults and more often in males than females.

PHAC and Health Canada are closely monitoring these events in passive and active Canadian vaccine safety surveillance systems.5

As of August 21, 2021, there have been 307 reports of myocarditis or pericarditis following receipt of COVID-19 mRNA vaccines in Ontario. These reports have been identified through case-level review of all reported AEFIs. Of these, 81 (26.4%) were diagnosed with myocarditis and 130 (42.3%) were diagnosed with pericarditis. The remaining 96 (31.3%) were diagnosed with perimyocarditis (n=15), myopericarditis (n=77), myocarditis/pericarditis (n=3) and pleuropericarditis (n=1). The 81 reports of myocarditis have been assessed using the Brighton Collaboration case definition for myocarditis; 74 reports met Brighton levels of diagnostic certainty 1, 2 or 3 (91.4%), two reports had insufficient evidence to meet level 1, 2 or 3 of the case definition (2.5%) and one report did not meet the Brighton Collaboration case definition for myocarditis (1.2%). 14 Four reports could not be assessed due to lack of information. Of the 130 reports of pericarditis assessed using the Brighton Collaboration case definition for pericarditis, 63 reports met Brighton levels of diagnostic certainty 1, 2 or 3 (48.5%), 47 reports had insufficient evidence to meet level 1, 2 or 3 of the case definition (36.2%), and 14 reports did not meet the Brighton Collaboration case definition for pericarditis (10.8%). 14 Six reports could not be assessed due to lack of information. See Table 3 for further characteristics of myocarditis/pericarditis reports. The remaining 96 reports were assessed against both Brighton Collaboration case definition for myocarditis and pericarditis to see if they meet either one of two definitions; of these, 82 (85.4%) met Brighton levels of diagnostic certainty 1, 2 or 3 for either myocarditis or pericarditis.

Of the 307 reports of myocarditis or pericarditis, 174 (56.7%) reports had a hospital admission with some variation by age group. Among the 147 reports where both the date of admission and discharge was available for review, the median length of stay was two days.

Based on 307 reports of myocarditis or pericarditis, the overall crude reporting rate is 15.9 per million doses of mRNA vaccines administered. The highest reporting rates were observed in younger age groups (12-17 and 18-24 years) and among males. The highest reporting rate was observed for males aged 18- 24 years of age following dose 2, at 164.2 events per million doses administered. Table A3 in Appendix A presents the reporting rate of myocarditis or pericarditis by age group, gender and dose number. The reporting rates are calculated by including all reports of myocarditis or pericarditis identified through case-level review, regardless of whether they meet the Brighton Collaboration case definition for myocarditis or pericarditis.

Additionally, there are 67 reports classified as ‘persons under investigation’ as public health units are still collecting additional information on the AEFI report. Ontario is continuing to monitor these events in collaboration with its partners and weekly updates can be found within this report and on the PHAC website. Please see PHO’s At A Glance: Myocarditis and Pericarditis Following COVID-19 mRNA Vaccines for more information on this topic.

Table 3. Characteristics of myocarditis or pericarditis reports received to date following COVID-19 mRNA vaccines: Ontario, December 13, 2020 to August 21, 2021
1630106697965.png

Note: Thirty reports with unknown time to onset and two reports with time to onset of greater than 42 days have been excluded from the calculation of median time to onset and range.

Serious AEFIs

In Ontario, AEFIs that meet the serious definition are events that required hospital admission and reports of death (see the technical notes for a full definition). There were 601 AEFI reports classified as serious, representing 5.3% of all AEFI reports and a serious AEFI reporting rate of 2.9 per 100,000 doses administered for all vaccine products combined. As a comparison, the proportion of AEFIs defined as serious for all vaccines administered in Ontario ranged from 2.8% and 5.0% between 2012 and 2018.16 The serious reporting rate was 2.2 and 3.6 per 100,000 doses administered for the Pfizer-BioNTech vaccine and the Moderna vaccine, respectively. The serious reporting rate for the AstraZeneca/COVISHIELD vaccine was 9.7 per 100,000 doses administered.

AEFI REPORTS REQUIRING HOSPITALIZATION

Of the 601 reports meeting the serious definition, 595 reports had a hospital admission related to the reported events. Table 4 summarizes the outcome of the 595 reports at the time of reporting and the event that was the prominent reason for hospitalization.


Table 4. Summary of outcomes and events for AEFI reports requiring hospitalization: Ontario, December 13, 2020 to August 21, 2021

1630106984869.png

Note: * an outcome reported as “residual effects” is defined as residual disability or sequelae related to the reported event. Due to the relatively short follow-up time for AEFIs reported in CCM, it is uncertain whether these residual effects will resolve, but had not yet resolved at the time of reporting.


AEFI REPORTS WITH FATAL OUTCOME

The remaining six serious AEFIs were reports of death following receipt of COVID-19 vaccine that met the provincial surveillance definition (i.e., other severe/unusual event) as follows:
 Resident of a health-care institution with significant co-morbidities. The cause of death was not attributed to the vaccine.
 Community dwelling senior with complex cardiovascular and renal conditions, wherein the AEFI may have contributed to but was not the underlying cause of death.
 Community dwelling senior with multiple comorbidities including heart disease and an autoimmune disorder. The cause of death was not attributed to the vaccine.
 An individual with VITT with death recorded in CCM (described above under Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) and Thrombosis with Thrombocytopenia Syndrome (TTS)).
 Individual with hypertension, wherein the cause of death was not clearly attributed to vaccine.
 Community dwelling senior with a complex cardiovascular history. The AEFI may have contributed to but was not the underlying cause of death.


Reports of death temporally associated with receipt of vaccine


In Ontario, all deaths temporally associated with receipt of vaccines that have been reported to public health units are thoroughly investigated and reported to PHO. As of August 21, 2021, there are 33 reports of deaths temporally associated with receipt of COVID-19 vaccine that are currently classified as ‘persons under investigation’ as they do not currently meet the provincial surveillance definition. These investigations are ongoing and additional information including a cause of death (e.g., autopsy or Coroner’s report) is expected. Preliminary information suggests that these events occurred in individuals with multiple co-morbidities which may be related to the cause of death. Five of the 33 reports are in long-term care home (LTCH)/retirement home residents. There has been no association with vaccine identified at this time. Reports of death that meet the provincial case definition are events temporally associated with vaccine that have not been clearly attributed to other causes; these reports should not be interpreted as causally related with vaccine.

During the first few months of the COVID-19 vaccination campaign, LTCH/retirement home residents have been a focus for vaccination efforts. In this population, it was expected that deaths may occur close to the time of vaccination and require further evaluation to determine the cause of death. After reviewing reports of deaths of very frail elderly individuals vaccinated with Pfizer-BioNTech COVID-19 vaccine, the Global Advisory Committee on Vaccine Safety (GACVC) COVID-19 Vaccine Safety subcommittee concluded that “the current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of Pfizer-BioNTech COVID-19 vaccine”.17 The Centres for Disease Control (CDC) also presented a similar assessment of their analysis at the January 27, 2021 meeting of the Advisory Committee on Immunization Practices (ACIP) in the United States that mortality in LTCH residents is high and substantial numbers of deaths in this population are expected, unrelated to vaccination.18 PHO continues to conduct continuous monitoring of the safety of COVID-19 vaccines in collaboration with its partners, including individual case review of all serious AEFIs including reports of death temporally association with receipt of vaccine, daily analysis of surveillance data for vaccine safety signals and weekly reporting on the PHO website and to the Public Health Agency of Canada.
 

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