全球领先疫苗,39支疫苗进入3期实验,10月13日,德国法国放弃两款mRNA疫苗,转为研发新一代疫苗和加强剂。中国两款疫苗进入第三期试验。

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,499
荣誉分数
6,638
声望点数
373
32 min ago

Novavax says UK Phase 3 trial shows its coronavirus vaccine has 89% efficacy​

From CNN's Jacqueline Howard

A Phase 3 trial of biotechnology company Novavax’s Covid-19 vaccine shows it has an efficacy of 89.3%, the company announced on Thursday.

But the company highlighted the vaccine’s apparent efficacy against new variants of the virus that have alarmed politicians and scientists alike.

The trial, conducted in the United Kingdom, included efficacy estimates by strain based on PCR tests performed on strains from 56 Covid-19 cases in the trial. The vaccine was found to have 95.6% efficacy against the original novel coronavirus and 85.6% against the variant first identified in the UK, known as B.1.1.7.

The company also announced that a Phase 2b study conducted in South Africa, where another variant was first identified, showed 60% efficacy.

"With today’s results from our UK Phase 3 and South Africa Phase 2b clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2 and 3 trials involving over 20,000 participants," Stanley Erck, Novavax president and CEO, said in the announcement.

The company's vaccine, known as NVX-CoV2373, “is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants,” Erck said. “NVX-CoV2373 has the potential to play an important role in solving this global public health crisis."

Regarding the trial in South Africa, “the 60% reduced risk against COVID-19 illness in vaccinated individuals in South Africans underscores the value of this vaccine to prevent illness from the highly worrisome variant currently circulating in South Africa, and which is spreading globally,” Shabir Maddi, principal investigator in the Novavax Covid-19 vaccine trial in South Africa, said in the announcement.

"This is the first COVID-19 vaccine for which we now have objective evidence that it protects against the variant dominating in South Africa,” Maddi said.
 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,499
荣誉分数
6,638
声望点数
373
42 min ago

Biden "encouraged" by Johnson & Johnson Covid-19 vaccine news, White House says​

From CNN's Betsy Klein

Nicholas Kamm/AFP via Getty Images
Nicholas Kamm/AFP via Getty Images

President Joe Biden is “encouraged” about Johnson & Johnson’s single-shot Covid-19 vaccine news.

“The President is encouraged by positive data on a potential new vaccine. He also knows that this is must new data and now is the time for the FDA to do its job of evaluating the safety and efficacy of the vaccine,” White House press secretary Jen Psaki said as she began Friday’s press briefing.

Johnson & Johnson’s vaccine was shown to be 66% effective in preventing moderate and severe disease in a global Phase 3 trial, but 85% effective against severe disease. The company plans to submit an application to the US Food and Drug Administration for emergency use authorization for the vaccine next week.

In the meantime, Psaki said, Biden continues to urge Americans to mask up and follow public health guidelines “until it’s their turn to get vaccinated.”

She declined to “get ahead of the experts” who will brief virtually at 11:00 am and will discuss the new vaccine news further.

2 hr 34 min ago

Johnson & Johnson official praises company's Covid-19 vaccine: "This vaccine is for everyone"​

From CNN's Jacqueline Howard

Johnson & Johnson officials praised their vaccine's 85% efficacy against severe Covid-19 during a phone call with reporters on Friday morning. The call was held along with officials from the National Institutes of Health.

"Our topline result is that we have 85% protection against disease that matters – disease that causes people to feel particularly ill at home, and results in seeking medical attention after that," Dr. Mathai Mammen, Janssen’s global head of research and development, said during the call. Janssen is the vaccine arm of Johnson & Johnson.

"We have really good efficacy, same level of protection, across all age groups, from the very young to the middle age to the very old. We have the same efficacy across race and ethnicity," Mammen said. "This vaccine is for everyone."

Johnson & Johnson’s single-shot Covid-19 vaccine was shown to be 66% effective in preventing moderate and severe disease in a global Phase 3 trial, but 85% effective against severe disease, the company announced Friday.

The vaccine was 72% effective against moderate and severe disease in the US, the company said.
 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,499
荣誉分数
6,638
声望点数
373
4 hr 43 min ago

German officials expect EU approval on AstraZeneca vaccine without age restrictions, despite advice on over 65s​

From CNN's Nadine Schmidt and Claudia Otto

Klaus Cichutek, President of the Paul Ehrlich Institute, addresses a press conference in Berlin, Germany, on January 29.
Klaus Cichutek, President of the Paul Ehrlich Institute, addresses a press conference in Berlin, Germany, on January 29. Hannibal Hanschke/Pool/AFP/Getty Images

German officials expect the EU's medicines regulator, The European Medicines Agency (EMA) to approve AstraZeneca’s coronavirus vaccine without age restrictions, despite a previous German recommendation that the vaccine should not be given to people over the age of 65.

“The essential bases have been created for a recommendation for approval without age limit,” Klaus Cichutek, the head of Germany's vaccine regulator said during a briefing in Berlin, cautioning that data is weaker on the vaccine’s effects on older age groups.

Cichutek’s remarks come just a day after Germany's vaccine commission said it recommended that the vaccine developed by AstraZeneca and the University of Oxford should not be given to people aged over 65 years old due to insufficient data.

According to Germany’s Interior Ministry, Germany’s own vaccine commission, STIKO, found there is insufficient data on the “effectiveness of the AstraZeneca vaccine in people over 65 years of age.”

While the European Medicines Agency (EMA) is expected to issue its approval without restrictions, this will likely not be the case for the German vaccine commission STIKO.

“We do not expect unrestricted approval [in Germany],” Health Minister Jens Spahn said Friday during the same briefing.
“There is not sufficient data for that. There is not sufficient data for the elderly,” he added.

Spahn added that the AstraZeneca vaccine may not be authorized in Germany for use in people aged over 65, but the government is still aiming to vaccinate all people over the age of 80 by the end of the first quarter of 2021.

So far, Germany has administered the coronavirus vaccines developed by Pfizer/BioNTech and Moderna.

Some background:

As of Friday, according to Germany's health agency the Robert Koch Institute (RKI), 3.5 million coronavirus vaccines have been distributed across the country with 2.4 million vaccinations administered.

But as the EU experiences a vaccine shortfall, Spahn warned Germany too should expect "some weeks" of shortages.

RKI head Lothar Wieler told journalists on Friday that although Germany is “on a good path,” with infection numbers declining, more cases of new coronavirus variants are being confirmed, putting increased pressure on the country’s hospitals.

According to RKI, 14,022 new coronavirus cases have been confirmed in Germany as of Friday, bringing the country’s total number of cases reported since the beginning of the pandemic to 2,192,850.
 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,499
荣誉分数
6,638
声望点数
373

美国65岁的议员接种两针辉瑞疫苗之后确诊感染。议员在1月20日参加总统宣誓就职仪式当天测试阴性,并接种了第二针疫苗。9天以后,1月29日测试阳性。

辉瑞疫苗试验结果表明,95%有效率。这位议员不幸落入5%的范围。但是无症状,疫苗可能起到保护作用,防治病情恶化。现在对于病人是否具有传染性还没有明确的结论。

Dr. Marc Siegel: Congressman tests positive after COVID vaccine – here's what this case tells us​

Does this represent a vaccine failure?​

By Dr. Marc Siegel | Fox News

Rep. Lynch tests positive for coronavirus after receiving both COVID-19 vaccine doses

Dr. Marc Siegel discusses why the congressman may have contracted the virus despite being vaccinated.

Rep. Stephen Lynch, D-Mass., has tested positive for coronavirus – after receiving both doses of Pfizer's vaccine.

Lynch is 65 years old. He does not appear to be overweight but his age alone puts him in a group where he is at risk for complications of COVID-19. The Centers for Disease Control and Prevention now recommends that everyone over the age of 65 be a priority to be vaccinated.

Lynch would be in that group even if he weren’t a congressman. It was appropriate for him to receive the Pfizer/BioNTech COVID-19 when he did.

He attended President Biden’s inauguration after a negative COVID test, but on Jan. 29, nine days after receiving the second dose, he tested positive for COVID-19 after being exposed to a staff member in his office who tested positive earlier in the week. Lynch is asymptomatic and is isolating himself.

Does this represent a vaccine failure? Is the congressman in the 5% group that are not successfully immunized against COVID by the Pfizer vaccine? As long as he remains symptom-free the answer is most likely not. He probably picked up the virus from his staffer and it is in his nose, causing a positive test. But the vaccine is protecting him from getting sick, which is what we are hoping it will do.

The question remains how contagious he is. How much virus does he have? This is known as viral load. Is he less likely to transmit the virus to others because of the vaccine? The answer to this isn’t known yet. This exact question is under investigation, but the chances are very likely that the vaccine also decreases transmissibility even in someone like Lynch, who tests positive as a result of exposure.

Keep in mind that in Israel, observational data has shown that in a group of over 715,425 people one week after receiving their second Pfizer shot, only 317 got COVID. Maccabi Healthcare Services in Israel also revealed that out of 163,000 given both shots, only 31 were infected, compared to 6,500 infections among a control group of unvaccinated people.

It is very clear that the shot works, as the controlled trials showed. It also appears from the Israeli data that the MRNA vaccines decrease transmission, but that hasn’t been proven yet, and Lynch is right to quarantine himself.

The purpose of immunization is to one, protect yourself, and two, protect those around you by decreasing spread.

It would appear that both the Pfizer and the Moderna vaccine are highly successful at No. 1, but it is still unproven to what extent they accomplish No. 2. Of course, Lynch having enough virus in his nose because of contact with a COVID positive associate does not in any way confirm that he is contagious, which is exactly the point. The vaccine may decrease viral load to the point where you may still test positive but no longer are as contagious. We also don’t know exactly what test the congressman had, and this could be a false-positive result.

Finally, though Pfizer measured immunity after seven days and Moderna after 14 days, this doesn’t mean that Lynch would automatically be fully immune nine days after receiving the Pfizer vaccine, as this can vary from one person to the next. The exact amount of immunity one gets with the vaccine and how long it takes to get it will be confirmed over time in millions of people as commonly available assays are developed to test neutralizing antibody titres.

In the meantime, we must err on the side of caution and isolate anyone with a positive test even if we think he or she may be immune from COVID. At the same time, a positive test like Lynch’s doesn’t automatically signal a COVID infection the way it did before. Now, in a fully vaccinated individual, it may simply mean you have some virus in your nose. This is a giant step forward in the war against COVID.

 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,499
荣誉分数
6,638
声望点数
373
14 min ago

Russia’s Sputnik V vaccine is 91.6% effective against Covid-19, interim analysis suggests​

From CNN Health’s Jessica Firger and Jamie Gumbrecht

After criticism last year for an early rollout, Russia’s Sputnik V coronavirus vaccine is 91.6% effective against symptomatic Covid-19 and 100% effective for preventing severe illness, according to an interim analysis of Phase 3 trial data published in the medical journal The Lancet on Tuesday.

The randomized, double-blind, placebo-controlled clinical trial includes data on 19,866 participants, of whom 14,964 received the vaccine and 4,902 received the placebo. There were 78 cases of Covid-19 among the trial participants, and only 16 of them had received the vaccine. The rest received a placebo, which does nothing.

The trial included 2,144 people over the age of 60, and a sub-analysis conducted on this group revealed the vaccine was well tolerated and had a similar efficacy of 91.8%.

Seventy serious adverse events were reported in 68 trial participants, including 45 in the vaccine group and 23 in the placebo group, but none were considered associated with the vaccination, according to the study. Most of the adverse events reported were mild, such as flu-like symptoms and pain at the injection site.

The analysis includes only symptomatic cases of Covid-19, and the authors note more research is needed to understand the vaccine’s efficacy against asymptomatic Covid-19, transmission and how long protection may last.

The vaccine is a two-dose adenoviral vector vaccine, with doses administered 21 days apart. With this type of vaccine, the adenovirus is altered so that it can deliver a piece of genetic material from another pathogen, such as the virus that causes Covid-19. It’s an approach similar to the vaccines developed by AstraZeneca and Johnson & Johnson.

Sputnik V uses two different vectors that are based on a human adenoviruses in separate shots. Researchers from Gamaleya National Research Centre for Epidemiology and Microbiology in Russia write that using a different adenovirus vector for the booster may create a more powerful immune response than using the same vector a second time, by minimizing the risk of immune system resistance.

Sputnik V only needs to be refrigerated and costs $10 per dose, according to the Russian Direct Investment Fund, which funded vaccine production and is responsible for selling it globally.

Some context: The vaccine is already approved in Russia, Belarus, Serbia, Argentina, Bolivia, Algeria, the Palestinian territories, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Guinea, Tunisia and Armenia. Sputnik V has so far been administered to more than 2 million people worldwide.
Russia drew criticism from scientific circles last year, when it announced the world's first approved coronavirus vaccine for public use in August -- before the crucial Phase 3 trials had been completed.

“The development of the Sputnik V vaccine has been criticised for unseemly haste, corner cutting, and an absence of transparency,” University of Reading Professor Ian Jones London School of Hygiene & Tropical Medicine Professor Polly Roy wrote in a commentary published in The Lancet Tuesday. They were not involved in the study. “But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of COVID-19.”

Read the full story here:
Russia's Sputnik V vaccine is 91.6% effective against symptomatic Covid-19, interim trial results suggest
RELATED

Russia's Sputnik V vaccine is 91.6% effective against symptomatic Covid-19, interim trial results suggest

 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,499
荣誉分数
6,638
声望点数
373

各种新冠疫苗的简介以及临床新情况和治疗更新​


Panda at USA


各种新冠疫苗简介以及临床新情况和治疗更新 介绍了辉瑞疫苗,莫德纳疫苗,强生疫苗, 牛津疫苗,Navavax 疫苗, 以及简单介绍了科兴与国药疫苗。 临床新情况介绍 治疗最新更新
 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,499
荣誉分数
6,638
声望点数
373

大规模疫苗接种pfizer vs Sinopharm​


来源: xintian 于 2021-02-02 19:32:48

这个是蛮好的超大人群全民的试验。两个国家正好使用了不同的疫苗。

Israel: pfizer mRNA vaccine, vaccination % 55%

UAE sinopharm vaccine, vaccination % 33%


是目前第一名和第二名接种率都很高55% VS 33%。 很快就就会到达》70%全民接种率。那么国家的感染人数,感染率变化,住院率,死亡率的数据是非常有力的疫苗安全性和有效性的数据。不足是两个国家感染检测的力度,覆盖率,准确性,临床数据,新冠死亡人数的标准肯定是不可能一样的。这样就不是真正的比较。

但是有数据总比没有数据更好。

Vaccine tracker
https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/
vaccine contract tracker
Covid-19 Deals Tracker: More Than (8.57 Billion Doses Reserved Worldwide
UAE covid live update
United Arab Emirates Coronavirus: 313,626 Cases and 878 Deaths - Worldometer
Isael covid live update
Israel Coronavirus: 664,651 Cases and 4,890 Deaths - Worldometer

 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,499
荣誉分数
6,638
声望点数
373

中国加入WHO新冠疫苗计划将提供1000万剂疫苗 主要用于发展中国家急需(更新版)​

2021年2月3日3:11 凌晨更新于2 天前

(新增更多细节)1 分钟阅读

路透北京2月3日 - 中国外交部新闻发言人汪文斌周三宣布,中国已正式加入世卫组织的“新冠肺炎疫苗实施计划”(COVAX),应世卫组织方面请求,中方决定向实施计划提供1,000万剂疫苗,主要用于发展中国家急需;三家中国公司已申请加入该计划。

他在外交部新闻例会上并称,世卫组织开始审批中国疫苗紧急使用的授权。中国同世卫组织等发起方保持密切沟通,为把疫苗作为全球公共产品,实现发展中国家的可及性和可负担性而共同努力。

由世界卫生组织(WHO)和GAVI疫苗联盟支持的COVAX计划将于本月开始向中低收入国家推出疫苗,预计今年将提供30亿剂中的20亿剂疫苗。

中国外交部在1月曾表示,中国疫苗研发企业科兴生物SVA.O、国药集团和康希诺生物6185.HK688185.SS已申请加入世卫组织的新冠疫苗计划。汪文斌今日宣布了供应计划,但没有透露细节。

他在周一的发布会上曾指出,中方支持国内企业同国外的合作伙伴开展疫苗联合研发和合作生产,已经向多国临床试验国家出口了国药集团和科兴公司的疫苗。中国支持有关企业向急需获取疫苗、认可中国疫苗、已授权在本国紧急使用中国疫苗的国家出口疫苗。

周二公布的一项少量采样实验室研究显示,包括中国国药在内的两种中企新冠疫苗能够激发免疫力防御南非变种病毒,但保护效果似乎较弱。(完)
发稿 沈燕;审校 屈桂娟/张喜良

 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,499
荣誉分数
6,638
声望点数
373

独家:巴西拟增购两千万剂中国科兴新冠疫苗--圣保罗州长​

2021年2月5日1:14 凌晨更新于10 小时前

路透新闻部 1 分钟阅读

路透圣保罗2月5日 - 圣保罗州长周四在接受路透采访时表示,巴西正在洽谈,准备额外购买中国科兴控股生物开发的2,000万剂新冠病毒疫苗。此举显示了其对于中国疫苗的信心。

1612541394675.png


2021年1月28日,巴西库里蒂巴,一名医务人员展示中国科兴的新冠疫苗。REUTERS/Rodolfo Buhrer

此前未有关于这笔订单的报导。州长Joao Doria表示,这将是此前订购的1亿剂科兴CoronaVac疫苗之外的新订单。圣保罗的布坦坦研究所(Butantan Institute)已经获得CoronaVac疫苗。

该国营机构在巴西领导了对该疫苗的大规模临床测试,目前正在为一项全国免疫计划分装疫苗,计划在2022年初实现100%在国内生产。另一种获准在巴西紧急使用的新冠疫苗是阿斯利康疫苗。

圣保罗是巴西最富有和人口最多的州,州长Joao Doria一直是CoronaVac疫苗在巴西进行测试和接种的幕后推手。此举有助于增强其竞选总统的信心,也加剧了他与巴西总统博尔索纳罗(Jair Bolsonaro)之间的矛盾。

但该款疫苗在巴西的实验中有效性仅略高于50%,远低于市场上其他的备选疫苗,部分人士因此质疑巴西是否应该采购其他疫苗;目前巴西是美国以外疫情最为严重的地方。

巴西卫生部与疫苗开发商洽谈采购合约时动作迟缓,对中国采批判态度、对新冠病毒存疑的博尔索纳罗虽然起初驳回科兴疫苗,但在缺乏替代品的情形下已经改变态度。

圣保罗州长表示,他预期布坦坦研究所将以每周或每10天的频率收到从中国寄送的疫苗活性成分,以克服初期可能拖慢生产的瓶颈。

布坦坦研究所一座兴建中工厂预定将自2022年1月起生产疫苗活性成分,进度落后于先前的目标今年下半年。布坦坦研究所正在协商取得额外供应2,000万剂疫苗,期能在新厂开始运作前维持最终目标不变。

目前为止,巴西卫生部只有和布坦坦研究所签订一份合约采购4,600万剂科兴疫苗供全国分配,但圣保罗州长称,他相信很快将再洽购5,400万剂。

“在攸关生死的情况下,我们不会坐等事态发展,”他说道。(完)

编译 张涛/张明钧;审校 李婷仪/刘秀红

 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,499
荣誉分数
6,638
声望点数
373

辉瑞,莫多拿,阿斯瑞卡三大公司的疫苗比较(抗体滴度, 常规保护率,对突变体效果)​


来源: 杨别青 于 2021-02-05 19:30:43
辉瑞,莫多拿,阿斯瑞卡三大公司的疫苗目前已经获得紧急使用授权,美国CDC不主张未经试验的疫苗混用,即使辉瑞和莫多拿mRNA疫苗也有明显差别:
1. 临床试验使用不同的年龄组

辉瑞:16-65岁

莫多拿:18-65岁

阿斯瑞卡: 18-65岁

2. 剂量,成分,间隔不同
  • 辉瑞(mRNA30 微克, 0.3 毫升): 两剂间隔21 天
  • 莫多拿(mRNA100 微克, 0.5 毫升): 两剂间隔28 天
  • 阿斯瑞卡:两剂间隔28 天, 病毒颗粒,5x1010
3. 抗体产生的滴度不同(生物学测试)

辉瑞:引发体液以及细胞免疫,是新冠愈后病人抗体的20倍。

阿斯瑞卡(AstraZeneca):体液以及细胞免疫,是新冠愈后病人抗体的1.8- to 2.7倍。

4. 保护率(医学效果测试)

辉瑞:95%

莫多拿:94.5%

阿斯瑞卡: 半剂量90%(2,741人参试),全剂量(5x1010)60%(8,895人参试)

4. 对最新病毒突变体的保护效果(英国,南非,巴西三个主要病毒突变体)

“英国科学家初步研究发现,肆虐当地的“B.1.1.7”新冠变种病毒株变异幅度更为剧烈,令病毒传播能力较以往强70%。”未观察到致死率的差别。
南非,巴西突变体尚未有明确的结果。

辉瑞:预印论文称对英国突变体(B.1.1.7),体外抗体中和率下降2 倍,对南非突变体(B.1.351),下降6.5倍。
辉瑞公司自称,对英国突变体保护率依然达到89.3%。

莫多拿公司自称, 对英国突变体保护率没有明显下降,但对南非突变体(B.1.351),体外抗体中和率下降6倍。
阿斯瑞卡: 尚未有数据公布

我个人看法: 从接种后产生的抗体滴度来看,mRNA疫苗产生的抗体是阿斯瑞卡疫苗抗体的10倍,保护率mRNA疫苗高于阿斯瑞卡疫苗,因而认为mRNA疫苗优于阿斯瑞卡疫苗。

2月4日,英国科学家开始为期13个月的试验以检测混用阿斯瑞卡(病毒载体疫苗)和辉瑞疫苗(mRNA 疫苗 )的效果。
2-5-2021


 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,499
荣誉分数
6,638
声望点数
373
19 min ago

Peru becomes the first Latin American country to roll out the Chinese vaccine, Sinopharm​

From CNN’s Claudia Rebaza and Mitchell McCluskey

Peru began distributing China’s Sinopharm vaccine on Tuesday morning, with frontline health care workers taking priority during the first phase of the rollout.

The country has taken part in the Sinopharm vaccine’s clinical trials since last year and becomes the first Latin American country to roll out the Chinese vaccine.

A group of doctors at Lima’s Arzobispo Loayza Hospital were the first to receive the vaccine on Tuesday morning, state news agency Andina reported.

President Francisco Sagasti is expected to be vaccinated later on Tuesday.

On Sunday, Peru received its first shipment of 300,000 doses of China's Sinopharm coronavirus vaccine, and expects to receive the remaining 700,000 doses on February 14. The armed forces will be in charge of the vaccine’s distribution across the country.

On Monday, Foreign Affairs Minister, Elizabeth Astete, announced her government has reached an agreement with Pfizer for the supply of 20 million doses of their vaccine, state news agency Andina reported.

Astete told a Congress Committee that 250,000 doses will arrive in March and at least 300,000 in April, Andina reported.

"We were assured that Peru will have received a minimum of 5,750,000 vaccines by July 1, and the supply will increase significantly to 20 million since then," Astete said.

Astete also told lawmakers her government has signed an agreement to receive 6.6 million doses from Pfizer and AstraZeneca via the Covaxprogramme to vaccinate 20% of the population.

President Sagasti, who took office in November, has faced criticism for the delay in reaching a supply agreements for the vaccine.

Peru currently has 1,186,698 confirmed cases of coronavirus and has recorded 42,308 deaths, according to data from Johns Hopkins University (JHU).

The country has been reporting more than 6,000 cases a day, an increase over the 2,000 cases a day in early January, while it is also facing a shortage of intensive care unit (ICU) beds and oxygen during this new wave of the pandemic.

Peru has the fifth highest Covid-19 case count in Latin America, after Brazil, Colombia, Argentina and Mexico according to JHU data.
 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,499
荣誉分数
6,638
声望点数
373

是时候信任中国和俄罗斯的疫苗了​

ACHAL PRABHALA, CHEE YOKE LING2021年2月9日
去年12月初,医护人员在莫斯科一家诊所为一名医生接种俄罗斯的Sputnik V新冠疫苗。业界领先的医学杂志《柳叶刀》发表的试验结果显示,Sputnik V疫苗的有效率为91.6%。
去年12月初,医护人员在莫斯科一家诊所为一名医生接种俄罗斯的Sputnik V新冠疫苗。业界领先的医学杂志《柳叶刀》发表的试验结果显示,Sputnik V疫苗的有效率为91.6%。 SERGEY PONOMAREV FOR THE NEW YORK TIMES

世上最富裕的几个国家正在竭力应对Covid-19疫苗短缺的问题,与此同时,一些穷国则担心自己根本得不到疫苗。不过这两个问题的对策可能就在眼前:来自中国和俄罗斯的疫苗,也许很快还有印度。

中国和俄罗斯疫苗一开始受到了西方和其他国际媒体的排斥,因为他们觉得,这些疫苗跟莫德纳(Moderna)、辉瑞(Pfizer)-BioNtech或阿斯利康(AstraZeneca)的出品无法相提并论。这种印象似乎在一定程度上是因为中国和俄罗斯是专制国家

但是我们早就已经看到这些疫苗在这些国家取得良好效果的证据。顶尖医学期刊《柳叶刀》(The Lancet)上周发表的末期试验中期结果显示,俄罗斯的疫苗Sputnik V有效率达到91.6%。这验证了疫苗开发者加马列亚中心(Gamaleya Center)和俄罗斯直接投资基金(Russian Direct Investment Fund)在去年12月中旬公布的发现

阿联酋、巴林、埃及、约旦、伊拉克、塞尔维亚、摩洛哥、匈牙利和巴基斯坦已经批准了中国国药(Sinopharm)的疫苗;截至今年1月中旬,阿联酋已经有180万人接种了这种疫苗。玻利维亚、印度尼西亚、土耳其、巴西和智利已经批准并开始接种科兴(Sinovac)的另一种中国疫苗。Sputnik V将在欧洲、中东、非洲和拉美的十几个国家进行接种。

在审核这些疫苗时,这些国家做了周祥的考虑,他们以中国和俄罗斯生产厂家提供的安全和效力证据为基础,而那些证据有相当一部分也发表在了《柳叶刀》和《美国医学会杂志》(JAMA)等同行评审的科学期刊上——有的还进行了自己的独立试验。质疑这些决策,就是在质疑这些政府的能力或诚信,其中一些国家的卫生监管系统并不比美国或欧洲差。

面对严重的疫苗短缺和递送延误,法国西班牙德国也已经在考虑订购中国和俄罗斯的疫苗。看起来,情急之下,他们终于开始表示不要对非西方疫苗有“成见”了。

但疑心并没有散去。俄罗斯疫苗在伊朗、中国疫苗在巴基斯坦,以及两者在肯尼亚南非,都遭到了质疑。YouGov近日对17个国家的19000人展开调查,向其询问对各国开发疫苗的“正面或负面”看法:俄罗斯、中国和印度排在末尾(只有伊朗除外)。

这在一定程度上是可以理解的。中国和俄罗斯出于自身的考虑进行宣传,大肆夸耀他们各自的疫苗,这只会让人愈发警惕,尤其是在国外。

中国和俄罗斯去年还在没有末期(或称三期)临床试验效力数据的情况下给部分国民接种。(辉瑞-BioNTech和莫德纳的疫苗是在得出三期试验中期分析结果后得到美国批准的。)印度近日也在用巴拉特生物科技(Bharat Biotech)开发的疫苗Covaxin做同样的事,引起了举国的愤怒。

这三个国家的政府都辩称,此举是加快疫苗生产和分配所须的紧急措施。这种解释对有些人来说可能是不够的,但这样做并不违法,西方的监管机构也会出于同样的原因走捷径(尽管会更透明一些)。

而现在已有重要数据能证明中俄疫苗的有效性。(要判断Covaxin疫苗有效性还为时过早。)去年12月初在阿联酋进行的试验结果显示,国药疫苗的有效性为86%;它在中国的试验有效性为79%。

需要说明的是,这些有效性数据衡量的标准究竟是什么,意义又是什么。对此的困惑引发了人们对疫苗的怀疑——尽管对某些疫苗的怀疑要多于其他疫苗。
以科兴疫苗为例,关于它的效果,似乎存在互相矛盾的结果:土耳其试验的有效性为91%,印度尼西亚为65%,巴西为50.4%。巴西的结果迅速登上国际新闻头条,尽管进行这些试验的国家研究中心——位于圣保罗的布坦坦研究所(Butantan Institute)的研究人员也指出,该疫苗在预防新冠轻症到重症方面的有效率为78%。

1月底,我们采访了布坦坦研究所的临床研究医学总监里卡多·帕拉西奥斯(Ricardo Palacios),他告诉我们,这些试验被有意设计成了“压力测试”。他说,这些试验仅在“直接看护新冠病人的医务工作者”中进行。(辉瑞-BioNTech莫德纳疫苗的试验对象包括一些医务工作者和其他高危人群,但并不仅限于他们。)而且,当研究对象是更容易受到感染的人群时,疫苗的效果可能就不是那么好了。布坦坦研究所的试验对于新冠症状的定义也比其他试验更广泛。

换句话说,即使是对同一种疫苗,试验方案也不尽相同。考虑到这一点,现在再想象一下不同疫苗试验结果之间可能存在的差异——它反映的可能不仅仅是疫苗的效果,还可能说明试验的设计。

一名中国医务工作者在北京接种新冠疫苗。对于“有效性”到底衡量什么、意味什么的困惑引发了人们对疫苗——以及一些疫苗是否比其他疫苗更有效的怀疑。

一名中国医务工作者在北京接种新冠疫苗。对于“有效性”到底衡量什么、意味什么的困惑引发了人们对疫苗——以及一些疫苗是否比其他疫苗更有效的怀疑。 KEVIN FRAYER/GETTY IMAGES

毫无疑问,必须向公众公布更多关于中俄疫苗的信息,但西方领先的疫苗在某种程度上也应如此。并非所有辉瑞-BioNTech和莫德纳疫苗试验的细节或原始数据都被公开,甚至连研究人员都看不到。

事实是,新冠疫苗的研发或公布都没有达到应有的透明度。虽然中俄疫苗的推出可能比一些西方企业糟糕,但这并不一定意味着其疫苗是劣质的。

越来越多的证据表明,中俄的疫苗是可靠的,应得到严肃对待,而且特别考虑到全世界都出现的供应问题,还得尽快严肃对待。

大多数西方制造的疫苗已经被发达国家买光:根据呼吁在世界范围内更广泛和公平地获取疫苗的组织联盟“人民疫苗联盟”(People’s Vaccine Alliance)的数据显示,截至12月初,莫德纳的所有疫苗和96%的辉瑞-BioNTech疫苗都已卖完。

全球疫苗免疫联盟(Gavi)储存了部分西方疫苗。但根据我们对其供应数据的统计,截至本周,预计在今年第一季度,它只能发运1.1亿至1.22亿剂阿斯利康疫苗,辉瑞-BioNTech疫苗则只有120万剂——而这些疫苗要供应所有与全球疫苗免疫联盟签订了新冠疫苗协议的145个国家。

而且,西方多数大型药企都拒绝向非西方制造商授权其疫苗,一些发达国家正在阻止印度和南非的一项提议,即要世界贸易组织(World Trade Organization)暂时撤销对新冠相关疫苗和治疗方法的部分知识产权保护。

另一方面,根据分析公司Airfinity提供的最新数据分析,科兴已经签订了协议,今年将向12国出口3.5亿剂疫苗;国药疫苗则准备向11国出口1.94亿剂;
Sputnik V疫苗向17国出口约4亿剂。三家制造商都公开表示,它们在2021年都有生产多达10亿剂疫苗的能力。三家公司也都已将疫苗授权给多个国家的本地制造商。

那么,如何才能使这些疫苗对更多需要它们的人具有吸引力呢?一种办法是让有专业技术知识的国际组织对它们进行正式评估。目前的问题是,世界卫生组织(World Health Organization)的疫苗认证规则本身就是偏向富裕的、基本都在西方的国家。

世卫组织有一份清单,上面列出了它在质量管控上信任的“严格监管机构”——除了澳大利亚、加拿大、日本和美国,其余都是欧洲国家。在世界其他地区,世卫组织采用一种被称为预认证的手续。在理论上,通过这种办法,中国或俄罗斯的疫苗可以获得与西方疫苗同等的权重。但在现实中,这是一个繁复且耗时的程序。

当在世卫组织信任名单上的国家研发并批准了一种疫苗,该组织通常会基于该评估将其迅速批准。但当其他国家的疫苗制造商申请预认证的时候,世卫组织要从头开始进行全面评估,包括对生产设施的实际检查。

在制造商提出申请不到两个月后,世卫组织于2020年底批准了辉瑞-BioNTech疫苗,并预计将在本月对莫德纳和阿斯利康疫苗做出决定。中俄疫苗仍在排队等待,尽管对它们的审查程序开始得更早。

在审查辉瑞-BioNTech疫苗的过程中,世卫组织与欧洲药品管理局(European Medicines Agency,简称EMA)进行了密切合作,在EMA批准疫苗的10天后也完成了批准。在维持标准的同时,世卫组织没有理由不能与其他国家的卫生监管机构合作,帮助当地疫苗制造商通过审批程序。它必须立即给予所有疫苗生产国应有的重视。

一些医生和活动人士已经提议,要在世界范围内增加西方生产的疫苗的供应。这些呼吁是善意的,但同样也认定只有西方国家的疫苗才值得拥有——以及等待。

眼下已经有了一个更简单的解决办法:是时候信任其他国家的疫苗了。


更正:由于翻译错误,本文中文版稍早时称国药疫苗似乎存在矛盾的结果,应为科兴疫苗。特此更正。

Achal Prabhala是AccessIBSA项目协调员,该项目为获得医药品进行活动,他也是Shuttleworth基金的一名研究员。Chee Yoke Ling是Third World Network执行理事,这个国际政策研究、权利促进组织总部位于马来西亚槟城。

翻译:纽约时报中文网

点击查看本文英文版。

 

向问天

日月神教光明左使
VIP
注册
2012-09-04
消息
60,240
荣誉分数
10,956
声望点数
1,273
需要说明的是,这些有效性数据衡量的标准究竟是什么,意义又是什么。以科兴疫苗为例,关于它的效果,似乎存在互相矛盾的结果土耳其试验的有效性为91%,印度尼西亚为65%,巴西为50.4%。巴西的结果迅速登上国际新闻头条,尽管进行这些试验的国家研究中心——位于圣保罗的布坦坦研究所(Butantan Institute)的研究人员也指出,该疫苗在



西方的报道真没有啥公正性。
 

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,499
荣誉分数
6,638
声望点数
373
3 hr 47 min ago

Mexico grants emergency use approval for 2 China-made Covid-19 vaccines​

From CNN's Eric Cheung

A health worker shows the Sinovac vaccine at a community health centre in Lambaro, Indonesia on January 18.
A health worker shows the Sinovac vaccine at a community health centre in Lambaro, Indonesia on January 18. Chaideer Mahyuddin/AFP/Getty Images

Mexico has issued emergency use approval for China's CanSino and Sinovac coronavirus vaccines, the country's deputy health minister Hugo Lopez-Gatell announced Wednesday.

He said the approval was granted by Mexico's Federal Committee for Protection from Sanitary Risks (Cofepris) after it reviewed the vaccines' quality, safety and efficacy, according to a statement posted on the Health Ministry's website.

The first bulk shipment of the CanSino vaccine will arrive in Mexico from China on Thursday, where it will be packed at a plant in the central city of Queretaro, the statement said.

Mexico has also issued an emergency use authorization for Russia's Sputnik V coronavirus vaccine and ordered millions of doses.

At least 1,957,889 confirmed Covid-19 cases and 169,760 deaths have been reported in Mexico, according to Johns Hopkins University.
 
最后编辑:

lindamy

时代广场舞照跳
VIP
注册
2005-11-23
消息
26,499
荣誉分数
6,638
声望点数
373
5 min ago

Chile inoculates more than 1 million people, a week into its mass vaccination program​

From CNN's Eric Cheung
Seniors wait to be vaccinated with China's Sinovac Covid-19 vaccine at a vaccination center in Santiago, Chile, on February 3.
Seniors wait to be vaccinated with China's Sinovac Covid-19 vaccine at a vaccination center in Santiago, Chile, on February 3. Esteban Felix/AP

More than one million people have been inoculated in Chile since the country began its mass coronavirus vaccination program one week ago, Chilean President Sebastian Pinera tweeted Wednesday.

“Let’s make 2021 the year of hope,” the tweet said. “Together we will overcome this pandemic and regain the joy of living.”

Chile kicked off its mass vaccination campaign last Wednesday, and the government set a target to vaccinate 15 million by mid-year. The first doses of the vaccine arrived in the country in December and were given to medical workers from December 24.

In January, Chile issued an emergency-use authorization for China's Sinovac Covid-19 vaccine. The country has also been using the Pfizer/BioNTech vaccine for health officials and the elderly.

Chile's total population is close to 19 million, according to the World Bank. The country has reported at least 760,576 Covid-19 cases and 19,105 deaths, according to Johns Hopkins University.
 
顶部