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]

1 hr 33 min ago
Johnson & Johnson is taking steps to resume its US Covid-19 vaccine trial
From CNN's Jamie Gumbrecht

This September 2020 photo provided by Johnson & Johnson shows vials for a single-dose Covid-19 vaccine being developed by the company. Cheryl Gerber/Johnson & Johnson via AP

Johnson & Johnson said Friday the independent monitoring board overseeing its phase 3 Covid-19 vaccine trial in the United States has recommended resuming the trial, which was paused earlier this month after a participant became ill.

Preparations to resume the trial in the US are now underway, the company said, including submissions for approval by Institutional Review Boards. Johnson & Johnson’s statement did not specify when the trial would begin again.

Some context: The trial was put on hold Oct. 12 due to a study participant's "unexplained illness," the company said. Johnson & Johnson said Friday “no clear cause” was identified for a trial participant’s “serious medical event.”

“There are many possible factors that could have caused the event. Based on the information gathered to date and the input of independent experts, the company has found no evidence that the vaccine candidate caused the event,” the company’s statement said.

The Johnson & Johnson vaccine trial started Sept. 23 with a plan to recruit 60,000 patients in eight countries, including the United States. In its statement Friday, Johnson & Johnson’s said discussions with regulators around the world are “progressing.”

The trial’s full safety and efficacy results will be shared when the trial concludes, the company said.

During an Operation Warp Speed briefing on Friday, US Health and Human Services Deputy Chief of Staff for Policy Paul Mango said they were “very optimistic” the Johnson & Johnson trial would resume “as quickly as possible.”

 

[lindamy]

3 hr 32 min ago
AstraZeneca will resume its Covid-19 vaccine trial in the US
From CNN's Maggie Fox

Drugmaker AstraZeneca will resume the trial of its experimental coronavirus vaccine in the United States, which has been on hold since September.

The company said the US Food and Drug Administration authorized the restart Thursday after reviewing all of the global safety data and concluding it was safe to resume. The trial had already resumed in other countries.

The trial was paused after a volunteer in Britain developed a neurological condition suffered by one of the participants in its coronavirus vaccine clinical trials around the world.

Government health officials, as well as outside experts, have said the hold is an example of how the safety process is working and protecting Americans from any potentially dangerous vaccines. Regulators wanted to check to make sure any problems could not have been caused by the vaccine.

The company has been working with Britain’s University of Oxford to develop the vaccine, one of four that started late-stage, Phase 3 trials in the US.

An internal AstraZeneca safety report obtained by CNN last month showed the study volunteer, a previously healthy 37-year-old woman, “experienced confirmed transverse myelitis” after receiving her second dose of the vaccine, and was hospitalized on Sept. 5. The woman was enrolled in the UK arm of the trial, which is run by the University of Oxford.

The document, labeled an “initial report,” described how the study participant had trouble walking, weakness and pain in her arms, and other symptoms.
The company said in the release Thursday that results from late-stage trials are expected later this year, depending on infection rates where the trials are being conducted.

 

[向问天]

美国今天7万多人确诊。
美国是个大毒窝啊。

 

[lindamy]

美国今天7万多人确诊。
美国是个大毒窝啊。

过8万了

 

[向问天]

过8万了

是现在的气温对病毒的传播最合适吧？

 

[lindamy]

是现在的气温对病毒的传播最合适吧？

这几天每天创新高，昨天47万9，今天已经48万9了。夏天是美国，印度，巴西，现在是十多个国家过万。也包括南半球的阿根廷。

 

[向问天]

这几天每天创新高，昨天47万9，今天已经48万9了。夏天是美国，印度，巴西，现在是十多个国家过万。也包括南半球的阿根廷。
浏览附件934898

这个病毒厉害呀！
全世界只有中共能对付啊

 

[peterchen]

韩国疫苗，出事了。

疫情之下，邻邦韩国压力巨大，为防今冬可能出现的流感和新冠双重感染，日前韩国政府决定为18岁以下和65岁以上人群免费接种流感疫苗。

不想，却引发了一系列悲剧。

截至10月23日下午1点，已有36人在接种后死亡。

而这次疫苗，计划接种1900万韩国民众，

已接种1297万人

 

[lindamy]

When it comes to COVID-19 vaccines, how good will be good enough?

Despite the cheering on of the groups in the vaccine race, it’s not a sure thing that the vaccines reaching phase III trials are going to deliver us back to normal

Author of the article:
Sharon Kirkey
Publishing date: Oct 28, 2020 • Last Updated 10 hours ago

When it comes to COVID-19 vaccines, how good will be good enough?

Despite the cheering on of the groups in the vaccine race, it’s not a sure thing that the vaccines reaching phase III trials are going to deliver us back to normal

ottawacitizen.com

 

[Ottawa005]

2020年10月30日08:55 CST

知情人士透露，根据德国政府和一家正在试验新冠疫苗的德国公司推出的计划，德国可能成为首批开始为民众接种新冠疫苗的西方国家。

根据该计划，目前存放在德国中央仓库的疫苗将在获得批准后数小时内运往60多个地区疫苗接种中心。

这项计划可能会在今年年底前实现，具体取决于目前处于后期阶段的临床试验，以及欧洲药品管理局(European Medicines Agency)的批准。欧洲药品管理局是美国食品药品管理局(FDA)的欧盟对等机构。

根据德国联邦州政府起草的名单，新冠疫苗最初的接种对象包括医疗工作者、老年人、临床弱势人群、执法官员和生活在拥挤环境的民众，一般民众则将在几个月后接受接种。

德国计划在今年启动新冠疫苗接种

知情人士透露，根据德国政府和一家正在试验新冠疫苗的德国公司推出的计划，德国可能成为首批开始为民众接种新冠疫苗的西方国家。

cn.wsj.com

 

[向问天]

2020年10月30日08:55 CST

知情人士透露，根据德国政府和一家正在试验新冠疫苗的德国公司推出的计划，德国可能成为首批开始为民众接种新冠疫苗的西方国家。

根据该计划，目前存放在德国中央仓库的疫苗将在获得批准后数小时内运往60多个地区疫苗接种中心。

这项计划可能会在今年年底前实现，具体取决于目前处于后期阶段的临床试验，以及欧洲药品管理局(European Medicines Agency)的批准。欧洲药品管理局是美国食品药品管理局(FDA)的欧盟对等机构。

根据德国联邦州政府起草的名单，新冠疫苗最初的接种对象包括医疗工作者、老年人、临床弱势人群、执法官员和生活在拥挤环境的民众，一般民众则将在几个月后接受接种。

德国计划在今年启动新冠疫苗接种

知情人士透露，根据德国政府和一家正在试验新冠疫苗的德国公司推出的计划，德国可能成为首批开始为民众接种新冠疫苗的西方国家。

cn.wsj.com

第三期试验完成了吗？

 

[lindamy]

2 hr 26 min ago

Moderna expects to know by the end of the month whether Covid-19 vaccine works​

From CNN Health's Elizabeth Cohen

A blood sample is prepared for analysis by a laboratory technician at Accel Research Sites on August 4, in DeLand, Florida, during the Phase 3 COVID-19 vaccine clinical trial sponsored by Moderna. Paul Hennessy/NurPhoto/Getty Images/FILE

Moderna has finished accumulating data for a first analysis of its Covid-19 vaccine and expects to have an announcement on the vaccine’s efficacy by the end of the month, according to a company statement.

Pfizer announced Monday that its coronavirus vaccine is more than 90% effective.

How it works: Moderna is conducting a clinical trial of 30,000 participants, with half receiving the vaccine and half receiving a placebo, which is a shot of saline that does nothing.

What they need: For Moderna’s vaccine to be considered for authorization by the US Food and Drug Administration, at least 53 study participants need to become ill with Covid-19. The trial hit that 53 mark Wednesday, but Moderna doesn’t know if the participants who became ill received the vaccine or the placebo.

What happens now: The company is preparing data to send to the trial’s Data and Safety Monitoring Board, an independent panel of experts. That board will look to see how many of the participants who became ill received the vaccine and how many received the placebo. If a statistically significant number received the placebo, that means the vaccine is effective against the virus.

Moderna thinks the board will report their efficacy results before the end of the month. Moderna expects that by the time the announcement is made, more than 53 participants will become ill with Covid-19, since cases are rapidly rising in the US.

Pfizer's interim analysis looked at the first 94 confirmed cases of Covid-19 among more than 43,000 volunteers who got either two doses of the vaccine or a placebo. Russia's Sputnik V vaccine interim analysis came after just 20 confirmed Covid-19 cases.

Dr. Anthony Fauci said Wednesday that Moderna’s vaccine could soon follow in Pfizer's footsteps.

“Moderna has an almost identical mRNA,” Fauci told Financial Times correspondent Hannah Kuchler. “We hope we're going to see a similar kind of result from Moderna. If we do, then we'll have two vaccines in play.”

He said he would "really be surprised if we did not see a high degree of efficacy."

 

[lindamy]

1 hr 17 min ago

Medicago and GlaxoSmithKline announce Covid-19 vaccine trials​

From CNN's Jacqueline Howard

The GlaxoSmithKline company headquarters in London, England. Martyn Williams/Alamy

Biopharmaceutical company Medicago has developed an experimental coronavirus vaccine candidate, which uses drug giant GlaxoSmithKline's (GSK) adjuvant.

An adjuvant is added to some vaccines to enhance the immune response, which creates stronger immunity against infections.

In this case, Medicago's vaccine uses virus-like particles grown in a close relative of the tobacco plant. The vaccine combines the particles with GSK's adjuvant to generate an immune response.

The two companies announced on Thursday that the vaccine candidate was entering Phase 2 and 3 clinical trials.

The trial will evaluate the vaccine's efficacy, safety and ability to provoke an immune response.

"Our Phase 1 results of the adjuvanted vaccine candidate were very encouraging and fully support further clinical evaluation," Nathalie Landry, executive vice president of scientific and medical affairs at Medicago, said Thursday.
"This is the first of several GSK Covid-19 vaccine candidate collaborations to start Phase 2/3 clinical testing and an important step forward in our contribution to the global fight against the pandemic," Thomas Breuer, chief medical officer of GSK Vaccines, said.

The Phase 2 trial will part be conducted in multiple sites in Canada and, upon allowance from the US Food and Drug Administration, in the US.

The volunteers will include healthy adults ages 18 to 64 and elderly adults over 65, according to the announcement. Each age group will include more than 300 subjects.

 

[lindamy]

4 hr 44 min ago

South Korean company to produce 150m annual doses of Russian Covid-19 vaccine​

From CNN's Zahra Ullah in Moscow

A heath worker draws the vaccine known as 'Sputnik V' from a vial during a trial at a clinic in Moscow, Russia, on September 23. Andrey Rudakov/Bloomberg via Getty Images

South Korean biotechnology company GL Rapha will produce over 150 million doses of Russia's Sputnik V Covid-19 vaccine per year, the Russian Direct Investment Fund (RDIF) said Friday.

The doses are set to be distributed around the world, the RDIF said.

Russia claims that Phase 3 clinical trials have shown the vaccine to be 92% effective against Covid-19, "based on 20 confirmed Covid-19 cases split between vaccinated individuals and those who received the placebo."

The Phase 3 trial is yet to be completed and will continue for six more months. Scientists have reacted to the early Phase 3 data with caution, especially as Russia's claims are based on just 20 cases.

Moscow drew criticism from scientific circles when it announced the world's first approved coronavirus vaccine for public use in August -- even before the crucial Phase 3 trials had been completed.

 

[lindamy]

12 min ago

Moderna's vaccine has a significant advantage over Pfizer's​

From CNN's Elizabeth Cohen

Moderna announced this morning that its coronavirus vaccine is 94.5% effective against the virus, making it the second vaccine in the United States to have a stunningly high success rate.

Last week, Pfizer announced that early data show its vaccine is more than 90% effective against the disease.

While the two vaccines appear to have very similar safety and efficacy profiles, Moderna's vaccine has a significant practical advantage over Pfizer's.

Pfizer's vaccine has to be kept at minus 75 degrees Celsius — or about minus 103 degrees Fahrenheit. No other vaccine in the US needs to be kept that cold, and doctors' offices and pharmacies do not have freezers that go that low.

Moderna's vaccine can be kept at minus 20 degrees Celsius, which is about minus 68 agrees Fahrenheit. Other vaccines, such as the one against chickenpox, need to be kept at that temperature.

That means Moderna's vaccine can be kept in "a readily available freezer that is available in most doctors' offices and pharmacies," said Dr. Tal Zacks, Moderna's chief medical officer. "We leverage infrastructure that already exists for other marketed vaccines."

Another advantage of Moderna's vaccine is that it can be kept for 30 days in the refrigerator, the company announced Monday.

Pfizer's vaccine can last only five days in the refrigerator.