FDA guides on COVID-19 vaccine approval criteria

FDA guides on COVID-19 vaccine approval criteria
Jun. 30, 2020 12:01 PM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor 
The FDA has released guidance on its standards for approving a COVID-19 vaccine, including a requirement that it must demonstrate that it is at least 50% more effective than placebo (a low bar compared to vaccines for other infectious diseases).

The agency says it will not approve any candidate unless safety and efficacy have been clearly shown in a clinical study, an obvious criterion, nor if the vaccine simply leads to antibodies in the bloodstream (due to the uncertainty of knowing what level of antibodies confer immunity against the SARS-Cov-2 virus).

It will also require a vaccine maker to conduct further safety monitoring post approval and will recommend following all vaccinated people for a year.

The FDA has drawn criticism over its quick approvals allowing the emergency use of diagnostic tests and certain drugs during the pandemic. After a number of the tests were found to be poor performers, it tightened its review process and rescinded EUA on some assays. It OK'd the emergency use of malaria drugs chloroquine and hydroxychloroquine then backtracked after neither proved effective in treating the respiratory infection.

所有跟帖： 

• 疫苗的好消息应该快出来了 -northpeople- ♀ (0 bytes) () 06/30/2020 postreply 15:08:25

• 50%应该很多疫苗都能过吧。 -Phoenix16- ♀ (0 bytes) () 06/30/2020 postreply 15:17:09

• 50%是指疫苗candidates吗？ -northpeople- ♀ (0 bytes) () 06/30/2020 postreply 15:26:31

• 50% more effective than placebo (a low bar compared to vaccines -Phoenix16- ♀ (0 bytes) () 06/30/2020 postreply 15:31:41

• placebo无效的话，比它好50%还是无效。 -uptrend- ♂ (0 bytes) () 06/30/2020 postreply 16:34:32

• INO是不是够呛了？连基本的抗体数据都没有！ -清照卷珠帘- ♀ (0 bytes) () 06/30/2020 postreply 15:40:18

• 从Yahoo Finance看到的：The results are great, it's just not enough ti -Phoenix16- ♀ (278 bytes) () 06/30/2020 postreply 15:44:06

• 你觉得哪家最有希望？ -northpeople- ♀ (0 bytes) () 06/30/2020 postreply 16:00:17

• 你自从12块把ino卖了，就天天给ino念咒儿。自己要反省自己的水平 -xinxin76- ♀ (0 bytes) () 06/30/2020 postreply 18:24:19

• 我在Ino这也屡屡犯错。不是卖的早看它飞扬直上，就是该卖的时候没卖看它跌的跺脚。好难！ -Phoenix16- ♀ (0 bytes) () 06/30/2020 postreply 18:30:17

• 如果ino通过，将是世界上第一个DNA疫苗，是人类医学史上重大进步 -xinxin76- ♀ (0 bytes) () 06/30/2020 postreply 18:34:18

• 是啊。希望Dr Kim 和女科学家Dr Kate为人类做贡献，全世界也能转危为安。 -Phoenix16- ♀ (50 bytes) () 06/30/2020 postreply 18:37:45

• 美国在这样危急的时刻也不走寻常路，还是要追求科技创新，敢想敢拼 -xinxin76- ♀ (0 bytes) () 06/30/2020 postreply 18:46:21

• 希望川普能Open-minded, 不要因为Kim是韩裔，和韩国人合作就不多给Funding. -Phoenix16- ♀ (0 bytes) () 06/30/2020 postreply 19:09:25

• 是我吗？我只记得买卖过赚过钱，具体多少钱忘了！水瓶是不行，一直在学习！ -清照卷珠帘- ♀ (0 bytes) () 06/30/2020 postreply 20:09:47

• 50% VE 应改是一个中性的标准，需要看是不是yu，还是降低住院利， -三丝- ♂ (258 bytes) () 06/30/2020 postreply 16:28:15

• 为啥Ino最沒希望？展开说说？ -Phoenix16- ♀ (0 bytes) () 06/30/2020 postreply 16:37:15

• INO 技术是不是比较新，如果新技术FDA审批需要的数据应该比较严。 -northpeople- ♀ (0 bytes) () 06/30/2020 postreply 18:42:41

• 它是第一家DNA，没有成功先例，是第一个吃葡萄的，难度要大。但审核要求应该是一样的，看临床数据，符不符合FDA要求。 -Phoenix16- ♀ (0 bytes) () 06/30/2020 postreply 18:50:54

• 因为他手里没有 -xinxin76- ♀ (0 bytes) () 06/30/2020 postreply 18:25:33

• 你比国防部还牛呀 -xinxin76- ♀ (0 bytes) () 06/30/2020 postreply 18:27:14