每次都是压着deadline的最后一天 Novavax announced Monday that it has formally submitted a request for the US Food and Drug Administration to authorize its coronavirus vaccine for emergency use in the United States. "We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic," Stanley Erck, Novavax''''''''s president and chief executive officer, said in the announcement Monday. The vaccine can be stored at normal refrigeration temperatures, between 2 and 8 degrees Celsius (about 35 to 46 degrees Fahrenheit), and has a shelf life of about nine months, according to the company. Erck told CNN in November that if the FDA gives the green light for the EUA, the first 100 million doses of the protein-based vaccine will be ready to ship. Novavax''''''''s vaccine -- administered as two doses, three weeks apart -- is made using small, laboratory-built pieces of the coronavirus to stimulate immunity, a more traditional approach for vaccine development that some people may be more familiar or comfortable with, compared with the mRNA vaccines made by Moderna and Pfizer/BioNTech. "In the US, the primary market I think in 2022 is going to be to supply a vaccine, our normal two-dose regimen, to a lot of people who have been hesitant to get other vaccines," Erck said in November. "And to provide a booster."
同时moderna得到了full approval The Novavax filing with the FDA comes the same day the FDA gave full authorization to Moderna’s vaccine, moving it from emergency use authorization. Pfizer received full FDA authorization for its COVID vaccine in August. Moderna's Covid-19 vaccine has received full approval from the US Food and Drug Administration, according to news releases from the FDA and Moderna. The vaccine, named Spikevax, is now approved for use in people ages 18 and older. It is not approved or authorized for use in younger individuals. There's no difference between the approved vaccine and the vaccine previously available through emergency use authorization.
To date, Novavax has received conditional approval authorization from the European Union and Emergency Use Listing from the World Health Organization. It has also received authorization in India, and its two-dose vaccine is already being distributed in Indonesia and the Philippines. Last week, Israel’s Ministry of Health agreed to purchase up to 10 million doses of the COVID-19 vaccine, pending necessary authorizations.
hacker news上牛人好多 有位同学说 There's some known HIV "bnAbs", or broadly neutralizing antibodies. The thing is, these are not the antibodies most humans develop in response to HIV. Previous HIV vaccine attempts have only done a fair job at eliciting these broadly neutralizing responses. e.g. SAV001, a "whole killed" HIV vaccine, only produces broadly neutralizing antibodies in about a third of recipients (and less broadly neutralizing response in a much bigger fraction). The mRNA approach, like some recombinant approaches, seeks to generate just portions of envelope protein to tailor the response to produce these bnAbs. 这个broadly neutralizing antibody听上去很靠谱 有知道的同学能说说为啥新冠没用上吗
Novavax announced Monday that it has formally submitted a request for the US Food and Drug Administration to authorize its coronavirus vaccine for emergency use in the United States.
"We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic," Stanley Erck, Novavax''''''''s president and chief executive officer, said in the announcement Monday.
The vaccine can be stored at normal refrigeration temperatures, between 2 and 8 degrees Celsius (about 35 to 46 degrees Fahrenheit), and has a shelf life of about nine months, according to the company. Erck told CNN in November that if the FDA gives the green light for the EUA, the first 100 million doses of the protein-based vaccine will be ready to ship.
Novavax''''''''s vaccine -- administered as two doses, three weeks apart -- is made using small, laboratory-built pieces of the coronavirus to stimulate immunity, a more traditional approach for vaccine development that some people may be more familiar or comfortable with, compared with the mRNA vaccines made by Moderna and Pfizer/BioNTech.
"In the US, the primary market I think in 2022 is going to be to supply a vaccine, our normal two-dose regimen, to a lot of people who have been hesitant to get other vaccines," Erck said in November. "And to provide a booster."
The Novavax filing with the FDA comes the same day the FDA gave full authorization to Moderna’s vaccine, moving it from emergency use authorization. Pfizer received full FDA authorization for its COVID vaccine in August.
Moderna's Covid-19 vaccine has received full approval from the US Food and Drug Administration, according to news releases from the FDA and Moderna.
The vaccine, named Spikevax, is now approved for use in people ages 18 and older. It is not approved or authorized for use in younger individuals. There's no difference between the approved vaccine and the vaccine previously available through emergency use authorization.
spikevax!!
To date, Novavax has received conditional approval authorization from the European Union and Emergency Use Listing from the World Health Organization. It has also received authorization in India, and its two-dose vaccine is already being distributed in Indonesia and the Philippines.
Last week, Israel’s Ministry of Health agreed to purchase up to 10 million doses of the COVID-19 vaccine, pending necessary authorizations.
+1
印度早批了 不过打过的人数多少我不知道
不觉得FDA会在短期内批准Novavax在孩子上用。现在连大人身上的都还没批准，还要12-16, 然后5-12. 还差的远。
说的轻巧。肯定技术有瓶颈做不出来啊。 能做Fauci不早喊着做了。再骗一轮钱
有位同学说
There's some known HIV "bnAbs", or broadly neutralizing antibodies. The thing is, these are not the antibodies most humans develop in response to HIV. Previous HIV vaccine attempts have only done a fair job at eliciting these broadly neutralizing responses. e.g. SAV001, a "whole killed" HIV vaccine, only produces broadly neutralizing antibodies in about a third of recipients (and less broadly neutralizing response in a much bigger fraction). The mRNA approach, like some recombinant approaches, seeks to generate just portions of envelope protein to tailor the response to produce these bnAbs.
这个broadly neutralizing antibody听上去很靠谱 有知道的同学能说说为啥新冠没用上吗
这个是传统技术，如果mandate俺还宁愿打这个
而且这个cleavage修改掉了，也许没有元株毒呢？
嗯 有道理
哎，这个要是做出来市场也很大啊
咱中年妇女应该不会mandate这个了，小孩不知道咋样