Novavax seeks FDA emergency use authorization of its vaccine

(CNN)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.

 

The request is based on data that includes the results of two large clinical trials that demonstrated an overall efficacy of about 90% and a "reassuring safety profile," according to the company.

"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.

 

 

Novavax announced in June that its vaccine candidate was found to have an overall efficacy of 90.4% in a Phase 3 trial conducted across the United States and Mexico; the trial took place before the Omicron variant dominated in the United States.

In December, the company said it had finished its final submission package to the FDA for emergency use authorization of the vaccine, called NVX-CoV2373.

 

he 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.

...

https://www.cnn.com/2022/01/31/health/novavax-fda-eua-request/index.html

所有跟帖： 

• Novavax 终于递出了正式申请，啊哈哈哈... -va168- ♀ (0 bytes) () 01/31/2022 postreply 11:52:35

• 真出货了才有戏唱,哪怕印度那边解决了大生产问题也好. -5181- ♂ (0 bytes) () 01/31/2022 postreply 12:30:12

• FDA 有检查生产环节 -va168- ♀ (0 bytes) () 01/31/2022 postreply 15:06:02

• 还eUA 呐 -julie116- ♀ (0 bytes) () 01/31/2022 postreply 12:04:48

• 第三针有着落了.... -va168- ♀ (0 bytes) () 01/31/2022 postreply 15:05:16