Novavax to submit COVID-19 vaccine to FDA for approval
UPDATED 9:04 AM PT – Monday, June 14, 2021
Novavax plans to apply for FDA authorization of its two shot COVID-19 vaccine in the U.S. during the third quarter of this year. The biotech company released late-stage study results Monday, showing it’s vaccine had 90 percent efficacy even with many variants of the coronavirus.
The announcement comes as federal officials say the U.S. has more than enough doses of COVID-19 vaccines to finish vaccinating the entire American population. However, Novavax said the vaccine can be used for those who may need boosters after six to 12 months as well as be donated to countries in need.
“We need vaccines to go globally, particularly in low and middle income countries,” stated Novavax CEO Stanley Erck. “And our vaccine is uniquely suited for that because it is stable with normal refrigerator temperatures and that will help.”
NEW DATA RELEASE: Novavax #COVID19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial https://t.co/lIOiQXxDtD pic.twitter.com/4ePHxDpziZ
— Novavax (@Novavax) June 14, 2021
Novavax confirmed it remains on track to manufacture 150 million doses per month by the end of the year.