FDA Authorizes Novavax COVID Vaccine for Adults
PUBLISHED WED, JUL 13 20224:24 PM EDT UPDATED WED, JUL 13 20224:48 PM EDT
KEY POINTS
- FDA authorization of Novavax’s vaccine was delayed for weeks as the agency reviewed changes to the company’s manufacturing process.
- The Novavax shot is based on more conventional protein technology used for decades in hepatitis B and HPV vaccines, while Pfizer and Moderna are the first FDA approved vaccines to use mRNA.
- Novavax was one of the original participants in the U.S. government’s race to develop a Covid vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed.
The Food and Drug Administration has authorized Novavax’s two-dose vaccine for adults ages 18 and over, the fourth Covid shot to get emergency approval in the U.S. since the pandemic began.
The FDA decision comes weeks after its committee of independent vaccine experts voted overwhelming in favor of Novavax’s shot in early June, after an all-day public meeting in which they weighed data on the vaccine’s safety and its effectiveness at preventing illness from Covid.
The Centers for Disease Control and Prevention still needs to sign off on Novavax’s vaccine before pharmacies and other health-care providers can start administering shots. FDA authorization of Novavax’s vaccine was delayed for weeks as the agency reviewed changes to the company’s manufacturing process.
Novavax was one of the original participants in the U.S. government’s race to develop a Covid vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed. However, the small Maryland biotech company struggled to quickly get manufacturing in place and its clinical trial data read out much later than Pfizer or Moderna.
Novavax’s shots have received FDA authorization at a time when nearly 77% of adults ages 18 and over are already fully vaccinated. However, 27 million adults still have not gotten a single shot yet. Dr. Peter Marks, a senior FDA official, said Novavax’s vaccine would potentially appeal to unvaccinated people who would prefer a shot that is not based on the messenger RNA technology used by Pfizer and Moderna.
How Novavax is different
The Novavax shot is based on more conventional protein technology used for decades in hepatitis B and HPV vaccines, while Pfizer and Moderna are the first FDA approved vaccines to use mRNA.
Pfizer and Moderna’s vaccines use mRNA, a molecule encoded with genetic instructions, to tell human cells to produce copies of a virus particle called the spike protein. The immune system responds to these copies of the spike, which prepares the human body to attack the actual virus.
Novavax makes copies of the virus spike…
Read the full article at: www.cnbc.com
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