The FDA approves Novavax's updated Covid-19 vaccine, clearing the path for an autumn distribution.

The FDA approves Novavax's updated Covid-19 vaccine, clearing the path for an autumn distribution.
The FDA approves Novavax's updated Covid-19 vaccine, clearing the path for an autumn distribution.
  • The emergency use of Novavax's protein-based Covid vaccine was authorized by the Food and Drug Administration for individuals aged 12 and above.
  • The Novavax vaccine aims at the JN.1 subvariant of omicron, which has been spreading extensively in the U.S. since the beginning of the year.
  • A week after the FDA approved new messenger RNA shots from Pfizer and Moderna targeting an offshoot of JN.1 called KP.2, the agency made a decision regarding the matter.

On Friday, the Food and Drug Administration approved an updated protein-based Covid vaccine for emergency use in individuals aged 12 and above, opening up the possibility of competition with other vaccines such as Pfizer-BioNTech and Moderna this fall and winter.

Novavax's vaccine targets the JN.1 omicron subvariant, which is responsible for only 0.2% of cases circulating nationwide as of this week.

Novavax produces protein-based vaccines that cannot be rapidly modified to address a different strain of the virus.

The biotech company has observed that its vaccine safeguards against the dominant descendants of JN.1 in the U.S., including KP.2.3, KP.3, KP.3.1.1, and LB.1.

On Friday, the stock price of Novavax increased by more than 5%, in response to the news of its authorization. Despite this, the company did not respond to a request for comment.

The FDA has made a decision on the new round of messenger RNA shots from Pfizer and Moderna, which target KP.2, just a week after approving them. This decision comes after the agency authorized Novavax's shot last year, nearly a month after clearing vaccines from its rivals, putting the company at a disadvantage.

Officials in public health view Novavax's vaccine as a viable option for individuals who are hesitant to receive mRNA shots from Pfizer and Moderna, which employ a novel approach to vaccination by instructing cells to produce proteins that trigger an immune response against Covid. In contrast, Novavax's vaccine employs protein-based technology, a tried-and-true method that has been used in vaccinations against hepatitis B and shingles for decades.

The number of individuals who will receive a new Covid-19 vaccine during the fall and winter seasons is uncertain.

According to CDC data through early May, only approximately 22.5% of U.S. adults received the latest round of shots that were released last fall.

by Annika Kim Constantino

Business News