FDA gets closer to clearing Novavax vaccine

June 8, 2022

This vaccine does indeed fill some unmet needs.

Dr. Michael Nelson of the University of Virginia on the FDA advisers’ vote to formally recommend the Novavax COVID-19 vaccine. The vaccine is made with more traditional vaccine technology compared to the Pfizer and Moderna versions.

Why It Matters: Advisers to the FDA recommended approval of the Novavax vaccine, which is considered a more “traditional shot” (AP). The FDA typically follows the panel’s guidance, but no exact timeline exists about when the FDA would formally approve the vaccine and make it available here in the U.S. (it could be weeks).

  • Background: Novavax is a protein-based vaccine that does not use the same mRNA vaccine technology found in the Pfizer and Moderna shots. Protein-based vaccines have been used for decades to address viruses such as hepatitis and shingles. Here’s a good source with a graphic to see how they work.
  • What the data says: Large studies covering about 40,000 participants found the Novavax vaccine was approximately 90% effective. However, the studies were conducted earlier in the pandemic when there were fewer variants. Out of the 40,000 trial participants, there were six reported cases of heart inflammation.
  • “My conditional vote ‘yes’ is based on my expectation that the FDA will review the totality of the data that will be available to them, including of data that we didn’t see today, to inform their authorization decision,” said Dr. Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation and a temporary voting member on the FDA advisory committee. He abstained from the vote while the other 21 members unanimously voted yes.
  • Why has it taken so long to get approval? Part of the delayed vaccine approval process can be attributed to problems with Novavax manufacturing facilities and less access to resources (compared to bigger names like Pfizer and Moderna). The Novavax vaccine is already available in other countries, including Canada, Australia, India, and some European countries, and has been cleared for use by the WHO.

FDA advisors back Novavax COVID shots as 4th US option (Associated Press)

FDA advisers vote to recommend Novavax Covid-19 vaccine (Politico)

by Jenna Lee,