The Food and Drug Administration’s (FDA) expert vaccine advisory panel gave the green light to authorizing a fourth COVID-19 vaccine in the U.S. at their meeting Tuesday.
The Vaccines and Related Biological Products Committee (VRBPAC) at the FDA voted 21 to 0, with one abstention, to recommend authorization of Novavax’s COVID-19 vaccine for Americans 18 years and older. The two-dose vaccine would become the fourth to be authorized in the U.S., and offer another non-mRNA alternative in addition to Johnson & Johnson’s vaccine.
A more traditional kind of COVID-19 vaccine has moved a step closer to the U.S. market. Advisers to the Food and Drug Administration voted to back shots made by Novavax for adults.https://t.co/dkf6WRgXra
— AP Health & Science (@APHealthScience) June 7, 2022
The FDA is not required to follow VRBPAC’s recommendation and grant emergency use authorization for the shot, although it typically does and did so for the other three vaccines recommended by the committee.
The Novavax shot has already been in use in more than 40 other countries, and some of Tuesday’s meeting attendees said during the public comment period that the FDA was too slow in moving the shot through its regulatory process. (RELATED: Fauci Admits Fight Over Travel Mask Mandate Is All About Hoarding Power)
The two-dose vaccine uses protein-based vaccine technology, differentiating itself from the primary two vaccines used in the U.S. from Moderna and Pfizer.
“We have heard in today’s VRBPAC meeting the significant support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option,” Novavax president and CEO Stanley Erck said Tuesday.
Novavax presented data to the committee showing that its vaccine was 90% effective in preventing mild and severe COVID-19 cases with a strong safety profile. However, some committee members expressed concern that the trials on the vaccine were conducted during the Alpha and Delta waves of the pandemic, and that some efficacy may be lost against the Omicron variant.