The restrictions on Novavax’s vaccine could portend changes at the FDA. Commissioner Marty Makary suggested last week that the agency could update its vaccine approval guidelines “in the coming days.”
More than a month after missing its target decision deadline, the FDA has finally approved Novavax’s next-generation COVID-19 shot—but with notable restrictions on its use.
Unlike Moderna’s Spikevax and Pfizer/BioNTech’s Comirnaty—which have full approvals and can be used in patients aged 12 years and older without limitations—Novavax’s Nuvaxovid is indicated for all seniors aged 65 years and older, and in adults 12 through 64 years with “at least one underlying condition that puts them at high risk for severe outcomes from COVID-19,” as per the FDA’s Friday approval letter.
The FDA last month failed to release its verdict for Nuvaxovid on April 1, the target action date set under the Prescription Drug User Fee agreement with Novavax. The user fee program allows the regulator to collect payments from drug sponsors in exchange for meeting certain quality standards, including a timely review process.
At the time, Politico reported that deputy commissioner Sara Brenner made the unusual move of directly intervening in the review of Novavax’s vaccine application. It is not clear why Brenner stepped in, but weeks after announcing the delay, Novavax revealed that the FDA was asking for a post-marketing commitment to collect additional clinical data for the vaccine.
Novavax agreed and the regulator in its approval letter on Friday enumerated four such post-marketing studies, including safety trials in those aged 12 years and older, with a particular focus on cardiovascular events, and in high-risk seniors 50 through 64 years.
Novavax’s approval comes on the heels of much discussion within the Department of Health and Human Services about changes to approval requirements and recommendations for COVID-19 vaccines.
Last Thursday, FDA Commissioner Marty Makary announced that the agency will update its framework for approving vaccines “in the coming days,” as per various media reports. The FDA has not yet provided further clarity on what these changes might be, but Makary, speaking at the Food and Drug Law Institute Annual Conference, said that “we want to create a framework for vaccine makers that they can use so they have a predictable FDA,” according to reporting from The Independent.
And in April, HHS Secretary Robert F. Kennedy Jr. signaled his intention to remove COVID-19 vaccines from the U.S. Centers for Disease Control and Prevention’s immunization guidelines for children, following discussions that month by the CDC’s Advisory Committee on Immunization Practices (ACIP) to switch to a risk-based immunization recommendation. The ACIP will meet again next month to vote on the issue.
Meanwhile, citing people familiar with the situation, The Wall Street Journal reported last last week that the Trump administration is planning to narrow COVID-19 vaccine recommendations, in particular for pregnant women, teenagers and children, “around the same time it launches a new framework for approving vaccines.”
