The US Food and Drug Administration has fully approved Novavax’s COVID-19 vaccine. But it is done with uncommon limitations. In contrast to its rivals Pfizer and Moderna, Novavax is now only allowed to provide its vaccine to people 65 and over—or individuals 12 to 64 with a high-risk medical condition.
This move sharply limits its scope, even though it previously was used under emergency authority for anyone 12 and above.
Conventional Vaccine, Restricted Use
Only a single protein-based COVID-19 vaccine is made by Novavax, which can be found in the US. So far, the FDA had approved it under emergency use for all age groups. But at the end of Friday, the agency narrowed the criteria. It now completely approves the vaccine only for older people or those with serious health conditions.
In the meantime, Pfizer and Moderna vaccines are still fully authorized for all individuals 12 years and older. They also have approval for children as young as 6 months. This FDA action reflects a clear change in vaccine policy—perhaps caused by the Trump administration’s current COVID-19 position.
Political Influence Behind the Scenes
The FDA Friday letter did not clarify why it set these tight restrictions. Yet, current Health Secretary Robert F. Kennedy Jr. and other Trump administrators have long expressed skepticism about vaccine safety. Their presence could have influenced the decision of the agency.
Informants said reporters the FDA initially intended to give unrestricted approval to Novavax by April 1. But at the last minute, the agency reversed field. It requested the company to carry out another post-approval test—an unprecedented move after full licensure.
New Trials Ordered Post-Approval
The FDA asked Novavax to conduct several follow-up studies. One will look at potential connections between the vaccine and cardiac conditions. The other will determine the benefit of ongoing vaccination in adults between 50 and 64 without high-risk health conditions.
Novavax CEO John C. Jacobs welcomed the limited approval. He added that older people and those with chronic disease are most likely to take seasonal COVID-19 vaccines.
This important milestone shows our devotion to these groups,” he stated.
Outlook for US Vaccine Policy
In the next month, CDC advisors will weigh whether annual COVID-19 shots should persist in all Americans—or merely in vulnerable populations. The Novavax approval indicates the Trump administration might have already spoken.
For Novavax, the approval lends credibility—but to a whole lot fewer qualifying recipients. For Americans, it marks a change in how the government might proceed with future COVID-19 vaccination plans.
