Health Secretary Shares Concerns About Efficacy of Novavax COVID-19 Vaccine After FDA Delay

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Robert F. Kennedy Jr. said the vaccine is not effective.

Health Secretary Robert F. Kennedy Jr. said in a new interview that Novavaxโ€™s COVID-19 vaccine is not effective, his first comments since regulators missed a deadline to approve the shot.

โ€œWeโ€™re looking at that vaccine. It is a single antigen vaccine, and for respiratory illnesses, the single antigen vaccines have never worked,โ€ Kennedy told CBS in an interview released on April 9.

The Food and Drug Administration (FDA) was supposed to decide whether to grant Novavaxโ€™s license application by April 2, the Maryland-based company has said. The firm makes one of the three COVID-19 vaccines available in the United States, and the only one that does not use messenger ribonucleic acid technology.

The FDA has not said why the deadline passed without a decision.

An official with the Department of Health and Human Services (HHS), which Kennedy heads, previously told The Epoch Times in an email that โ€œany delays to the FDAโ€™s independent review process for the Novavax are a result of scientific review to ensure safety and efficacy.โ€ The FDA is part of HHS.

Kennedy was asked in the new interview if the delay stemmed from a lack of personnel, after the departure of Dr. Peter Marks, among others. Marks led the FDAโ€™s office in charge of reviewing vaccines.

โ€œWe are actually shifting our priorities to multiple antigen vaccines. And NIH is already working on a number of those,โ€ Kennedy said, referring to another HHS division, the National Institutes of Health.

In an April 10 statement, Novavax said, โ€œAs we have previously stated, we believe that our Biologics License Application (BLA) for our COVID-19 vaccine included robust Phase 3 clinical trial dataโ€ฏthat showed our vaccine is safe and effective for the prevention of COVID-19.โ€

It pointed to a clinical trial conducted by the company that recorded 14 cases of COVID-19 among vaccine recipients and 63 cases among recipients of a placebo, as well as a second trial that found the efficacy of the vaccine was 79.5 percent among adolescents.

โ€œWe have not yet received an official response from the U.S. Food and Drug Administration regarding the status of our BLA,โ€ the company said.

Byย Zachary Stieber

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