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 Novavax’s COVID-19 vaccine is not effective, his first comments since regulators missed a deadline to approve the shot.

“We’re looking at that vaccine. It is a single antigen vaccine, and for respiratory illnesses, the single antigen vaccines have never worked,” Kennedy told CBS in an interview released on April 9.

The Food and Drug Administration (FDA) was supposed to decide whether to grant Novavax’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 “any delays to the FDA’s independent review process for the Novavax are a result of scientific review to ensure safety and efficacy.” 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 FDA’s office in charge of reviewing vaccines.

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

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

“We have not yet received an official response from the U.S. Food and Drug Administration regarding the status of our BLA,” the company said.

The other two COVID-19 vaccines that are cleared by the FDA are made by Moderna and Pfizer. Both are built on messenger ribonucleic acid technology, or mRNA, platforms.

The FDA in 2024, in its most recent action on the vaccines, cleared updated COVID-19 vaccines from all three manufacturers, stating that older versions were not as effective against newer COVID-19 strains. Novavax’s updated shot received emergency authorization, as opposed to approval.

Novavax shares dropped from $6.95 on April 9 to $5.12 on April 10, though the price had partially rebounded to $5.61 on Friday.

Original News Source Link – Epoch Times

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