Shares of Novavax NVAX were down 19.6% on April 10 after the United States Health and Human Services (“HHS”) Secretary Robert F. Kennedy Jr., a well-known vaccine skeptic, raised concerns regarding the efficacy of the company’s protein-based COVID-19 vaccine.

In a recent interview with CBS News, the HHS Secretary raised concerns about NVAX’s COVID-19 vaccine. He stated that it employs a single-antigen approach and mentioned that it has never worked for such respiratory diseases. The HHS Secretary also said that they are now shifting the focus toward vaccines that offer a multiple-antigen approach.

NVAX Seeking Full Approval for COVID-19 Jab

NVAX’s COVID-19 vaccine has been authorized for emergency use in the United States since 2022.  The vaccine is also approved/authorized for use in multiple markets like Australia, Canada, Europe, India and Indonesia.

However, NVAX has filed a biologics license application (BLA) seeking full approval of the vaccine. A decision from the FDA was expected earlier this month.

The market is speculating that the resignation of a key FDA official, Dr. Peter Marks, has been the reason for the delay in FDA’s decision on NVAX’s vaccine. Dr. Marks resigned citing irreconcilable differences with the new HHS Secretary last week.

Novavax has not received an official response from the FDA related to the status of the BLA.

The BLA was based on data from a phase III study, which showed the vaccine was safe and effective for the prevention of COVID-19.

Year to date, shares of Novavax have plunged 32.5% compared with the industry’s decline of 7.9%.

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Other Stocks That Declined

The concerns raised by the HHS Secretary in the latest interview also affected other vaccine makers in the United States. Pfizer PFE was down 3.9%, while Moderna MRNA was down 8.1% after the markets closed on Thursday.

While Novavax uses a protein-based COVID-19 vaccine, PFE and MRNA market mRNA-based COVID-19 vaccines, namely Comirnaty and Spikevax, respectively.

Kennedy Rules Out Personnel Change for Delay in NVAX Jab Approval

In the interview with CBS News, Robert F. Kennedy Jr. ruled out possible personnel changes when asked about the delay in the FDA approval of NVAX’s COVID-19 vaccine.

Notably, in his resignation letter posted by the New York Times, Dr. Marks had called out the newly appointed HHS Secretary for promoting “misinformation and lies” about the safety of FDA-approved vaccines. Several stocks in the vaccine and gene therapy space tumbled on the news.

Dr. Marks expressed strong concerns about efforts to undermine vaccine safety. He warned about the rising hesitancy toward vaccines and their consequences, citing the recent measles outbreak as an example of what happens when trust in vaccines is eroded.

Some Wall Street analysts worry that his absence could weaken the FDA’s role in ensuring timely access to safe and effective therapies, potentially adding to the challenges already facing the biotech sector.

NVAX's Zacks Rank

Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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