Vaccine Stocks Fall After FDA Plans to Impose Stricter Vaccine Rules

Shares of prominent vaccine makers Moderna MRNA, BioNTech BNTX, Pfizer PFE, Novavax NVAX and Vaxcyte PCVX fell on Monday after the FDA announced plans to impose strict new vaccine requirements.

What’s Going On?

Per several third-party articles, Dr. Vinay Prasad — who heads the FDA’s Center for Biologics Evaluation and Research (CBER) — reportedly sent an internal memo to staffers on Friday acknowledging that “COVID-19 vaccines have killed American children.” The contents of this memo were initially revealed by a PBS NewsHour correspondent in a social media post.

In this memo, Dr. Prasad claimed that at least 10 children had died “after and because of receiving” COVID-19 vaccines. Though he did not provide any details of the evidence supporting this data, Prasad linked these deaths to myocarditis (an inflammation of the heart muscle). The CBER head believes that the “true numbers” of deaths due to COVID-19 vaccinations could be even higher and accused his predecessors of ignoring safety concerns in the past.

Apart from COVID-19 shots, the memo also mentioned that Prasad intends to look into the guidelines for other vaccines. While he plans to revise the annual influenza vaccine framework, he also raised questions about giving multiple vaccines at the same time. The memo reportedly stated that the FDA would also no longer authorize vaccines for use in pregnant women without stronger supporting data and stricter safety requirements.

The contents of this memo were backed up by FDA Commissioner Marty Makary in an interview on Saturday, who stated that the information about these deaths will be made available soon. He also mentioned that, going forward, the FDA will not “rubber-stamp” new vaccines without evidence supporting the clinical benefits of the same.

Several vaccine experts have criticized the contents of the memo and the FDA Commissioner’s statements, stating that more evidence is needed to support such claims. Some experts even believe that the agency officials are misusing the information, which was gathered from the federal Vaccine Adverse Event Reporting System (VAERS). While the VAERS database collects reports of adverse events following vaccinations, it does not establish cause and effect on its own.

Vaccine Makers in Jeopardy?

Shares of several vaccine-makers declined following the news. While Moderna fell 7% on Monday, BioNTech was down about 6%. Pfizer slipped nearly 2%. Novavax was down 5% while Vaxcyte fell more than 8%.

Investors expressed concern that stricter regulatory attention could give an impetus to anti-vaccine sentiment in the country. The memo and FDA Commissioner’s comments come ahead of an upcoming meeting of a CDC advisory committee, scheduled for Dec. 4-5, 2025 (Thursday and Friday), to discuss the childhood vaccine schedule, as well as the hepatitis B shot.

While the FDA decides whether a vaccine can be marketed, the CDC determines who should receive it and under what conditions.

Our Take

The latest developments are not entirely surprising given the current leadership at the Department of Health and Human Services under Robert F. Kennedy Jr., a well-known vaccine skeptic. This news also aligns with several third-party articles, which had previously reported in September that health officials were planning to use data filed with VAERS to build a case linking COVID-19 vaccines to pediatric deaths.

The drastic changes in vaccine policies and usage have raised concerns among industry leaders, who are raising questions about the independence of public health decision-making. Earlier this year, RFK Jr. dismissed all members of a key CDC advisory committee and replaced them with individuals who reportedly share his views on vaccines. Prasad concluded the memo by explicitly asking those who disagree with his views at the FDA to resign.

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

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