Shares of prominent COVID-19 vaccine makers Moderna (MRNA), BioNTech (BNTX), Pfizer (PFE), and Novavax (NVAX) fell on Friday following reports that the Trump administration is preparing to link COVID-19 vaccines to the deaths of 25 children.
What’s Going On?
An article from the Washington Post (WP) stated that health officials are reportedly using the data filed with the federal Vaccine Adverse Event Reporting System ("VAERS") to build a case connecting COVID-19 vaccines to pediatric deaths. While the VAERS database collects reports of adverse events following vaccinations, it does not establish cause and effect on its own.
The report claimed that the pediatric data is expected to be referenced in a presentation later this week to an advisory committee of the Centers for Disease Control and Prevention ("CDC"), which is reviewing updated COVID-19 vaccine recommendations and insurance coverage considerations. However, the WP article noted that the presentation materials are yet to be finalized.
This announcement came just a couple of weeks after the FDA approved updated COVID-19 vaccines for the 2025-26 vaccination season. Unlike the past few years, when the FDA granted blanket approvals for use of COVID-19 vaccines across the general population, this time the agency restricted access to high-risk groups. Under the new policy, all vaccines are cleared for adults aged 65 and older. However, for those under 65, the vaccines are permitted only for individuals with underlying conditions that raise the risk of severe COVID-19.
The CDC advisory committee is scheduled to meet later this week on Sept. 18-19, 2025 (Thursday and Friday) to discuss the safety, effectiveness and clinical necessity of vaccines. While the FDA decides whether a vaccine can be marketed, the CDC determines who should receive it and under what conditions.
Future of COVID-19 Vaccine-Makers in Jeopardy
Shares of COVID-19 vaccine-makers declined following the news. Investors were concerned that renewed regulatory attention could further dampen the already slowing COVID-19 vaccine demand. Any additional concern on safety or insurance coverage may put further pressure on the long-term outlook for these companies.
Moderna and BioNTech fell more than 7% each after the WP article’s release. Pfizer and Novavax slipped nearly 4%.
Our Take
The latest developments are not entirely surprising, given the current leadership at the Department of Health and Human Services ("HHS"). The recently appointed HHS secretary, Robert F. Kennedy Jr., is a well-known vaccine skeptic. The drastic changes in vaccine policies and usage have raised concerns among industry leaders, who fear that political influence could override established scientific standards.
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, raising further questions about the independence of public health decision-making. Around the same time, a senior FDA vaccine official resigned after clashing with the HHS head over vaccine-related directives.
For companies like Moderna, Pfizer, BioNTech and Novavax, which are already dealing with declining COVID-19 revenues, the risk of a further narrowing of coverage recommendations adds to long-term challenges.
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Pfizer Inc. (PFE): Free Stock Analysis Report Moderna, Inc. (MRNA): Free Stock Analysis Report Novavax, Inc. (NVAX): Free Stock Analysis Report BioNTech SE Sponsored ADR (BNTX): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).
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