The Food and Drug Administration’s plans to tighten vaccine approvals are impacting these stocks

A report suggesting that vaccine approvals could become more stringent is weighing on shares of major vaccine makers.

Moderna (MRNA), Novavax (NVAX), BioNTech (BNTX), and Pfizer (PFE) all fell on Monday, following a report that an internal FDA memo last week suggested new regulatory measures.

An email to staff from Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, said data from 2021 to 2024 showed that at least 10 children died “after and because of receiving the coronavirus vaccination.” New York Times I reported late last week. Prasad also outlined plans in the email to propose a set of new oversight and review processes for vaccines, without naming any specific vaccine maker, according to the report.

The memo from Prasad, who was appointed in May after the surprise resignation of Peter Marks over disagreements with Health Secretary Robert F. Kennedy Jr., has heightened expectations that vaccine makers may face an increasingly difficult regulatory environment.

The Department of Health and Human Services, which oversees the US Food and Drug Administration, did not respond to this question Investopedia Comment requested in time for publication.

William Blair analysts told clients in a note on Monday that they expect new regulatory restrictions to increase headwinds for Moderna, along with Pfizer and BioNTech.

Moderna, which got the bulk of its revenue from its coronavirus vaccine in the third quarter, was among the biggest fallers on the S&P 500 on Monday afternoon, with its shares falling nearly 7%. BioNTech stock fell nearly 5%, while Pfizer stock fell about 2%.