Shares of major vaccine manufacturers including Moderna, Novavax, BioNTech, and Pfizer experienced a downturn following a report suggesting imminent stricter regulations for vaccine approval. An internal Food and Drug Administration (FDA) memo, reportedly issued last week, set off the alarm.
Reportedly, Vinay Prasad, the director of the FDA’s Center for Biologics Evaluation and Research penned an email to staff indicating that from 2021 to 2024, at least 10 children died post receiving COVID-19 vaccination. The New York Times revealed these details last week, adding that Prasad, appointed in May after Peter Marks resigned due to disagreements with Health Secretary Robert F. Kennedy Jr., also stated intentions to advocate various new vaccines oversight and review methods. The specific vaccine manufacturers, however, were not named in the email.
These revelations have stoked anticipation that vaccine manufacturers may soon be navigating a progressively stringent regulatory landscape. The Department of Health and Human Services, under which operates the FDA, did not provide a comment to an Investopedia request before the time of publication.
If review procedures become more rigorous, vaccine manufacturers could find it arduous to complete trials, produce treatments, and launch them in the marketplace. Moderna, Pfizer, and BioNTech, in particular, could face additional challenges due to these restrictions, as noted by William Blair analysts in a Monday client note.
Moderna, garnering a majority of its Q3 revenue from its COVID-19 vaccine, was amongst the largest S&P 500 decliners on Monday afternoon, with shares falling close to 7%. BioNTech also experienced a dip, dropping around 5%, while Pfizer's shares dropped about 2%.