Moderna shares hit a low after report suggests the FDA plans to tie COVID shots to child deaths

Pharma stocks took a fresh hit on Friday following a report in The Washington Post that the U.S. Food and Drug Administration reportedly plans to link COVID-19 vaccines with the deaths of 25 minors.

Moderna shares fell 7.4% Friday to their lowest level since March 2020. The drop brought the drugmaker’s year-to-date slump to more than 44%. The Cambridge, Massachusetts-based company is one of two manufacturers of approved mRNA coronavirus vaccines.

The other mRNA COVID-19 vaccine maker, Pfizer, saw its own shares fall 3.9% on Friday. Shares of its partner on the shot, BioNTech, tumbled 7.3%, while stocks in another vaccine maker, Novavax, were down 3.6%.

The pharma companies’ stock slump stands in contrast to the market as a whole, with the S&P 500 rising more than 12% this year.

FDA officials reportedly plan to present the data at an upcoming vaccine advisory panel meeting, according to the Post. The panel makes recommendations to the U.S. Centers for Disease Control and Prevention as it sets vaccine schedules and guidance, and its recommendations have historically guided insurance coverage for vaccines and state policy.

The data is apparently based on self-reported adverse events collected in a federal database called the Vaccine Adverse Event Reporting System (VAERS). The database contains unverified reports and is not designed to conclude that a vaccine caused a death. The FDA didn’t immediately respond to Fast Company’s request for comment.

Vaccine policy in U.S. shifting under new administration

U.S. Health and Human Services Secretary Robert F. Kennedy Jr. fired all of the members of the vaccine advisory panel, which is known as the Advisory Committee on Immunization Practices (ACIP). Kennedy installed seven new members who have criticized vaccines in the past. Kennedy is reportedly considering appointing seven more members to the committee who share his skepticism of COVID vaccines or the pharmaceutical industry, Politico reported. And last month, the FDA imposed new eligibility restrictions on COVID-19 vaccines that critics say has severely limited who can get the shot.

ACIP is due to meet on September 18 and September 19, and the committee is expected to discuss vaccines for COVID-19, as well as hold votes on recommendations for vaccines for measles, mumps, rubella, and varicella (MMRV) and hepatitis B, as well as COVID-19.

Pharma companies criticize restrictions on shots

Moderna’s CEO Stéphane Bancel said at a WIRED health summit that recent changes in U.S. vaccine policy represented a “step backward.”

Moderna, in a statement to Barron’s on Friday, noted that the safety of its COVID-19 vaccine is “rigorously monitored” by the company, the FDA, and regulators in more than 90 countries. Those safety systems have not identified any new or undisclosed safety concerns in children or in pregnant women, the company said.

And in a statement to Bloomberg, Pfizer said that extensive data supports the safety and effectiveness of its COVID-19 vaccine, and cited its successful administration to more than one billion adults, adolescents, and children.

Both drugmakers didn’t immediately respond to requests for comment from Fast Company.