Moderna and Novavax Stocks Drop as FDA Outlines Stricter Vaccine Approvals

The FDA’s top vaccine regulator is a vocal critic of the U.S. Covid-19 response. (Leon Neal/Pool/AFP/Getty Images)

Key Points

• Vaccine maker shares decline after the FDA indicate stricter approval rules.
• An internal FDA memo linked Covid-19 vaccines to 10 child deaths reported to the Vaccine Adverse Event Reporting System.
• Dr. Vinay Prasad, FDA’s top vaccine regulator, proposed changes to the vaccine evaluation process, according to reports.

Shares of vaccine makers fell Monday after the Food and Drug Administration’s top vaccine regulator said in an internal memo that the agency would introduce stricter vaccine approval rules.

In an email to staff late last week, Dr. Vinay Prasad, who leads the Center for Biologics Evaluation and Research, linked Covid-19 shots to the deaths of 10 children reported to the Vaccine Adverse Event Reporting System between 2021 and 2024. Prasad also proposed changes to the FDA’s vaccine evaluation process, singling out flu and pneumonia vaccines as examples, according to multiple media reports on the memo.

The Department of Health and Human Services, which oversees the FDA, didn’t respond to Barron’s request for comment.

Moderna stock fell 5.5% on Monday, Novavax dropped 4%, and U.S.-listed shares of BioNTech were down 4.2%. Pfizer stock was down narrowly. The SPDR S&P Biotech exchange-traded fund dropped 1.6%.

Prasad didn’t provide details about the deaths, the children’s conditions, or the vaccines involved, reports said. The findings haven’t been made public or published in a peer-reviewed journal.

FDA Commissioner Dr. Marty Makary told Fox News over the weekend that the agency would make the information available.

“We’re not going to just rubber stamp approvals without seeing some scientific evidence,” Makary said, arguing that the FDA was too lenient with its approval process under the Biden administration.

Moderna and other pharmaceutical stocks fell in May when the FDA tapped Prasad, a vocal critic of the U.S. Covid-19 response. Health Secretary Robert F. Kennedy Jr., a vaccine skeptic, also has been critical of the messenger RNA-based Covid-19 shots made by Moderna and Pfizer.

Write to Nate Wolf at nate.wolf@barrons.com