Vaccine Stocks Fall on Reports FDA Will Allege Link Between Covid-19 Shots and Child Deaths

An assistant conducts cancer vaccine research in the lab at the Moderna headquarters in Cambridge, Mass. (Adam Glanzman/Bloomberg)

Key Points

About This Summary

• FDA officials will reportedly present data suggesting Covid-19 shots are linked to 25 child deaths at a meeting next week.
• Vaccine stocks declined following reports of the FDA presentation, with Moderna down 7.2% and Pfizer down 3.5%.
• Trump’s health secretary, Robert Kennedy Jr., has reworked vaccine regulations and faced criticism for limiting access.

Vaccine stocks were tumbling on Friday, after multiple outlets reported that Food and Drug Administration officials plan to make the case at a meeting next week that the Covid-19 shots are linked to the deaths of 25 children.

Reports from NBC News and the Washington Post claimed that the FDA officials will present data from a large self-reported database of adverse reactions to vaccines known as VAERS, or the Vaccine Adverse Event Reporting System, which is managed by the FDA and the Centers for Disease Control and Prevention.

Moderna, which makes one of the widely used Covid-19 shots, said that U.S. and global regulators “have not identified any new or undisclosed safety concerns in children or pregnant women” tied to the company’s shot, Spikevax. It said that more than a billion doses of the shot had been distributed worldwide.

Pfizer, the manufacturer of the other widely used Covid-19 shot in the U.S., didn’t immediately respond to a request for comment.

The reports seemed to be taken as confirmation of the Trump administration’s intentions to heighten its campaign against the vaccine sector, and vaccine stocks were down sharply on Friday afternoon. Shares of Moderna were down 7.2%, while shares of Pfizer were down 3.5%. Pfizer’s partner BioNTech was down 8.5%, while Novavax, which makes a competing Covid-19 shot, was down 3.7%.

Vaccine stocks with no direct exposure to the Covid-19 market were also falling. Valneva, a French vaccine developer, was down 3.1%, and GSK, which makes the shingles shot Shingrix and other vaccines, was down 1.9%. Sanofi, which sells flu shots, was down 0.7%.

Trump’s health secretary, Robert F. Kennedy Jr., is a longtime critic of vaccines, who in recent months has reworked much of the vaccine regulatory infrastructure under his agency’s control. In a fiery Senate hearing last week, Kennedy faced criticism from both Republicans and Democrats for limiting access to vaccines. The reports on Friday suggest he wasn’t cowed, and doesn’t intend to ease up his campaign.

NBC, the Washington Post, and the New York Times all said Friday the FDA officials plan to make their presentation at next week’s meeting of the CDC’s Advisory Committee on Immunization Practices, the influential group of outside experts that determines how vaccines are used in the U.S. Earlier this year, Kennedy fired all the members of the committee, and appointed a handpicked group in their place that is stacked with critics of the Covid-19 vaccines.

The FDA’s commissioner, Dr. Marty Makary, appears to have hinted at the plans for next week’s presentation in an appearance on CNN earlier this month. “We do know at the FDA, because we’ve been looking into the VAERS database of self-reports, that there have been children who have died from the Covid vaccine,” he said. “And so we’re doing a proper investigation.”

Makary said that the agency is interviewing family members who say their children died after receiving a shot and reviewing autopsy reports. “We think the public deserves to have that information,” he said.

VAERS, the database on which the outlets said the presentation would be based, contains anecdotal reports that patients, doctors, caregivers, or third parties submit if they suspect a link between an adverse health event and a vaccination. CDC and FDA can follow up on VAERS reports, but the reports themselves are unvetted.

One vaccine expert contacted by Barron’s was skeptical of any report based solely on VAERS data. Dr. Paul Offit, a former ACIP member and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said that it’s impossible to tell what the association is between vaccines and the adverse events reported to VAERS. “It’s the problem with small numbers in large databases,” he said. “If there’s this evident pathogenesis that explains it, great. I really doubt that. We’ll see.”

Asked for comment on the media reports on Friday, U.S. Department of Health and Human Services communications director Andrew Nixon said that CDC and FDA staff regularly look at VAERS data. “Those reviews are being shared publicly through the established ACIP process,” he said. “Until that is shared publicly, any of this should be considered pure speculation.”

ACIP is expected to vote during next week’s meeting on recommendations for who should get an updated Covid-19 vaccine this fall. Their vote will determine how insurers cover the shots, and will have substantial influence over who has access to them.

ACIP has been widely expected to issue narrow recommendations for the use of the shots this year, following on the FDA’s decision late last month to approve them only for adults older than 65, and for younger people with a condition that puts them at high risk for serious illness due to a Covid-19 infection.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com