With no evidence to support the claim that 10 children died due to COVID-19 vaccines, experts unpack the impact of CBER chief Vinay Prasad’s leaked vaccine memo.
Center for Biologics Evaluation and Research chief Vinay Prasad made an explosive claim last week in an internal FDA memo: that the deaths of 10 children could be linked to COVID-19 vaccinations.
Though Prasad did not provide evidence to support the claim, it had immediate consequences at the markets for mRNA biotechs Moderna and BioNTech, while experts worried about Prasad’s lack of transparency and unilateral promises he made in the memo to alter vaccine policy around not only COVID-19, but influenza and pneumonia as well.
“After years of working at the FDA I’ve never seen a memo like that,” Peter Lurie, president of the Center for Science in the Public Interest and a former associate commissioner at the FDA, told BioSpace. “It’s a screed that veers into things of no clear relevance whatsoever.”
Lurie and others questioned Prasad’s use of the Vaccine Adverse Events Reporting System (VAERS), a public surveillance program for reporting side effects after vaccinations, to reach his conclusions. The leaked memo also displayed a persistent lack of transparency at the FDA, they said. Prasad emphasized in the memo that while he welcomed dissenting opinions, he expected these to be raised behind closed doors—while also offering resignation as an option for those not willing to comply with these terms.
Moderna’s shares, already down more than 40% year to date, were down 7% to $24.16 at the close of trading Monday.
Clarity Lacking
In his six-page memo, entitled “Deaths in children due to COVID-19 vaccines and CBER’s path forward” and published Saturday by The Washington Post, Prasad did not provide specific data to support the claim that at least 10 children had died from a COVID vaccine, only saying that an investigation had found the cases in the VAERS.
Prasad vowed to change the nation’s regulations around not only COVID vaccinations but the flu and pneumonia vaccines as well.
Tracy Beth Høeg, a known “COVID contrarian” and advisor to FDA commissioner Marty Makary, led the investigation into VAERS reports of children who died after receiving a COVID-19 vaccine, according to the memo. Prasad did not offer further details such as which manufacturers are implicated or when the deaths took place.
“He gives you no data to support that surprising assertion; he just puts it out there,” Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told BioSpace. “When you make a sensational claim like that, a frightening claim like that, at the very least, you owe it to the public to provide the evidence.”
Lurie wondered about the criteria Prasad and Høeg used to determine whether vaccinations were involved in the reported deaths. Adverse events reported to VAERS are unsubstantiated, he noted, and the FDA typically follows up with people who submitted those reports to gain more information. It’s not clear that Høeg or the Office of Biostatistics and Pharmacovigilance (OBPV), which Prasad asked to investigate an initial 96 reports, did that, Lurie said.
In his memo, Prasad also disparaged the data used to approve COVID-19 vaccines, saying that observational cohorts and case control data “have notorious methdologic [sic] biases” without elaborating on what those biases were.
Lurie argued that “those data are usually from sources—clinical trials, people presenting to emergency rooms, etc.—considered preferable to VAERS reports.” He suggested that Prasad’s memo is an “elevation of poor-quality data” and an attempt at “poking holes” in the traditional cohort and clinical trial data.
“I can’t imagine this in a prior era at FDA,” Lurie said.
Dorit Reiss, professor of law at UC Law San Francisco, agreed. “He’s expressly not doing cost/benefit analysis, even though it’s his job,” she said. “This is a bad way to do policy” that demonstrates Prasad’s lack of experience as a regulatory leader, Reiss added. “Essentially, he’s announcing that he’s making changes by fiat.”
Rocky Market Waters
With experts questioning the factual basis of Prasad’s assertions, the market responded negatively—in particular to the threat of regulatory changes for vaccines more broadly.
With Moderna’s shares down Monday, shares of fellow vaccine maker BioNTech also dipped 3.9% to $98.44 on Monday.
The leaked FDA communication is the latest hit to a vaccine industry that has been battered by headwinds this year. Since Robert F. Kennedy Jr. stepped into his role as Secretary of Health and Human Services in February, anti-vaccine rhetoric has dominated conversations among the CDC’s vaccine advisory committee—which Kennedy revamped this summer—and the FDA has issued narrowed approval guidelines for vaccines. Major vaccine makers like Pfizer, Merck, GSK and Sanofi have all reported declining sales as vaccine sentiment shifts.
Moderna, already facing prolonged headwinds as executives try to rewrite the famed biotech’s story post-pandemic, was particularly pressured, William Blair wrote in Monday.
“We see further headwinds towards [Moderna’s] declining COVID-19 franchise alongside further negative sentiment that this memo and subsequent actions may generate,” the analysts wrote.
The William Blair group specifically wondered about Moderna’s updated trivalent flu vaccine, for which recent Phase III data showed a 26.6% efficacy improvement over a previous generation shot. That trial is a head-to-head active-controlled trial, testing over 40,000 people, “which we believe is high-quality evidence,” William Blair wrote. But Prasad’s memo suggests there could be fresh scrutiny from CBER as the trial also reported an increased incidence of adverse event. While there were no recorded cases of myocarditis, the company did report fatigue, headaches and myalgia.
