Shares of Moderna (MRNA) and other vaccine stocks tumbled Monday after a Food and Drug Administration director reportedly suggested Covid shots killed at least 10 children between 2021 and 2024.
Now, Vinay Prasad, who heads up the Center for Biologics Evaluation and Research, wants a stricter review and approval process for vaccine studies. CBER is the FDA branch in charge of, among other products, vaccines. According to media reports and analysts, Prasad issued a memo describing a link between Covid shots and death due to myocarditis, or swelling in the heart.
“Fear, confusion, but no data,” Leerink Partners analyst Mani Foroohar said in a report. Prasad “sent an inflammatory internal email highlighting findings of death due to COVID vaccines in children and (vowed) to make substantial changes to the vaccine approval and monitoring framework.”
Moderna stock tumbled more than 5% to 24.45, while shares of Pfizer (PFE) and BioNTech (BNTX) skidded a respective 1.6% and 4.6%. Moderna makes the messenger RNA-based Covid vaccines Spikevax and mNexspike, while Pfizer and BioNTech partner on mRNA-based Comirnaty.
Shares of Dynavax Technologies (DVAX), which is testing an oral Covid vaccine, tumbled 5.7%. Novavax, another Covid vaccine maker, slumped 3.9%. Dynavax’s and Novavax’s approaches don’t use mRNA technology, which some studies have suggested heightens the risk of myocarditis in boys and young men.
Moderna In Spotlight
So far, just 5.8% of children and 13.8% of adults in the U.S. have received Covid vaccines this season, William Blair analyst Myles Minter said in a report. This comes after the Centers for Disease Control and Prevention ended the universal recommendation for Covid vaccines.
“If new regulatory restrictions were to be implemented in the higher myocarditis risk population, we see further headwinds toward the company’s declining COVID-19 franchise alongside further negative sentiment that this memo and subsequent actions may generation,” Minter said.
The memo outlines an analysis from the Office of Biostatistics and Pharmacovigilance. OBPV examined 96 deaths between 2021 and 2024 following vaccination. No fewer than 10 were related to vaccination. CBER is now planning to take “swift action” following this new safety concern. The labels for the Covid vaccines already warn against the risk of myocarditis and pericarditis.
But the memo also highlights Prasad’s plan to require additional effectiveness data from pneumococcal vaccine studies. These vaccines prevent diseases like pneumonia, meningitis and other infections. Vaxcyte (PCVX) stock took that news on the nose, falling 7.4% to 45.92.
In an email to Leerink Partners analyst David Risinger, the company noted Prasad’s memo states firms must show their pneumonia vaccines reduce pneumonia and not just generate antibodies capable of tackling the virus.
“As written, this aligns with how post-marketing evidence has historically been regenerated in the pneumococcal vaccine class, where licensure has been based on established immunologic correlates of protection, with additional real-world data collected after approval,” Vaxcyte said, according to Risinger. “Our approach is aligned with other PCV developers.”
Focus On Regulations
Leerink’s Foroohar says the memo takes an “inflammatory tone,” describing “coercive and unethical Covid-19 vaccine mandates in young people.”
“We do not know how many fewer kids would have died had they been vaccinated, and we do not know how many more kids died from taking vaccines than has been voluntarily reported,” Prasad, CBER’s director, said in the memo.
Foroohar calls the memo another negative development for mRNA vaccine makers that could add to vaccine skepticism and continued U.S. vaccination declines.
CBER is now planning to make several changes to the vaccine regulatory pathway.
This includes premarket randomized trials assessing clinical goals beyond immunogenicity, or how effective vaccines are at stimulating the immune system. CBER will also no longer allow companies to use immunogenicity studies to expand the addressable population for already approved vaccines.
Moderna stock, which has climbed 16% from Nov. 20-28, saw shares hit their 50-day moving average on Friday and then tumble well below that mark on Monday.
Similarly, BioNTech shares hit a 50-day ceiling on Friday and skidded Monday. Dynavax shares are well above their 50-day and 200-day lines despite Monday’s drop. Vaxcyte shares also remained above their key moving averages despite toppling on Monday.
Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.
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