BioNTech stock skidded Wednesday after the Food and Drug Administration ended its broad authorization of Covid vaccines in the U.S.
The news comes alongside the approval of BioNTech's Pfizer-partnered Covid shot. The booster aims to block the prevalent LP.8.8 strain of the Covid-causing coronavirus. It's approved for people age 65 and older, and for people age 5 through 64 at high risk of developing severe Covid.
Robert F. Kennedy Jr., who heads up the Department of Health and Human Services, in a post on the social media platform X, said the booster shots will be available to all patients "who choose them after consulting with their doctors." It's unclear how easily patients will access those shots, and whether insurers will pay for them.
Kennedy says he promised to end Covid vaccine mandates while keeping shots available to those who want them, demand placebo-controlled studies from vaccine makers and end the Covid emergency.
"The American people demanded science, safety and common sense," he said. "This framework delivers all three."
BioNTech stock slipped 1.7% to 103.01, while Pfizer stock rose a fraction to 25.07. Shares of Covid vaccine maker Moderna closed 1.5% higher at 25.10, while Novavax reversed earlier losses and climbed 1.1% to close at 7.58.
BioNTech Stock: Uptick In Covid Cases
The news comes amid an uptick in summer Covid cases. According to the Centers for Disease Control and Prevention, positive Covid tests reported to the agency climbed nearly 10% over the week ended Aug. 16. There was also a 1.2% rise in emergency department visits related to Covid.
Pfizer and BioNTech say their Covid booster will begin shipping immediately to pharmacies, hospitals and clinics across the U.S. To date, there have been more than 5 billion doses of the shot shipped across the globe, the companies said in a news release.
But uptake could be flimsy with a limited pool of eligible patients.
In the third and fourth quarters — the big sales periods for Covid shots — analysts polled by FactSet expect Pfizer to report a combined $4.03 billion in sales for the booster shot. That's down from 16% from the same six months in 2024 and 42% from the same period in 2023.
Lower Covid/Flu Vaccine Forecasts
Leerink Partners analyst Mani Foroohar recently cut his expectations for sales in the upcoming flu and Covid season, noting lower vaccine trends and regulatory uncertainties due to viewpoints from FDA leaders on messenger RNA vaccines. Pfizer and BioNTech's Comirnaty as well as both Covid shots from Moderna use messenger RNA technology.
"We note that for most mRNA vaccine manufacturers, the development strategy of both a combo COVID/Flu vaccine and a standalone flu vaccine remains unclear, and we expect regulatory events, clinical data, and commercial contracting dynamics to drive strategic decisions," he said in a client note.
Foroohar lowered his price target on Moderna stock to 15 from 18. Leerink's Daina Graybosch still rates BioNTech stock an outperform.
Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.
