The Food and Drug Administration said Tuesday it will limit future Covid vaccines to older and at-risk Americans. The move buoyed vaccine stocks Moderna, BioNTech and Pfizer.
In an editorial published in the New England Journal of Medicine, FDA Commissioner Marty Makary and Vinay Prasad, the agency's new director of Center for Biologics Evaluation and Research, criticized the "one-size-fits-all" approach to immunization embraced by the federal government. In comparison, other high-income countries confine vaccines to older adults and those at risk of serious illness if they contract Covid, they said.
"The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations," Makary and Prasad wrote. "We reject this view."
Going forward, companies must show their vaccines generate Covid-blocking antibodies in people age 65 and older or six months and older with at least one risk factor of serious illness. This will likely be enough to "make a favorable benefit-risk finding."
But for otherwise healthy people, the FDA expects the need for randomized, controlled studies.
Vaccine stocks surged in response. Moderna shares jumped 6.1%, closing at 27.99. BioNTech stock rose 4% at 101.72, while Pfizer shares cruised 2.3% higher to 23.52. Novavax stock slipped a fraction to 7.68, reversing an earlier gain.
Moderna, Pfizer Vaccine Sales Decline
For years, vaccine makers have updated their Covid shots to align with the most prevalent strains. This is similar to the process for annual flu shots. But Covid vaccination rates have been in decline for years. According to the Centers for Disease Control and Prevention, just 23% of adults and 13% of children received a Covid vaccine during the 2024-25 season, which ended on May 2.
Vaccine sales have also declined. Moderna, which became a household name at the peak of the pandemic, reported just $3.24 billion in sales last year, down from a record $19.26 billion in 2022. Similarly, sales of Pfizer's BioNTech-partnered Covid shot peaked at $37.81 billion in 2022. Last year, Pfizer notched just $5.35 billion in sales of the vaccine.
According to Makary and Prasad, just 100 million to 200 million Americans will have access to vaccines under the new framework.
"We simply don't know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of Covid-19 vaccine will benefit from a seventh dose," they wrote. "This policy will compel much-needed evidence generation."
Some Details Remain Vague
But Paul Offit, a vaccine expert at the Children's Hospital of Philadelphia, says the framework is vague as to who to consider high risk. Offit sits on the FDA's Vaccines and Related Biological Products Advisory Committee, which makes recommendations on the benefits and risks of vaccines.
"Is the pharmacist going to determine if you're in a high-risk group?" he said, according to the Associated Press. "The only thing that can come of this will make vaccines less insurable and less available."
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