MRNA, PFE Stocks Jump Despite FDA's Stricter Standards for COVID-19 Shots

Shares of prominent COVID-19 vaccine-makers Moderna MRNA, Pfizer PFE and BioNTech BNTX rose yesterday after the FDA issued new guidance for COVID-19 vaccine boosters.

FDA’s New Requirements for COVID-19 Vaccines

Although the agency continues to approve boosters based on immune response data for adults 65 and older, it has tightened the standards for individuals aged 6 months to 64 years. Those at high risk within this age group remain eligible under the immunogenicity-based standard, but healthy individuals will now require evidence from randomized placebo-controlled clinical studies demonstrating real-world benefit.

As part of the post-marketing requirements, vaccine-makers seeking approval for use in high-risk populations must also conduct a randomized, placebo-controlled study in healthy individuals aged 50 to 64. Per the FDA, this age group presents a key area of scientific uncertainty and “global equipoise” around the benefits of repeated annual boosters.

The agency stated that the preferred primary endpoint for such clinical studies will be symptomatic COVID-19, while secondary endpoints should include severe disease, hospitalization and death.

Vaccine Stock Rise

Shares of several vaccine makers, including Moderna, BioNTech and Pfizer, surged on Tuesday. Though the revised policy restricts booster eligibility for healthy individuals under 65, it also signals long-term demand by reaffirming vaccine access for a substantial high-risk population.

Moderna and BioNTech were the biggest gainers from this surge, soaring 6% and 4%, respectively, on Tuesday. Pfizer stock climbed over 2%. Investor optimism was likely driven by the FDA’s estimate that 100 to 200 million Americans, including seniors and individuals with underlying conditions, remain eligible for yearly COVID-19 boosters.

The policy shift comes amid persistently low uptake of COVID-19 boosters in recent seasons. According to the CDC, fewer than 25% of Americans received boosters in each of the past two years. The vaccine uptake was especially low among children under 12 (below 10%) and healthcare workers; fewer than one-third participated in the 2023-2024 fall program.

Per the FDA, the hesitancy in COVID-19 immunizations is also affecting other key immunization programs, including the measles–mumps–rubella (MMR) vaccine. Against this backdrop, the agency’s updated framework aims to restore confidence in vaccines by requiring stronger evidence for booster use in healthy populations while maintaining protection for those at the highest risk.

The updated framework also aims to align U.S. policy with the global consensus, which generally limits routine booster recommendations to older adults and those at higher risk, rather than adopting a “one-size-fits-all” approach.

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This article originally published on Zacks Investment Research (zacks.com).

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