FDA Approves Updated COVID-19 Vaccines but With Restrictions

Yesterday, the FDA approved updated COVID-19 vaccines from Pfizer PFE, Moderna MRNA and Novavax NVAX for the 2025-26 vaccination season. These shots are designed to target the LP.8.1 strain of the virus.

FDA Removes Mandate Requirement of COVID-19 Vaccines

Unlike the past few years, when the FDA granted blanket approvals for use of COVID-19 vaccines across the general population, this time the agency restricted access to high-risk groups. Health secretary Robert F. Kennedy Jr. posted on X that the vaccines will be made available to those patients “who choose them after consulting with their doctors.”

These changes were expected after the FDA had previously issued guidelines that tightened the standards for using COVID-19 vaccines earlier this year. Under the new policy, all vaccines are cleared for adults aged 65 and older. However, for those under 65, the vaccines are permitted only for individuals with underlying conditions that raise the risk of severe COVID-19.

Company-Specific Approvals

The FDA cleared Moderna’s two COVID-19 vaccines – the first-generation Spikevax and the recently approved next-generation refrigerator-stable version called mNexspike. While Spikevax is approved for at-risk individuals aged six months and older, mNexspike is allowed for use in those aged 12 years and older. The improved storage profile of mNexspike could help Moderna expand access outside major healthcare hubs. Shares of Moderna rose 1.5% yesterday, reflecting investor confidence in the company’s ability to retain broad coverage.

Pfizer’s Comirnaty is now approved for at-risk individuals aged five years and older. This represents a narrower label compared with previous seasons, when the vaccine was available for use in all individuals six months and older. The tighter approval was likely one reason shares of Pfizer fell nearly 1% following the decision.

Novavax’s protein-based vaccine Nuvaxovid is approved for at-risk individuals aged 12 years and older, offering the only non-mRNA alternative that may appeal to patients preferring traditional vaccine platforms. Shares of NVAX rose about 1%, likely because the approval came nearly in step with its larger peers — a contrast to prior years when the company faced longer delays.

Commercial Availability of the Updated Vaccines

PFE claims that it will begin shipping the updated formulation of Comirnaty “immediately,” while Moderna stated that its vaccines will be available “in the coming days.”

Novavax’s vaccine will be marketed by its partner Sanofi as part of an exclusive licensing deal signed last year.

Our Take

The updated framework 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.

For manufacturers, the competitive dynamics are beginning to diverge. Moderna benefits from a broad pediatric label and the improved storage profile offered by mNexspike. Pfizer, meanwhile, faces some pressure as its label narrows compared with prior years. Novavax remains a niche player but continues to differentiate itself as the only non-mRNA option.

Overall, the COVID-19 vaccine market is transitioning into a smaller but more sustainable phase, where product differentiation and targeted access will play a larger role in shaping long-term opportunities for Pfizer, Moderna and Novavax.

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

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