The agency approved the vaccine for use in adults aged 65 years and older, as well as in individuals aged 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
Pfizer Inc. (PFE) and BioNTech SE (BNTX) said on Wednesday that the U.S. Food and Drug Administration has approved the application of its LP.8.1-adapted monovalent COVID-19 vaccine for use in senior adults as well as in younger individuals who are at risk of severe outcomes from the infection.
The agency approved the vaccine for use in adults aged 65 years and older, as well as in individuals aged 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
The companies said that the approval is based on a body of evidence supporting the safety and efficacy of the vaccine, including clinical trial data supporting approval for children 5 through 11 years of age.
On Stocktwits, retail sentiment around PFE trended within ‘neutral’ territory over the past 24 hours while message volume stayed at ‘low’ levels.
Meanwhile, sentiment around BNTX stayed within ‘bullish’ territory, accompanied by ‘high’ levels of retail chatter.
The 2025-2026 COVID-19 vaccine formulation targets the SARS-CoV-2 sublineage LP.8.1, in line with FDA guidance, the companies said. The companies added that the vaccine will begin shipping immediately and be available in pharmacies, hospitals, and clinics across the U.S. in the coming days.
Earlier in the day, U.S. Health Secretary Robert F. Kennedy Jr. stated in a post on X that the FDA has now granted full marketing authorization for certain COVID-19 vaccines targeting higher-risk groups. Moderna’s (MRNA) shot has been authorized for individuals six months and older, Pfizer’s (PFE) for ages five and up, and Novavax’s (NVAX) for ages 12 and above, all of whom are at higher risk, he said.
“The American people demanded science, safety, and common sense,” Kennedy said.
Moderna confirmed the news and said that the FDA has approved its 2025-2026 formulas for Spikevax and mNEXSPIKE, targeting the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. The updated vaccines are expected to be available in the coming days, it said.
While Spikevax is now approved in adults over 65 and in people aged 6 months through 64 years at high risk, mNEXSPIKE is approved for individuals 12 through 64 years of age at high risk and all adults over 65, the company said.
While PFE stock is down by 6% this year, BNTX stock is down by 9%.
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