US EditionFDA Approves COVID-19 Vaccines only for ‘High Risk’ People
The FDA approved Pfizer-BioNTech's LP.8.1-adapted monovalent COVID-19 vaccine for fall 2025 to protect 65+ adults and high-risk individuals aged 5-64, based on safety and efficacy data.
- On August 27, 2025, the U.S. Food and Drug Administration approved Pfizer and BioNTech's LP.8.1-adapted monovalent COMIRNATY for adults 65 years and older and individuals ages 5 through 64 with at least one underlying condition, with shipping beginning immediately for the fall 2025 season.
- Based on trial and laboratory evidence, regulators recommended the LP.8.1 sublineage for fall 2025 vaccinations after preclinical models showed improved immune responses against multiple SARS-CoV-2 sublineages.
- In clinical testing, COMIRNATY showed 9.3% higher efficacy in a phase 3 trial of over 11,000 participants and 5 billion doses were distributed globally; safety info notes myocarditis and pericarditis.
- The CDC Advisory Committee on Immunization Practices will review the FDA decision, while Health and Human Services Secretary Robert F. Kennedy Jr. said vaccines remain available after medical consultation, though new restrictions may affect insurance coverage and require patients to demonstrate high-risk status.
- Public health leaders warned that narrowing vaccination guidance could reduce access, as the change removed some groups, revoked the emergency use authorization for children under 5, and may impact pharmacies and drugstore vaccination sites amid CDC personnel changes.
46 Articles
46 Articles
FDA approves updated covid vaccines, but with severe new limits
On Wednesday, the FDA approved the new round of COVID-19 vaccines from Pfizer, Moderna, and Novavax for use by seniors over the age of 65. But for anyone younger than that, the FDA approval only mentions people who have “at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.” It also removed one option for children entirely, revoking the Pfizer vaccine’s emergency use authorization for children under 5.…
By Jamie Gumbrecht, Deidre McPhillips and Brenda Goodman, CNN The U.S. Food and Drug Administration (FDA) approved up-to-date vaccines against covid-19, but for a smaller group: adults 65 years of age or older and younger people at high risk of the virus. “The FDA has now issued a marketing authorisation for those at greatest risk: Modern (6 months later), Pfizer (5+) and Novavax (12+). These vaccines are available to all patients who choose the…
Washington Top News
The U.S. Food and Drug Administration (FDA) has approved updated COVID-19 vaccines for a smaller group: adults 65 and older and younger people at high risk from the virus. “The FDA has now issued a marketing authorization for those at greatest risk: Moderna (6 months and older), Pfizer (5+), and Novavax (12+). These vaccines are available to all patients who choose them after consultation with their physicians,” U.S. Secretary of Health and Huma…
Coverage Details
Bias Distribution
- 84% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium
