From CNBC: 2025-05-20 15:30:00

Brandon Guerrero received both a flu and Covid vaccine at CVS in California. The FDA issued new guidelines for Covid boosters, requiring stricter approval for healthy individuals. The agency wants new clinical trials to show safety and efficacy, which may limit who gets boosters each year. The FDA’s new policy emphasizes regulatory flexibility and scientific accuracy. Health and Human Services Secretary Robert F. Kennedy Jr. is making changes to immunization policy. For high-risk individuals, immunogenicity data may be enough for approval, but healthy individuals may need stronger evidence from trials. The FDA estimates 100-200 million Americans are at high risk for severe illness. Trials must show at least 30% effectiveness in preventing symptomatic Covid. Annual Covid booster updates may not be necessary, according to the FDA. The agency will encourage manufacturers to conduct trials in healthy adults after approval for high-risk individuals. The FDA argues against a ‘one-size-fits-all’ approach to Covid vaccinations, citing declining trust in vaccines and falling vaccination rates. Less than 25% of Americans have received a Covid shot in the past two seasons, including less than 10% of kids and less than 50% of adults over 75. Less than one-third of healthcare workers received updated boosters in the 2023-2024 season. The paper also mentions a decline in trust in vaccination, including for the MMR vaccine.



Read more at CNBC: FDA outlines stricter Covid vaccine approval standards