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FDA Will Limit Approval for Seasonal COVID Vaccines: What to Know
- On May 20, 2025, the FDA announced it will limit seasonal COVID-19 vaccine approvals to seniors and high-risk individuals, excluding healthy younger adults and children without new trials.
- This decision reverses prior federal policy recommending annual shots for all aged six months and older and stems from concerns over waning booster benefits and widespread natural immunity.
- The FDA released guidelines urging manufacturers to carry out extensive and prolonged studies prior to approving updated vaccines for healthier individuals, while continuing to allow expedited approval for adults aged 65 and above and younger people with certain high-risk conditions.
- An FDA vaccine leader indicated that over 100 million Americans remain eligible for booster doses, while Dr. Vinay Prasad referred to the strategy as a "reasonable compromise" that supports ongoing vaccination for high-risk groups and enables the collection of data on vaccine effectiveness in healthier individuals.
- Experts warn the policy may limit vaccine access and choice, especially for children, and could slow public health decisions, while raising concerns about potential increased vaccine hesitancy and reduced insurance coverage.
22 Articles
22 Articles
Covid-19 shots should target newer strains of JN.1 variant in 2025-26 campaign, US FDA advisers say
U.S. Food and Drug Administration advisers unanimously recommended on Thursday that COVID-19 vaccines for the 2025-26 period should target newer strains of the JN.1 variant. Read more at straitstimes.com.
Morning Greatness: FDA Restricts COVID-19 Vaccines to Older Adults, High-Risk Groups › American Greatness
Good Friday morning. Here is what’s on President Trump’s agenda today: 1:00 PM THE PRESIDENT signs Executive Orders 4:30 PM THE PRESIDENT arrives Trump National […] Source
Here's what's up with the fall Covid shot *fail*
I feel compelled to address the new Covid shot announcement impacting updated shots for this fall, and the New England Journal of Medicine article published at doctors this week. Many of my patients asked me about vaccines today. And many of them have...
Expert Explains FDA's New COVID Vaccine Rules in The US
On May 20, 2025, the Food and Drug Administration announced a new stance on who should receive the COVID-19 vaccine.The agency said it would approve new versions of the vaccine only for adults 65 years of age and older as well as for people with one or more risk factors for severe COVID-19 outcomes. These risk factors include medical conditions such as asthma, cancer, chronic kidney disease, heart disease and diabetes. However, healthy young…
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