New FDA restrictions will make COVID-19 vaccines only available to elderly and people with medical conditions
- On Thursday, government experts will convene to determine whether COVID-19 vaccines require modifications to enhance protection during the upcoming fall and winter seasons.
- The meeting follows recent FDA policy changes limiting routine booster approval to seniors and high-risk younger people, unlike the prior universal recommendation.
- The policy shift has caused uncertainty about vaccine eligibility for healthy individuals, insurance coverage, and implications for unvaccinated babies as fall approaches.
- Dr. Vinay Prasad, who leads the FDA’s vaccine efforts, stated that the agency is seeking input on which COVID-19 strains to include in future vaccines, aims to allow more time for people to understand the new vaccination policy, and remains receptive to receiving feedback.
- This change challenges the upcoming vaccination campaign, reflecting criticism of the U.S.'s "one-size-fits-all" approach long out of step with Europe’s more limited booster recommendations.
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437 Articles
The EXPLOSION of myocarditis: Dr. Peter McCullough’s bombshell vaccine testimony
In a Senate hearing this week about the safety of the COVID-19 vaccine, Dr. Peter McCullough detailed his experience as a cardiologist — and after the shots, it’s not a good one. “The topic today is myocarditis or heart damage from the COVID-19 vaccines. I’m a cardiologist. I know the topic well...
FDA Orders COVID-19 Vaccine Makers to Expand Heart Inflammation Warning - News Addicts
The Food and Drug Administration has directed COVID-19 vaccine manufacturers to expand the warning for two forms of inflammation, according to letters made public on May 21. The FDA told BioNTech, which produces a vaccine with Pfizer, and Moderna to update warnings regarding myocarditis—or heart inflammation—and the related condition pericarditis. Richard Forshee, acting director of […] The post FDA Orders COVID-19 Vaccine Makers to Expand Heart…
FDA Panel Split on COVID-19 Booster Update Amid Policy Confusion
Government advisers were split Thursday on whether drugmakers need to update their COVID-19 vaccines for next season, a decision overshadowed by confusion over a new Trump administration policy that may limit which Americans can get the shots. The Food and Drug Administration’s outside experts have met annually since the launch of the first COVID-19 vaccines to discuss tweaking their recipes to stay ahead of the virus. The challenge is trying to…
San Diego doctors react to new FDA guidelines on COVID-19 shots
SAN DIEGO (FOX 5/KUSI) — The U.S. Food and Drug Administration is implementing more rigorous standards for approving future COVD-19 vaccines. The agency is no longer recommending universal boosters for everyone 6 months or older and will now take a more targeted approach, limiting its availability to seniors and those with pre-existing conditions that put them at a high-risk for severe illness. These new guidelines were published Tuesday in the …
FDA Advisers Recommend Updated COVID-19 Vaccines
Advisers to the Food and Drug Administration on May 22 recommended the agency direct COVID-19 vaccine manufacturers to update the strain their shots target. The Vaccines and Related Biological Products Advisory Committee unanimously voted to advise the regulator to have vaccines updated to target a single strain, one of the JN.1 subvariants. The Moderna and Pfizer vaccines currently contain formulations for the KP.2 strain, while Novavax’s vacci…
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