US EditionNew 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.
437 Articles
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…
The FDA has called on vaccine manufacturers Pfizer and Moderna to provide their Covid-19 gene syringes with much sharper warnings of possible heart damage. An analysis of the data from market surveillance shows that the risks to myocarditis and pericarditis are greater than originally assumed. The new findings again raise questions about the transparency and communication of the health authorities during the pandemic. The letters to both compani…
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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