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Moderna Files FDA Application for the LP.8.1 Targeting COVID-19 Vaccine
CAMBRIDGE, MA / ACCESS Newswire / May 23, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2025-2026 formula,
With vaccine approval process set to change, FDA advisers leave wiggle room in annual Covid-19 shot recommendations
A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make a broad recommendation about which lineage of the coronavirus should be included in this year’s Covid-19 vaccines,
FDA to limit COVID-19 boosters for 'low risk' people under 65. What to know in Tennessee
Healthy and under the age of 65? You might not need to receive an annual COVID-19 booster. What to know about new guidelines.
FDA Plans to Limit COVID-19 Vaccines to High-Risk Groups
In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the Center for Biologics Evaluation and research at the FDA, and Dr. Martin Makary, FDA commissioner, explained their plan for how the FDA will evaluate and recommend COVID-19 vaccines going forward.
FDA Updates COVID-19 Vaccine Regulations—Here’s What to Know
The FDA has updated COVID-19 vaccine regulations. Only people aged 65 and up, along with certain groups, will be eligible to receive booster shots. FDA officials are asking for more data around the vaccine’s effectiveness for people who are otherwise healthy.
Trump FDA overhauls COVID-19 vaccine approval to focus on older populations, high-risk individuals
The FDA announced a policy shift for COVID-19 vaccine approvals to focus on Americans considered high-risk of contracting the virus, and those older than age 65.
FDA limits access to COVID-19 vaccine to older adults and other high-risk groups – a public health expert explains the new rules
The FDA’s new framework for COVID-19 vaccines breaks from established procedure for how the government establishes vaccine guidelines.
After delay, FDA approves Novavax’s Covid-19 vaccine, but only for older people and those at high risk
After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter from the agency, but only for people 65 and older and those 12 and up who have at least one underlying condition that puts them at higher risk of severe illness.
New FDA chiefs limit Covid-19 shots to elderly, sick
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FDA asks mRNA vaccine makers to widen age range for rare heart risk warning
In another sign of growing scrutiny over Covid-19 vaccines, the Food and Drug Administration has asked the two makers of mRNA vaccines to widen the age range of boys and young men that their labels say are at risk for a rare side effect causing heart inflammation.
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