FDA sets new requirements for COVID vaccines in healthy …
May 20, 2025 · Top officials for the Food and Drug Administration laid out new requirements for access to yearly COVID shots, saying they'd continue to use a streamlined approach that would continue offering them to adults 65 and older as well as children and younger adults with at least one health problem that puts them at higher risk.
FDA sets stricter approval standards for COVID vaccines
May 20, 2025 · The Food and Drug Administration is changing how it reviews new COVID-19 vaccines, setting out stricter standards in place of the framework it used to quickly clear updated boosters for all adults the past few years. The new guidelines were revealed Tuesday in a paper published in The New England ...
Who is eligible for a COVID shot? What to know about the latest …
May 21, 2025 · Days before the FDA’s COVID recommendations were released, Makary announced he was planning to “unleash a massive framework” on the FDA’s expectations for vaccine makers. The new change to ...
FDA tightens requirements for COVID vaccine, adding trials for …
May 20, 2025 · The U.S. Food and Drug Administration on Tuesday said it plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65, effectively limiting...
FDA outlines stricter Covid vaccine approval standards
May 20, 2025 · The FDA recommended different standards of evidence for approval based on patients' risk of getting severely sick from Covid.
FDA sets new rules for COVID vaccines in healthy adults and …
May 20, 2025 · Top officials for the Food and Drug Administration laid out new requirements for yearly updates to COVID shots, saying they’d continue to use a streamlined approach that would make vaccines...
FDA vaccine framework changes Covid shot recommendations
May 20, 2025 · FDA will limit Covid vaccines to people over 65 or at high risk of serious illness, leaders say In shift away from universal access, new studies of Covid boosters will be required for people under ...
What to know about the FDA's latest COVID-19 vaccine changes
May 22, 2025 · COVID-19 vaccine recommendations could be changing, according to the U.S. Food and Drug Administration. FDA leaders said on May 20 that clinical trials will be required to approve annual...
An Evidence-Based Approach to Covid-19 Vaccination | New …
May 20, 2025 · Moving forward, the FDA will adopt the following Covid-19 vaccination regulatory framework: On the basis of immunogenicity — proof that a vaccine can generate antibody titers in people — the ...
FDA will approve COVID-19 vaccine only for older adults and …
May 21, 2025 · The new, narrower FDA approval will likely reduce both access to COVID-19 vaccines for the general public and insurance coverage for COVID-19 vaccines. The FDA’s focus on individual risks and ...