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American Hospital Association1h
FDA to limit COVID-19 vaccine to people over 65, others at high risk for serious illness
Leaders of the Food and Drug Administration May 20 announced new guidelines for administering the COVID-19 vaccine in a paper ...
Health News Florida1h
A stricter FDA policy for COVID vaccines could limit future access
Federal officials unveiled a rigorous regulatory approach to future COVID vaccines that could make it harder for many people ...
BioSpace1h
FDA’s New Risk-Based Approach to COVID-19 Vaccines Aims to Ease ‘Public Distrust’: Makary, Prasad
The new framework was well-received by biopharma analysts, who say it “largely formalizes” current COVID-19 vaccination ...
FDA to require clinical trials for COVID boosters for healthy adults and children
FDA Commissioner Marty Makary and Dr. Vinay Prasad outlined their booster shot clinical trial requirements in the New England Journal of Medicine.
FDA Changes May Limit COVID Vaccine Access—Drawing Some Criticism. Here’s What We Know
The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new ...
F.D.A. Poised to Restrict Access to Covid Vaccines
Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many ...
You asked: Are vaccines approved without safety studies?
No, this is not true. Vaccines undergo rigorous safety testing and are continuously monitored for adverse events.
STAT3h
FDA will limit Covid vaccines to people over 65 or at high risk of serious illness, leaders say
The FDA announced it will limit access to Covid-19 vaccines going forward to people 65 and older and others at high risk of ...
BioPharma Dive4h
FDA sets stricter approval standards for COVID vaccines
The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, ...
Who can get updated COVID vaccines this fall? FDA will OK for high-risk groups, calls for new clinical trials
"The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at ...
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 ...
COVID vaccine rollout for healthy kids and adults is likely delayed by a new FDA rule
The requirement for placebo-controlled trials isn’t expected to affect the rollout this fall for older adults and other groups at high risk for severe illness.