FDA, COVID-19 and vaccine
Digest more
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,
The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels about heart inflammation.
New guidelines for COVID vaccine. Prior to the new guidelines, it was recommended that everyone who is 6 months and older get at least one vaccine per year, with those in higher-0
2don MSN
The vaccine eligibility change is a threat to the health of Americans, some experts say, adding that the FDA is not being forthcoming about its research.
The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.
Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.
With new testing requirements, it’s not even clear whether new Covid or flu shots can be made available this fall.
The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.