The FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna ...

The FDA is defending a decision to restrict access to a newly-approved low dose COVID vaccine from Moderna that the company ...

The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement ...

The shot, dubbed mNexspike, is approved for older adults and people whose health conditions put them at higher risk of severe ...

The CDC will no longer recommend the COVID-19 vaccine for pregnant women and healthy children. Updated COVID-19 shots will ...

"Political directives should not prevent individuals from seeking safe and effective care that they desire and deserve," ...

The FDA is implementing stricter guidance for the approval of COVID-19 vaccines, according to a paper published in The New England Journal of Medicine.

The FDA's shift in strategy could make it much harder for people who are younger than 65 and don’t have “risk factors for ...

There is no “the” vaccine. There are at least two mRNA vaccines (Moderna and Pfizer) and a number of different non-mRNA ...

The FDA expects that randomized, controlled trial data on clinical outcomes will be needed before COVID-19 vaccines can be approved for patients who are 6 months to 64 years of age and do not have ...

After the FDA announced that it would no longer authorize new COVID-19 vaccines for healthy Americans under age 65, the CDC ...

The FDA will encourage new clinical trials on the widely used vaccines before approving them for children and healthy adults.