COVID-19, FDA and vaccine
Digest more
Top News
Overview
Impacts
The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart condition after vaccination.
Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot,
Since 2023, federal health officials have recommended an annual COVID-19 shot for most people, and vaccine makers have not needed to conduct additional tests on each year’s updated vaccine. It's similar to the way the annual flu shot is updated to target the newest influenza strains,
Help Register Login Login Hi, %{firstName}% Hi, %{firstName}% Games Car rental The U.S. Food and Drug Administration (FDA) has officially approved a COVID-19 vaccine from Novavax for adults 65 and older and for individuals ages 12 to 64 who have an underlying health condition that puts them at higher risk for serious illness from a coronavirus infection.
The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.
The Trump administration shared the outlines of how it plans to push drug companies to lower their prices in the U.S.
The announcement, which followed the FDA setting new guidelines on COVID vaccine approvals, erased the stock’s gains from yesterday.
Moderna filed for FDA approval of its mRNA-1083 combination shot last year. The submission put the biotech on track to win approval in adults aged 50 and older in November 2025. However, at the start of May, Moderna pushed back the expected approval date to 2026 after the FDA asked to see phase 3 efficacy before making a decision on authorization.