The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.

Moderna is seeking emergency use authorization from the FDA for its Covid-19 vaccine for children 6 months through 5 years of age. 24/7 Live San Francisco East Bay South Bay Peninsula North Bay.

Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.

Fresh off of the heels of a shakeup at the CDC over vaccine recommendations, many Americans still question the necessity and ...

Moderna, Inc. (MRNA) on Thursday announced that the U.S. Food and Drug Administration (FDA) has fully approved its COVID-19 ...

The FDA this week fully approved Moderna’s COVID-19 vaccine for children aged 6 months to 11 years but limited the approval ...

The U.S. Food and Drug Administration approved "Spikevax," Moderna's vaccine for children aged 6 months to 11 years old. The ...

The first COVID-19 vaccine was distributed under an Emergency Use Authorization. More than seven months later, actual approval hasn’t been granted.

To win emergency use authorization, or EUA, drug or device makers may present the FDA with less evidence of a product’s safety and effectiveness than is required for full approval.

Emergency use authorization was also conferred on diagnostic kits to detect emerging infectious diseases such as MERS, H7N9 influenza, Ebola, and Zika. Prior to the COVID-19 pandemic, 33 of these ...

FDA withdraws emergency use authorization of COVID drug because it is unlikely to be effective against new variants. Evusheld doesn't neutralize against several omicron subvariants, the FDA says.

The FDA issued an emergency use authorization to drug-maker Lilly for bamlanivimab, a monoclonal antibody that mimics the immune system’s response to infection with the virus that causes COVID-19.