Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based ...

The Novavax vaccine targets the same XBB.1.5 variant as the other two vaccines. That variant was the dominant one in the U.S. earlier this year when the FDA had to choose the makeup of this fall's ...

The US Food and Drug Administration on Wednesday authorized Novavax’s Covid-19 vaccine for emergency use in adults. It is the fourth coronavirus vaccine available in the United States, and it ...

The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally ...

Most of the FDA’s Vaccines and Related Biological Products Advisory Committee voted “yes” in response to a question of whether the benefits of Novavax’s vaccine, given as a two-dose ...

Novavax officials said they don't think the rate of myocarditis is any higher among trial participants than the general population, but FDA officials said it remains a question.

If greenlighted by the FDA, Novavax's shots could be the first COVID-19 doses available in the U.S. based on a kind of "protein subunit" technology that has been used for decades in other routine ...

The Food and Drug Administration's independent panel of advisers has voted in favor of the FDA authorizing Novavax, a protein-based vaccine, which could soon be the fourth vaccine for COVID-19 ...

Novavax will only be able to offer a COVID-19 vaccine in the United States this autumn if regulators accept the shot it has ... Novavax awaits FDA decision on whether its next COVID shot can be ...

For Novavax, it is three weeks after the last dose and for the two others it is at least two months. On June 5 , an FDA advisory panel recommended updating the formula for COVID-19 vaccines.

Gaithersburg-based Novavax, Inc. announced its updated vaccine has received emergency use authorization from the FDA. (File photo) Associated Press // May 1, 2025 // ...

Even with FDA authorization, Novavax may be too late. While its vaccine is licensed in 41 countries and at least 42 million doses have been distributed, the world is overstocked with COVID-19 vaccine.