FDA Commissioner Marty Makary announced Thursday that the agency will soon provide clear guidelines to vaccine manufacturers for annually updating their Covid-19 shots.

The FDA announced it will limit access to Covid-19 vaccines going forward to people 65 and older and others at high risk of serious illness

"Expert Panels with the FDA" are a series of roundtable discussions to provide an open public discourse on the latest medical and scientific information on several important topics. At this roundtable,

FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad set stricter approval standards for booster shots

The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new commissioner described as a “one-size-fits-all regulatory framework.”

The FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for certain approvals. | FDA Commissioner Marty Makary, M.D., and CBER head Vinay Prasad, M.D.

While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner Marty Makary’s proposal is light on details and raises potential concerns about safety,

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans — a move that will limit future vaccines to older Americans and people at higher risk of serious Covid-19 infection.

The U.S. Food and Drug Administration plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65, effectively limiting their availability later this year to older adults and those at risk of developing severe illness,

The restrictions on Novavax's vaccine could portend changes at the FDA. Commissioner Marty Makary suggested last week that the agency could update its vaccine approval guidelines “in the coming days.”