The U.S. Food and Drug Administration on Tuesday said it plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65, effectively limiting them to older adults and those at risk of developing severe illness.

Previously, the FDA recommended COVID-19 vaccines for everyone aged 6 months and older. Under the new plan, shots for healthy kids and adults will need to go through placebo-controlled clinical trials before they can get approved.

The FDA has updated COVID-19 vaccine regulations. Only people aged 65 and up, along with certain groups, will be eligible to receive booster shots. FDA officials are asking for more data around the vaccine’s effectiveness for people who are otherwise healthy.

The FDA laid out new requirements for access to yearly COVID shots, saying they'd continue to offer them to adults 65 and older, as well as children and younger adults with at least one health problem that puts them at higher risk.

Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.

Kennedy Jr. -- are restricting access to COVID shots that were a signature accomplishment of President Trump's first term and cost taxpayers about $13 billion to develop, produce, and distribute. The agencies are narrowing vaccination recommendations,

The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory processes.

New FDA framework on changes coronavirus vaccine approval will be released “in the coming days,” FDA Commissioner Marty Makary said Thursday.

Under a new policy announced Tuesday by the Trump administration, only people age 65 and older and children or young adults with certain health conditions that puts them at risk will be approved for the shot.

The Food and Drug Administration is taking a new approach to COVID-19 vaccines that would prioritize ... But critics say the new requirements bypass the usual input from independent outside ...