The U.S. Food and Drug Administration (FDA) is considering adding the strongest safety warning available to COVID-19 vaccines.

The 2024–2025 formulations of COVID-19 vaccines had an effectiveness rate of 76% at preventing emergency or urgent care visits in children aged 9 months through four years, according to a new report.

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans.

The agency highlighted that keeping the product on shelves is in violation of the law and urged the companies to comply with recall protocol. ・Walmart and Target now have 15 working days to respond to the FDA in writing regarding the steps being taken to address any violations.

Last season's COVID-19 vaccine significantly reduced kids' emergency room and urgent care visits, newly released Centers for Disease Control and Prevention data shows. Why it matters: The data released on Thursday comes amid intensifying calls from anti-vaccine groups to pull immunizations off the market.

Former US public health officials are sounding alarms about significant changes being made to the country’s vaccine policy under the Trump administration.

The FDA intends to place a black box label—its most serious warning—on COVID-19 vaccines, according to reporting by CNN. It is unclear if the warning would apply to Moderna’s, Pfizer/BioNTech’s and Novavax’s shots,

The Food and Drug Administration has launched a safety review of two approved RSV drugs for infants, the latest immunizations to face scrutiny under Health Secretary Robert F. Kennedy Jr.

As regulatory uncertainty around COVID vaccines continues to swirl, a new report from the Centers for Disease Control and Prevention (CDC) showcases the benefits of the immunizations among children | The CDC findings were released as the FDA considers placing a black box safety warning on COVID vaccines,