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

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people ...

The FDA is reportedly considering the addition of high-level warning labels to COVID vaccines, a move that some experts say ...

Pfizer's COVID-19 vaccine has become the first in the U.S. to receive full approval from the FDA for people ages 16 and up.

The Food and Drug Administration (FDA) is investigating whether the COVID-19 vaccines were associated with any deaths across ...

The FDA plans to add a “black-box warning” to COVID-19 vaccines — that’s the strongest warning the agency can issue. But Will ...

The FDA intends to place a black box label—its most serious warning—on COVID-19 vaccines, according to reporting by CNN. It ...

U.S. Food and Drug Administration officials said COVID-19 vaccines killed at least 10 children, providing no evidence for the ...

Food and Drug Administration officials say they will ratchet up requirements for vaccine studies, citing concerns about COVID shots for kids. But public health experts question the agency's analysis.

FDA weighs black box warning for COVID-19 vaccines, signaling a major shift in safety labeling and regulatory approach for these shots.

The U.S. health regulator is investigating deaths potentially related to COVID-19 vaccines across multiple age groups as part ...