U.S. health officials lifted the pause on Johnson and Johnson's COVID vaccine Friday and will be adding a warning label from now on.
It was on hold for 11 days amid concerns about rare but serious blood clots.
The CDC and FDA agreed with an advisory panel's recommendation to resume giving the vaccine, saying its benefits outweigh the rare risks.
Acting FDA commissioner Janet Woodcock said: "Now, this is not a decision the agencies reached lightly. Medical and scientific teams of both the FDA and CDC reviewed several sources of information and data related to the Janssen COVID-19 vaccine to reach today's assessment."
Fifteen women, most of them between 18 and 48 years old, developed the blot clots after getting it, and three died.
Nearly 8 million people have gotten the J&J vaccine.