FDA lifts Johnson & Johnson COVID-19 vaccine pause following safety review

Federal health officials lifted a pause on use of the Johnson & Johnson COVID-19 vaccine on Friday following an 11-day review and the recommendation of a panel of experts who determined it met safety standards despite rare instances of severe blood clots.

"We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older," Acting FDA Commissioner Janet Woodcock said in a statement. "We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality." Health officials paused the rollout of the Johnson & Johnson vaccine on April 13 in response to six reported cases of thrombosis with thrombocytopenia syndrome (TTS). At the time, the FDA said it had recommended a pause and subsequent safety review out of an abundance of caution. The FDA and CDC said they have identified a total of 15 cases among nearly eight million recipients, all of which occurred in women between ages 18 and 59. Three of the women died and seven remain hospitalized. Officials said symptoms associated with the blood clots appeared between six and 15 days after vaccination.