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

Thomas Barrabi
·2 min read

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

The Food and Drug Administration and the Centers Disease Control and Prevention lifted the pause shortly after a CDC advisory panel recommended a resumption of its use. The panel recommended inclusion of language warning the public of a risk of blood clots upon receiving the single-dose vaccine.

"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.

"At this time, the available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk," the agencies said in a press release.

European regulators reached a similar decision earlier this week and allowed the rollout of the Johnson & Johnson vaccine to resume.

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Johnson & Johnson said it was "grateful to the Advisory Committee and its medical experts for the rigorous evaluation of our COVID-19 vaccine."

"The Committee’s recommendation is an essential step toward continuing urgently needed vaccinations in a safe way for millions of people in the U.S," the company said in a statement. "As the global pandemic continues to devastate communities around the world, we believe a single-shot, easily transportable COVID-19 vaccine with demonstrated protection against multiple variants can help protect the health and safety of people everywhere."