This story was updated at 7:55 p.m.
April 23, 2021 — Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the FDA and CDC said Friday, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.
“We have concluded that the known and potential benefits of the [Johnson & Johnson] COVID-19 vaccine outweigh its known and potential risks in individuals 18 years of age and older,” acting FDA commissioner Janet Woodcock, MD, said in a statement.
The recommendation to continue the vaccine’s rollout came barely 2 hours after a CDC Advisory Committee on Immunization Practices voted to recommend the pause be lifted. The vote was 10-4 with one abstention.
The decision also includes instructions for the warning directed at women under 50 who have an increased risk of a rare but serious blood clot disorder called thrombosis with thrombocytopenia syndrome (TTS).
As of April 21, 15 cases of TTS, all in women and 13 of them in women under 50, have been confirmed among 7.98 million doses of the J&J vaccine administered in the U.S. Three women have died.
The FDA and CDC recommended the pause on April 13 after reports that 6 women developed a blood clotting disorder 6 to 13 days after they received the J&J vaccine.
William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville, and a non-voting ACIP member, said in an interview the panel made the right recommendation.
He applauded both the decision to restart the vaccine and the updated warning information that “will explain [TTS] more fully to people, particularly women, who are coming to be vaccinated.”
As to women in the risk group needing to have a choice of vaccines, Schaffner said that will be addressed differently across the country.
“Every provider will not have alternative vaccines in their location so there will be many different ways to do this. You may have to get this information and select which site you’re going to depending on which vaccine is available if this matter is important to you,” he noted.
ACIP made today’s decision after a 6-hour emergency meeting to hear evidence on benefit of Johnson & Johnson’s protective benefits against COVID-19 vs. risk of TTS.
Tom Shimabukuro, MD, with the CDC, explained TTS is a rare but serious and potentially fatal side effect.
The clotting appears to occur 1 to 2 weeks after vaccination. These clots appear similar to what is being seen after the AstraZeneca COVID-19 vaccine in Europe.
The U.S. patients who have developed these blood clots are an average of 37 years old. Twelve of the cases were cerebral venous sinus thrombosis (CVST) cases.
He noted that though headache is a common symptom after COVID-19 vaccines, the headaches with TTS typically appear after 6 days rather than a day after the injection.
Shimabukuro said 7.98 million Johnson & Johnson vaccine doses have been administered as of April 21 and 15 cases of TTS have been confirmed, all in women. Three of the women have died.
This story will be updated.