Federal officials have re-authorized the Johnson & Johnson covid-19 vaccine in the United States, but with an updated label to warn of the risks of blood clots.
Food and Drug Administration and Centers for Disease Control and Prevention called for a pause on vaccine use April 13 in response to a small number of reports potentially linking the single dose vaccine to severe blood clotting. Of the nearly 8 million Americans who have received the vaccine so far, agencies said they have confirmed 15 cases of people developing thrombosis-thrombocytopenia syndrome (TTS), characterized by low levels of blood platelets and a rare and serious type of blood clot that forms in the brain. All of these cases involved women aged 18 to 59. Symptoms started to develop six to 15 days after receiving the vaccine.
The FDA and CDC have lifted their a recommended break on Fridays after a thorough investigation, consultations with providers and clinicians, and a positive recommendation of the CDC Advisory Committee for Immunization Practices. In a joint declarationFDA Acting Commissioner Janet Woodcock said health regulators have concluded that the benefits of the J&J vaccine “outweigh its known and potential risks.”
“We are confident that this vaccine continues to meet our standards for safety, efficacy and quality,” she said. “We recommend that people who have questions about the right vaccine for them have these discussions with their health care provider.”
Available data suggests that the risk of vaccinees developing TTS is very low, according to agency findings. Nonetheless, they will continue to investigate the risk and monitor cases as the J&J vaccine begins to roll out again. Federal advice About the vaccine for healthcare providers, recipients and caregivers has also been updated to include information about the risk of blood clotting.
“Above all, health and safety are at the forefront of our decisions,” CDC director Rochelle Walensky said in Friday’s statement. “Our vaccine safety systems are working. We have identified exceptionally rare events – over millions of doses of [J&J vaccine] administered – and we stopped to examine them more carefully. As we always do, we will continue to monitor all signals closely as more Americans are vaccinated. “