The FDA and Centers for Disease Control lifted their recommended pause of the Johnson & Johnson coronavirus vaccine, with no restrictions on who can receive it, following an extensive safety review. The move immediately opens up access to the almost ten million doses of the one-shot J&J vaccine which had already been distributed the state and local health officials nationwide.
The two agencies had originally recommended the pause on April 13 following reports of extremely rare but serious blood clots in six women who had received the vaccine, as well as to make sure that doctors were aware of the potential side effect and how to safely treat it.
Earlier Friday, the Advisory Committee on Immunization Practices met to review the blood clot cases, and after doing so, the expert panel voted to recommend resuming administration of the J&J vaccine in the U.S. Though the ACIP review identified nine additional cases where people who had received the vaccine developed the blood clots, known as cerebral venous sinus thrombosis, the committee concluded that the benefits of the vaccine, which has already been administered to more than 8 million Americans, vastly outweighed any potential risk posed by the blood clots. Put another way, the panel said the risk from COVID-19 was far greater than the risk of developing the clots.
“We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality,” Acting FDA commissioner Janet Woodcock said Friday. The FDA and Johnson & Johnson are going to update the vaccine label and factsheet to warn of the rare risk of the blood clot and note its symptoms — including severe headache, shortness of breath, abdominal pain, or leg swelling within three weeks of receiving the vaccine — so that anyone experiencing them can seek immediate medical attention.
