Health officials with the Centers for Disease Control and Prevention and Food and Drug Administration have announced an end to the pause on the Johnson & Johnson COVID-19 vaccine.
The government announced Friday evening that the CDC and FDA are lifting the 11-day pause after reviewing the data, saying the one-and-done vaccine is safe and effective.
The CDC and FDA decided that J&J's vaccine is critical to fight the pandemic — and that the small clot risk could be handled with warnings to help younger women decide if they should use that shot or an alternative.
Asked about that particular demographic, CDC Director Dr. Rochelle Walensky said it is one of three vaccines that would be safely available for women under age 50 to use.
"We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality," acting FDA Commissioner Dr. Janet Woodcock said in a statement. "We recommend people with questions about which vaccine is right for them have those discussions with their health care provider."
Scientific advisers decided its benefits outweigh a rare risk of blood clot.
"I support the [committee's] recommendation that the Johnson and Johnson COVID-19 vaccine be used for persons 18 years of age or older in the United States population under the FDA emergency use authorization, and I have signed this recommendation," Walensky said Friday.
A government advisory panel deliberated Friday on the issue after the CDC and FDA recommended a pause of the one-dose vaccine on April 13.
The committee's recommendation, approved 10-4, was that the J&J vaccine is recommended for persons 18 and older in the U.S. under the FDA’s emergency use authorization.
Health officials said Friday they were aware of 15 cases of the unusual clots since the government authorized use of the vaccine and nearly 8 million shots were given. All were women, most of them under 50. Three died, and seven remain hospitalized.
The Food and Drug Administration updated online vaccine information leaflets for would-be recipients and health workers, so that shots could resume.
European regulators earlier this week allowed the rollout of J&J's shot after concluding those benefits outweigh what appears to be an exceedingly rare risk.
At issue is a weird kind of blood clot that forms in unusual places, such as veins that drain blood from the brain, and in patients with abnormally low levels of the platelets that form clots. The CDC and Food and Drug Administration initially spotted six people who developed such clots one to three weeks after J&J vaccination. On Friday, health officials said nine more cases came to light in the last week or so.
File video: Doctor discusses next steps with Johnson & Johnson COVID-19 vaccine prior to advisory committee decision
The needle-in-a-haystack reports raised alarm because European regulators already had uncovered similar rare clots among recipients of another COVID-19 vaccine, from AstraZeneca. The AstraZeneca and J&J shots, while not identical, are made with the same technology.
European scientists found clues that an abnormal platelet-harming immune response to AstraZeneca’s vaccine might be to blame — and if so, then doctors should avoid the most common clot treatment, a blood thinner called heparin.
That added to U.S. authorities’ urgency in pausing J&J vaccinations so they could tell doctors how to diagnose and treat these rare clots. Six patients were treated with heparin before anyone realized that might harm instead of help.
Two-dose vaccines from Pfizer and Moderna, which are made differently and haven't been linked to clot risks, are the mainstay of the U.S. vaccination effort. In the U.S., more than half of adults have received at least one vaccine dose, the vast majority with the Pfizer and Moderna shots.
But J&J mass vaccination clinics were canceled after the April 13 pause, and many states had been counting on the one-and-done option to also help protect hard-to-reach populations including people who are homeless or disabled.
J&J faces an additional hurdle, as the FDA separately uncovered manufacturing violations at a Baltimore factory the company had hired to help brew the vaccine. No shots made by Emergent BioSciences have been used — J&J's production so far has come from Europe. But it's unclear how the idled factory will impact J&J's pledge to provide 100 million U.S. vaccine doses by the end of May and 1 billion doses globally this year.
COVID-19 itself can cause blood clots. So can everyday medications, such as birth control pills.
The Associated Press contributed to this report.