(CNN) — The US has more than 9 million doses of Johnson & Johnson’s coronavirus vaccine ready to be administered now that federal health agencies have signed off on resuming use of the one-shot vaccine, CNN has learned.
President Joe Biden’s coronavirus adviser Jeff Zients told CNN earlier Friday that more than 9 million doses had already been distributed to states, tribes, territories and federal channels and were ready to go once the panel recommended lifting the pause.
On Friday afternoon the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices — a panel that weighed whether to recommend a change in federal guidance on the vaccine — voted to recommend resuming use of the Johnson & Johnson vaccine for individuals 18 years and older. Members of the panel agreed the benefits of the vaccine outweigh the risks from rare blood clots linked with the vaccine.
Later Friday, the CDC and the US Food and Drug Administration lifted their recommended pause on use of the vaccine and said the label will be updated to indicate that women under 50 should be aware of the risk of blood clots. Earlier, Johnson & Johnson officials said they had agreed to updated language for the label.
“I support the ACIP’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,” CDC Director Dr. Rochelle Walensky said Friday.
The FDA will prepare an amended emergency use authorization for the vaccine, Dr. Amanda Cohn, ACIP’s executive secretary, told the panel.
On April 13, the FDA recommended pausing the administering of the one-dose Johnson & Johson coronavirus vaccine after six reported cases of women who developed a rare blood clotting syndrome after receiving the vaccine in the United States.
The CDC has learned of 15 cases of a rare blood clotting condition called thrombocytopenia syndrome (or TTS) linked with Johnson & Johnson’s coronavirus vaccine, an expert told CDC vaccine advisers Friday.
All have been among women, and 13 have been in women under the age of 50, the CDC’s Dr. Tom Shimabukuro told the panel. Three died, and seven remain hospitalized.
So far, patients with TTS linked with Johnson & Johnson’s coronavirus vaccine have started showing symptoms one to two weeks after getting the vaccine, Shimabukuro said.
The risk translates to about seven case of TTS per million doses of J&J vaccine given to women ages 18 to 49, Shimabukuro said, and just under 1 per million for women 50 and older.
“That does not mean there is no risk in males. There could be cases we did not identify in the database,” Shimabukuro said. “There could be cases that become apparent later on that just have not appeared.”
Both the Johnson & Johnson and AstraZeneca Covid-19 vaccines appear to be setting off rare blood clotting events in a few people who get them, but no blood clots have been associated with coronavirus vaccines made by Moderna or Pfizer, experts told the panel.
This story has been updated with additional developments Friday.
The-CNN-Wire
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