An updated warning will be added to the label.
The CDC and US Food and Drug Administration recommended pausing the use of the vaccine on April 13 while they investigated the risk of rare, severe blood clots. On Friday, members of the CDC’s Advisory Committee for Immunization Practices agreed the benefits of the vaccine outweigh the risks from rare blood clots linked with the vaccine.
Committee members worried that taking one of only three vaccines out of the mix available to Americans would slow efforts to immunize the population against a virus that has killed more than half a million people in the United States. Plus, they agreed that having a one-shot vaccine that doesn’t need to be stored in freezers was valuable and would be preferred by many people who do not want to come back for a second dose, or who would struggle to make two vaccination appointments.
The language of the vote: “The Janssen Covid-19 vaccine is recommended for persons 18 years of age and older in the U.S. population under the FDA’s emergency use authorization.”
The vote was 10 in favor, four opposed, with one abstention.
The US Food and Drug Administration will update the label for the vaccine, indicating that women under the age of 50 should be aware of the risk of a rare blood clotting syndrome associated with the vaccine.
Earlier, Johnson & Johnson officials said they had agreed to new language for the label that acknowledges the risk of thrombosis with thrombocytopenia syndrome, or TTS.
The CDC now has reports of 15 cases, all in women, and 13 of them in women under the age of 50. Three have died.
CDC Director Dr. Rochelle Walensky will sign off on ACIP’s recommendation and then FDA will prepare an amended emergency use authorization for the vaccine, Dr. Amanda Cohn, ACIP’s executive secretary, told the meeting.
“We are awaiting and anticipate that the FDA will be putting out a new, a newly approved EUA language,” Cohn said.
“And additionally, we will be taking the input from today, along with this language that FDA will publish and both FDA and CDC will have communication materials and education materials including infographics, patient fact sheets.”
Next week the CDC has scheduled a telephone briefing for doctors and other clinicians to explain the changed recommendations and lay out the symptoms and treatments for TTS.
There will also be a Morbidity and Mortality Weekly Report — the CDC’s main publication for disseminating health news — to share the information.
Risks and benefits
The CDC’s Dr. Sara Oliver presented the results of several models laying out what might happen if the vaccine is used again, including with restrictions on use in certain groups. The CDC took into consideration deaths from coronavirus and the likelihood that people would get vaccinated more quickly if the Janssen vaccine was in the mix.
“When resuming vaccination among all persons at least 18 years, we expect 26 to 45 TTS cases depending on vaccine uptake,” she said. But 600 to 1,400 deaths from Covid-19 would be prevented, and as many as 3,500 ICU admissions would be prevented.
If the vaccine were restricted to people over the age of 50, three TTS cases could be expected, but between 40 and 250 Covid-19 deaths would be prevented, and as many as 1,000 people would not need treatment in the ICU.
For every million doses of vaccine given to women 18 to 49, 13 TTS cases can be expected, Oliver said. But 12 deaths from Covid-19 would be prevented and 127 ICU admissions would be prevented among those women if they had access to the Janssen vaccine.
The CDC did not consider a gender-based restriction, Oliver said, because it would be too hard to explain — even though the risk of blood clots appears to be very low among men.