CDC, FDA lift pause of J&J vaccine after advisors vote in support of use [Updated]

Update 7:00 pm EDT: The Centers for Disease Control and Prevention and the Food and Drug Administration announced late Friday that the pause on the use of Johnson & Johnson’s one-shot COVID-19 vaccine is now lifted.

The announcement comes just hours after a panel of CDC advisers voted largely in favor of resuming use, reaffirming its recommendation that it be used in all adults.

The two agencies paused use on April 13 after six women developed dangerous blood clots after receiving the vaccine. Though the CDC confirmed nine additional cases during the 11-day pause, the agencies and their advisers determined that the benefits of the vaccine greatly outweigh risks of the extremely rare condition.

“This pause was an example of our extensive safety monitoring working as they were designed to work—identifying even these small number of cases,” Janet Woodcock, acting FDA commissioner, said in an announcement. “We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices… We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider.”

“Our vaccine safety systems are working,” CDC Director Rochelle Walensky added in the announcement. “We identified exceptionally rare events—out of millions of doses of the Janssen COVID-19 administered—and we paused to examine them more carefully. As we always do, we will continue to watch all signals closely as more Americans are vaccinated.”

Original story 6:20 pm EDT: A panel of expert advisers for the Centers for Disease Control and Prevention on Friday voted 10-4 (with one abstention) in favor of lifting the pause on the Johnson & Johnson COVID-19 vaccine. The panel reaffirmed its recommendation for use of the one-shot vaccine in adults of all ages and sexes.

The reaffirmation will come with a new warning in the Food and Drug Administration’s emergency use authorization, which will note that the vaccine appears linked to an extremely rare—but life-threatening—condition that involves serious blood clots and low blood platelets, mainly in women younger than age 50. Experts have dubbed the condition “thrombosis with thrombocytopenia syndrome,” or TTS.

In a day of data presentations, analyses, and discussion, the panel—the Advisory Committee on Immunization Practices (ACIP)—heard all of the risks and benefits of resuming use of the vaccine or restricting its use in certain populations, such as in younger people.

Overall, ACIP firmly determined that the benefits of the vaccine easily exceed the risks, particularly as coronavirus variants continue to spread and medical experts are only beginning to understand the constellation of outcomes and long-term symptoms of COVID-19.

“Community immunity”

“We need as many people to be vaccinated as possible in order to reach community immunity and put the pandemic behind us,” Henry Bernstein, ACIP voting member and professor of pediatrics at Zucker School of Medicine, said in the meeting. “The J&J vaccine will help us do just that.”

Of the 7.98 million doses of Johnson & Johnson’s vaccine administered, there have been 15 confirmed cases of TTS as of April 21. All of the 15 cases were in women between the ages of 18 and 59. However, there was one case of TTS retrospectively identified in a 25-year-old man who participated in an earlier clinical trial.

Of the 15 TTS cases that occurred after authorization, three women died and seven remained hospitalized, with four of those in the intensive care unit (ICU). The remaining five have been discharged.

Breaking down the data further, CDC scientists found that 13 of the 15 TTS cases were in women ages 18 to 49 and that those occurred among 1,866,294 Johnson & Johnson vaccine doses administered to women in that age group. That amounts to a reporting rate of 7 TTS cases per million vaccinated women in that age group. In women ages 50 and above, there were 2 cases of TTS among 2,125,239 doses administered, for a reporting rate of 0.9 per million vaccinated.

Risks and warnings

By contrast, the ACIP heard modeling data today that suggested what would happen if use of the Johnson & Johnson vaccine resumed. Among women ages 18 to 49, the vaccine would prevent 12 COVID-19 deaths and 127 COVID-related ICU admissions per one million women vaccinated in that age group in a six-month period. Among women ages 50 and above, the vaccine would prevent 593 deaths and 1,292 ICU admissions.

Voting members of the ACIP had no doubt that the vaccine’s overall benefits outweigh its risks. Though several members reaffirmed their support for the 11-day pause in use and noted that it allowed them time to review more data and analyses, support for resuming vaccine use at this time was overwhelming.

There were four ACIP members who voted “no” on reaffirming the recommendation for use in all adults. However, they largely did so out of a desire to offer more guidance on the warning of TTS, primarily aimed at women in younger age groups.

“I did not object to the recommendation; I objected to the absence of any kind of guidance from us,” Sarah Long, ACIP voting member and professor of pediatrics at Drexel University College of Medicine, said directly after her “no” vote. “This is an age group that is most at risk [of TTS] that is getting a vaccine predominately to save other people’s lives and morbidity—not their own… I’m very sorry that we haven’t chosen to put up front the knowledge that we have that this is unique, it’s clustered, it’s almost certainly related to the vaccine, and there are options.”

Pablo Sánchez, professor of pediatrics at Ohio State University, echoed the concern. “I have no problem with the continued availability of this vaccine,” he said after his “no” vote. But “I think we have to have stronger language and make sure that people are informed appropriately,” he said.

Avoiding confusion

Pediatrics professor Grace Lee of Stanford offered a counterpoint in support of not having such an additional warning. “I actually agree with all of my colleagues who voted no—I absolutely think that [TTS] is a serious adverse event,” she said. “But I also think that we have to come out with a clear recommendation.” Having a recommendation that both recommended use of the vaccine for all adults but warned that younger women may choose not to use the vaccine “would have been confusing,” she said.

The CDC will now have the final say on the ACIP’s recommendation and, if it agrees, will move forward with resuming vaccinations and providing information to healthcare providers and members of the public on the risks and benefits of the vaccine.