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Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida.
Enlarge / Boxes of Johnson & Johnson’s Janssen COVID-19 vaccine at a vaccination site in Florida.

A panel of expert advisors for the Centers for Disease Control and Prevention on Friday voted 10 to four (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 exceeded 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.

“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

In 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 outweighed the 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.

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, move forward with resuming vaccinations and providing information to healthcare providers and members of the public on the risks and benefits of the vaccine.

Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida.
Enlarge / Boxes of Johnson & Johnson’s Janssen COVID-19 vaccine at a vaccination site in Florida.

An advisory committee for the Centers for Disease Control and Prevention declined to vote on the fate of Johnson & Johnson’s COVID-19 vaccine Wednesday, likely leaving in place a pause on the vaccine’s use until the committee reconvenes in seven to 10 days.

The CDC’s Advisory Committee on Immunization Practices, or ACIP, expects that the coming week or so will provide additional data and analyses on the vaccine’s potential risks. Until it has more information, ACIP opted to provide no new recommendations on the use of the vaccine.

On the table, however, was everything from recommending against use of the vaccine altogether; recommending that only certain groups receive the vaccine, such as only men or only people over a certain age; or recommending that the pause be lifted and use continue in all adults as before.

In a hearty discussion Wednesday afternoon, ACIP members said they simply didn’t feel they had enough information on updated vaccine risks to vote one way or the other on any of the possible usage recommendations.

Emergency pause

ACIP gathered for the emergency meeting Wednesday after the CDC and the Food and Drug Administration abruptly announced on Tuesday that they were pausing use of the Johnson & Johnson vaccine. The agencies linked the vaccine to six illnesses involving an unusual combination of dangerous blood clots and low platelet levels. One person died from their condition and another is in critical condition.

The cases are extremely rare, with the six occurring among more than 6.8 million people vaccinated with the Johnson & Johnson vaccine. However, the cases closely resemble a very rare side effect seen in some people who have received AstraZeneca’s COVID-19 vaccine, which uses a similar adenovirus-based vaccine design.

With both vaccines, authorities noted unusual cases of cerebral venous sinus thrombosis (CVST), coupled with low blood levels of blood platelets (thrombocytopenia). CVST is a rare type of stroke in which a clot prevents blood from draining out of the brain. Platelets are the cell fragments in blood that stick together to form clots. Typically, low levels of platelets lead to bleeding, not clotting conditions, like CVST. In fact, it’s such an unusual combination that it’s unclear how often CVST even occurs in combination with thrombocytopenia in the absence of the vaccines. As such, researchers and public health experts have struggled to estimate the potential increased risk of developing this combination after taking either of the vaccines.

However, there’s a clear pattern emerging in these extremely rare, vaccine-linked cases—and researchers speculate that the vaccines may be triggering an aberrant immune response. A similar condition is seen rarely in patients given the blood thinner heparin. For reasons researchers don’t entirely understand, a small number of patients given heparin produce antibodies that attack a common platelet protein called Platelet Factor 4, or PF4. These antibodies activate platelets, leading to a hyperclotting state, while also promoting platelet clearance, dragging down platelet levels.

Case details

So far, many of the people who developed blood clots and thrombocytopenia after receiving the AstraZeneca vaccine also tested positive for antibodies against PF4, even though they were not given heparin. In the ACIP meeting today, CDC researchers noted that five of the six people with clotting cases linked to the Johnson & Johnson vaccine also tested positive for antibodies against PF4. The sixth case wasn’t tested.

There were other intriguing details revealed in the meeting as well. All six of the cases reviewed by the CDC and FDA were in white women between the ages of 18 and 48. This has led some people to speculate that for these women in the child-bearing age range, the blood clots could be related to the use of birth control pills, which carry their own risk for clotting. However, according to the data discussed in the ACIP meeting, only one of the six affected women was taking birth control pills.

Moreover, an analysis by scientists at Johnson & Johnson found a seventh case of CVST with thrombocytopenia in one of their clinical trial participants—a male participant. The previously healthy 25-year-old man developed CVST, low blood platelets, and tested positive for anti-PF4 antibodies after taking the vaccine.

To date, CDC researchers and other scientists have found no obvious pattern of risk factors for developing the life-threatening blood clots and low platelet levels.

Outlook

But, CDC researchers and ACIP members expect they may see more cases emerge in the coming days. As noted in today’s meeting, the combination of CVST and thrombocytopenia tends to occur six to 13 days after vaccination. However, a little more than half of all doses of Johnson & Johnson vaccine that have been administered in the US to date were administered in the past two weeks. Specifically, prior to March 30, there were 3.47 million Johnson & Johnson doses administered in the US, or 48 percent of all doses administered to date. Between March 30 and April 13, there were 3.77 million doses administered, or 52 percent of all doses administered. That suggests that, despite the pause in vaccine use, there may be more cases detected in the coming weeks, particularly with lags in clinical reporting.

With the sparse data analysis so far and the potential for more cases and data to arise shortly, the ACIP opted to hold out a little longer before making any recommendations. Their position is a difficult one. They’re trying to balance safety concerns with the urge to vaccinate people as quickly as possible against the deadly pandemic coronavirus, particularly as virus variants emerge and spread. They were also sensitive to the reality that the adenovirus-based vaccines (made by Johnson & Johnson, AstraZeneca, and others) are more likely to be used in vulnerable populations and developing countries. The pauses and drama around these vaccines in places like the US and EU could increase vaccine hesitancy in populations with few other vaccine options.

For the US population overall, however, CDC researchers noted in the meeting today that the country’s vaccine supply is still strong. Even with the extended Johnson & Johnson pause, the US has steady supplies of mRNA vaccines from Moderna and Pfizer-BioNTech.