The FDA and CDC are recommending a pause on the Johnson
& Johnson COVID vaccine after six women developed rare blood clots.
Certain hard-to-reach populations in Arizona are missing out on getting protection from COVID-19 during a pause on the Johnson & Johnson COVID-19 vaccine.
Johnson & Johnson’s Janssen vaccine has been administered at a farlower rate than either the Moderna or Pfizer vaccines in Arizona. But it still is an important vaccine for some groups of people, including people with transportation and housing issues, and people with inflexible job obligations.
The Janssen vaccine has several advantages that the other two vaccines do not: It requires only refrigeration and not a deep freezer for storage; it’s a single dose instead of two; it requires fewer medical staff and other resources for clinics administering the vaccine; and because it’s just one dose, those who receive the vaccine are considered fully vaccinated after two weeks rather than five or six.
In Arizona, the vaccine has been popular at community health clinics and at targeted events in underserved communities or for essential workers. Some people have sought out the vaccine because of the convenience of only having to get one shot.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices held an emergency meeting Wednesday after reports that six women developed severe and rare blood clots within two weeks of getting the Johnson & Johnson vaccine. One 45-year-old woman died and three women remain hospitalized, with two in intensive care units, the committee was told.None of the cases were in Arizona.
After nearly four hours, the committee opted not to vote, which means that Tuesday’s recommended pause on the use of the vaccine remains in effect until their next meeting in about a week. The pause was first recommended by the CDC and the U.S. Food and Drug Administration. Several states, including Arizona, soon followed with similar recommendations.
The committee’s decision to maintain the pause was meant to provide time to see if additional cases are reported and to better analyze the known data and the risk-benefit level of the vaccine. Officials said there is no reason for increased concern, but rather the pause is to better understand the risk before providing recommendations about how the vaccine should be used.
Dr. Tom Shimabukuro of the CDC COVID-19 Vaccine Task Force emphasized that the pause was an example of a success story for vaccine safety because the system worked the way it is supposed to work, with adverse events reported and investigated.
Committee members said the pause does not mean people won’t be able to get vaccinated, as the Pfizer and Moderna vaccines, which use a different vaccine technology called mRNA, have shown no evidence of being associated with the rare blood clots that were reported with the Johnson & Johnson vaccine.
While J&J doses have made up fewer than 5% of vaccines administered nationwide, “we highlight that the Janssen has occasionally be used in populations that may be difficult to reach with mRNA vaccines that would require freezer temperatures or two doses,” Dr. Sara Oliver of the CDC said in a presentation to the committee.
Oliver said the “risk window” for developing the rare blood clots post-vaccine appears to be about two weeks in the six reported cases. That means there could be some cases of rare blood clots among the more than 3.7 million Americans who received doses of Johnson & Johnson within the last two weeks.
“These individuals would still remain within their risk window,” she said. “There may be more cases identified in the coming days to weeks.”
While the six reports of cerebral venous sinus thrombosis (CVST) in combination with low levels of blood platelets (thrombocytopenia) after the Johnson & Johnson vaccine were rare, extending a pause on the vaccine could allow for more specific recommendations, including evaluating the risk by age.
“However, extending the pause could have broad consequences. Individuals may want to receive the Janssen vaccine,” she told the committee. “In addition, a pause could have global implications such as pausing clinical trials or limiting the ability of the Janssen vaccine in other countries with more limited vaccine supply.”
Will Humble, executive director of the Arizona Public Health Association and a former state health director, watched Wednesday’s meeting and said he was disappointed there wasn’t more talk of how an indefinite pause might impact “health equity and special populations.”
Humble said part of the committee’s thinking appeared to be to protect the CDC’s Advisory Committee on Immunization Practices as an institution.
“If you look at it from ACIP’s perspective, if they recommend to continue using the vaccine and there are additional (blood clot) cases and they get on national television, then they get blamed for making the recommendation to allow it,” Humble said. “But if they make the alternative decision to withhold the vaccine and keep it in refrigerators, they are not the ones that get pinned for the farmworker who gets COVID and dies.”
The Johnson & Johnson vaccine is generally the preferred vaccine for Arizonans who use federally qualified health centers, said Tara McCollum Plese, chief external affairs officer for the Arizona Alliance for Community Health Centers.
Plese said the “one-and-done” advantage of the Johnson & Johnson vaccine captures a broader array of people who may not come back for a second dose. The strategy for reaching special populations such as people who are homebound and other people who could benefit from the one-dose will need to be shifted given the pause, she said.
Community health centers in Arizona are pausing the use of the Johnson & Johnson COVID-19 vaccine in keeping with both the federal recommendation and a recommendation from the Arizona Department of Health Services. So far it does not appear any doses will be wasted because the Johnson & Johnson vaccine can be safely stored for several months, Plese said.
“It’s not even a freezer, it’s a fridge you need to store it. It can be taken in a mobile unit. The cold chain is a lot easier,” Humble said. “I’m OK with them putting it on pause for a month if they had a discussion about what that decision would do to difficult-to-reach populations, for which this vaccine is uniquely useful.”
The decision not to vote seemed to be made from strictly a clinical perspective, which is extremely important, Humble said, but it did not also seem to take into account the downstream effect that pulling the vaccine could have on some populations.
Humble said he was grateful for input from Dr. Nirav Shah, who is not a voting member of ACIP, but who weighed in during the discussion portion of the meeting in his role as president of the Association of State and Territorial Health Officials.
Shah, who also is the director of the Maine Center for Disease Control and Prevention, said “not making a decision is tantamount to making a decision,” and that the pause could hurt vulnerable communities.
“Any extension of the pause will invariably result in the fact that the most vulnerable individuals in the United States, who are prime candidates for Johnson & Johnson vaccine, will remain vulnerable,” he said.
“The most at risk will remain at risk, and those who would benefit immediately from vaccination will remain unvaccinated for an unknown period of time. … I would urge that any pause be counterbalanced by consideration of the equity considerations that would befall from any lengthening of the pause.”
Johnson & Johnson vaccine: Did you get the J&J shot? Here’s what you need to know
Johnson & Johnson vaccine use in Arizona
Although the J&J vaccine has made up a very small portion of Arizona’s total vaccines — just about 3% of all doses administered in the state — it’s often been used strategically to target certain groups and get them vaccinated conveniently and quickly.
The news of the single-shot vaccine’s approval in late February was met with excitement by Arizona health officials, who saw it as a great way to quickly vaccinate frontline essential workers and hard-to-reach populations.
Dr. Cara Christ, the Arizona Department of Health Services director, at the time called it a “gamechanger” and recommended it for young, healthy frontline workers to make sure they were protected in their daily interactions with the public. This vaccine could do that quicker than the two-dose series, she said.
Christ also suggested it be used for agricultural workers who may move around for work.
Maricopa County targeted some of its J&J doses to immunize essential workers who may be difficult to get back for a second shot or for other groups that are harder to access.
The county held a three-day event in mid-March at a Phoenix high school to vaccinate public transit, U.S. Postal Service and funeral home workers with the one-shot vaccine.
The vaccine has been used to vaccinate agricultural workers in Cochise, Maricopa and Yuma counties. In late March, about 1,100 employees from eight farms in the West Valley received the Johnson & Johnson vaccine as part of the University of Arizona’s mobile health clinic at a Rosseau Farming facility.
The J&J vaccine was planned to be used this week to vaccinate individuals experiencing homelessness at a weeklong event at the Human Services Campus in downtown Phoenix. They switched Tuesday to Moderna because of the pause, but that means people will need to come back for second doses.
And it was used Saturday at a vaccine event put on by community organizations at South Mountain Community College in an area of Phoenix that has seen lower vaccine uptake. About 1,150 individuals were expected to be vaccinated with the single-dose vaccine at that event.
Maricopa County also sent J&J vaccine doses to county jails to immunize inmates. As of Wednesday, 1,392 J&J vaccines and 184 Moderna vaccines had been administered in county jails.
Dr. Joshua LaBaer, executive director of Arizona State University’s Biodesign Institute, said he hopes the pause will not be long given the usefulness of the J&J vaccine for certain groups.
“It’s a single-dose vaccine and so it has the benefit that you don’t have to bring people back a second time. Obviously, that was a reason for bringing it to hard-to-reach populations, was the logistical benefit,” he said at a Wednesday morning news briefing.
“They’re (federal officials) going to look at those (adverse reports) and see if there are others and then hopefully they can get back on track to getting that vaccine back out again. In the meantime, I’m hoping that we can look again at whether or not there are other ways to deliver the remaining vaccines to those populations where we need to get them vaccinated.”
Arizona this week was expected to receive just 12,000 doses of the Johnson & Johnson vaccine, down from the 101,700 delivered last week, because of manufacturing ebbs and flows, according to Christ.
Asked about the drop in doses at a Friday news briefing, before news of the pause, Christ said while the state has mostly used Pfizer and Moderna, J&J served an important purpose.
“I think that the reduction in Johnson & Johnson is unfortunate for trying to reach those hardly reached or underserved areas that it’s hard to get that second dose back. But we also were prepared for uneven distribution. We knew that for the first month or two, we’d get some weeks, and then the next week we might get none, so we’ve been focusing really kind of those mass planning events with the Moderna and the Pfizer.”
Dr. Camille Kotton, a member of ACIP and an infectious disease clinician at Massachusetts General Hospital, told the committee she agreed there was not enough data to make a decision but emphasized the importance of the J&J vaccine. She said its pause has been “devastating” for health care workers coordinating vaccines.
“We were planning on using this vaccine in the state of Massachusetts for people who are homebound and otherwise not able to get a vaccine. We were planning on using it for our vulnerable inpatient population, often with many comorbidities and at high risk for disease, but who haven’t been able to get vaccinated otherwise. And then it certainly was going to be used in what may be otherwise underserved populations or populations that aren’t able to get mRNA vaccines,” she said.
“I definitely want us to be cautious and very careful with our decision making, but I also just want to emphasize that this one-and-done vaccine that didn’t require the cold chain that the mRNA vaccines do — it’s a significant loss … for the underserved populations that did need access to this vaccine.”
Reach the reporter at [email protected] or at 602-444-4282. Follow her on Twitter @alisteinbach.
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