Health officials called for an immediate pause on use of the Johnson & Johnson COVID-19 vaccine Tuesday morning. This decision came after six recipients in the U.S. developed a rare disorder involving blood clots within about two weeks of receiving the one-dose vaccine.
All six of these recipients identified as women and were between the ages 18 and 48. One woman has died and a second person in Nebraska is in critical condition in the hospital.
Since the J&J vaccine was approved for emergency use in America by the Food and Drug Administration, nearly seven million people in the U.S. have received this vaccine. “We are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, and Anne Schuchat, MD, principal deputy director of the Centers For Disease Control and Prevention, said in a joint statement. “Right now, these adverse events appear to be extremely rare.”
On Wednesday, the CDC will convene an Advisory Committee on Immunization Practices (ACIP) to review these six cases and discuss whether they’re significant. After careful examination by the FDA and CDC, the health agencies will decide whether the vaccine should continue to be distributed to all adults, or if the authorization should be limited to certain populations or age groups.
The cases of blood clots, which occurred in conjunction with low platelet counts, first came to light late last week, and on Friday, Johnson & Johnson told Reuters they were aware of the issue, and were working with regulators to look over the data. In a statement sent to Refinery29, Johnson & Johnson said: “We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine... We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public.” The company added that it had also decided to proactively delay the vaccine rollout in Europe.
This news is being announced amid a surge in COVID-19 cases. The virus thus far has killed more than 2.9 million worldwide and can cause long-term health concerns. The national vaccine rollout has been largely well-received, and although vaccine hesitancy is less prevalent than it was in December, hesitancy or resistance to vaccination is still widespread enough to have experts concerned.
Some health official say the fact that the CDC and FDA have called for a pause on the J&J vaccine is a sign that our health systems are working, and of how seriously the agencies are taking safety. “This tells me that any possible adverse effects are getting reported up the chain of a command,” says Paul Pottinger, MD, a professor specializing in infectious disease at the University of Washington School of Medicine. “Those six cases, it’s a little less than one in a million, it’s incredibly rare, but the agencies are hitting pause so they can look at the data and decide if the association is true…. The overall safety of the vaccine has been shown to be strong, and the effectiveness is still very strong, so I’m hopeful the pause will be lifted so they can start getting the vaccine out and saving lives.”
“I know there are people who have gotten the vaccine who are probably very concerned,” Dr. Schuchat said in an FDA and CDC briefing Tuesday morning. “For people who got the vaccine over a month ago, the risk is very low at this time. For people who recently got the vaccine within the last couple weeks, they should be aware to look for any symptoms.”
If you received the Johnson & Johnson vaccine, Dr. Pottinger says that there’s no need to panic. But if you have any issues within three weeks of vaccination, report them to your doctor. Dr. Pottinger notes that in the 12 to 48 hours after the initial shot, it’s common to experience side effects such as headaches, fatigue, and muscle aches, and he emphasizes that it would be “incredibly rare” to experience this and have the reason be blood clots. But to be on the safe side, if you develop symptoms, especially severe headaches, leg pain, abdominal pain, or shortness of breath, anytime within a month of getting the vaccine, call your doctor or go to urgent care and tell them you’ve been vaccinated in the last month, he says, echoing FDA and CDC guidance.
“If you’ve had the Johnson & Johnson vaccine, I’d say, ‘Congratulations,’ because that means you're protected from a severe disease that can lead to hospitalization and death,” he adds.
There have been similar concerns in Europe and other countries about the COVID-19 vaccine developed by Oxford University and AstraZeneca researchers, which hasn’t been authorized yet in the U.S. It’s unclear exactly why these vaccines may cause the blood clots.
Federal officials noted in their release that the blood clots that people developed after the J&J vaccine were called cerebral venous sinus thrombosis (CVST), which are somewhat rare and require a different treatment than more common clots. “Usually, an anticoagulant drug called heparin is used to treat blood clots,” the statement said. “In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.”
There have been no significant safety concerns with the two mRNA vaccines by Pfizer/BioNTech and Moderna.
In the coming days, experts expect more details to come out about this pause, and its national and worldwide repercussions.
“It’s tragic that there was a death reported and another person is in critical condition,” M. Miles Braun, MD, an adjunct professor at Georgetown University School of Medicine and the former director of the division of epidemiology, CBER, at the FDA, tells Refinery29. “And at the same time large numbers of people are still dying of COVID every day in our country, so we need to try to balance and stay cognizant of all of these factors.”