Pausing Johnson & Johnson’s COVID-19 vaccine may have been a good idea, a number of public health experts say, but now it’s time to allow the shots back on the market.
A number of experts said they expect a government advisory committee, which will meet Friday for the second time in less than two weeks, to lift the hold on the shot. Depending on what it learns about a mysterious blood clotting ailment, the committee might add an age restriction or simply a warning label to the vaccine.
“We all agree that the benefits outweigh the risks,” said Norman Baylor, president and CEO of Biologics Consulting and a former official with the Food and Drug Administration.
Last week, the committee said it didn’t have enough information about the clotting issue to make a decision. Friday, it is expected to have more and to decide whether to return the vaccine to the market and under what conditions.
The Centers for Disease Control and Prevention has reported eight cases out of more than 7 million J&J vaccine recipients of an ultra-rare combination of blood clots, many in unusual locations such as the brain, and low levels of platelets, which help wounds heal.
Typically, a health effect is determined to be caused by a vaccine if it occurs at a higher rate in the vaccinated population than among the unvaccinated.
In this case, the CDC could not come up with any rate in the general population. That and the presence of an antibody found in most of the sick patients’ bloodstreams, suggests the clotting-low platelet combination was caused by the vaccine.
Similar unusual events were seen among British and European recipients of a different COVID-19 vaccine, made by AstraZeneca and Oxford University, which uses a similar delivery system as J&J’s shots.
The European Medicines Agency, the equivalent of the FDA, said earlier this week that they had 25 reports of similar effects from the Pfizer-BioNTech vaccine and five from the Moderna vaccine. As of last week, the CDC said there were no cases among more than 80 million people who received those shots.
The CDC committee, called the Advisory Committee on Immunization Practices or ACIP, can recommend that the agency add a warning label to the vaccine about this very rare side effect, or limit its distribution to a certain group of people. Any recommendation from the committee would have to be approved by the CDC and the FDA.
The unusual side effect to both vaccines seemed to be striking only people under age 50, most of whom were women.
Vaccine experts doubt that the committee would recommend shelving the vaccine altogether, because the side effect is so rare.
The U.S. has paused its use of J&J’s COVID-19 shot.How will that impact vaccine equity?
CDC head Rochelle Walensky said Monday that while the agency has received more reports of medical conditions, it was still investigating whether they were connected to the shots, and was not hearing about a substantial number of new cases.
The agency paused use of the vaccine to draw attention to the problem, hoping to learn of more cases if there were any and also to warn doctors not to treat these patients with the drug usually used for blood clots, heparin, which can worsen these symptoms.
Many public health experts this week seemed convinced that the government had done the right thing by pausing the vaccine, though all felt it should now be allowed back into use.
“I want this vaccine back as soon as possible,” said Dr. Amesh Adalja, an infectious disease expert and senior scholar with the Johns Hopkins University Center for Health Security. “I was recommending it preferentially to my friends. One and done.”
Adalja, also a fellow with the Infectious Diseases Society of America, said on a Thursday IDSA call with the media that he hasn’t been a fan of the pause. He worried people would lose faith in the vaccine and that there were other ways to draw attention to safety concerns.
Others think the CDC and FDA made the right decision to pause vaccination, though they are eager to see it back in use.
People should put the very rare serious vaccine side effects into the broader context of the risks they face every day, like getting struck by lightening or hit by a car, said Ali Mokdad, a professor of Health Metrics Sciences at the University of Washington, speaking on the same call.
“These side effects are really minor,” he said. “Let’s be scientific about it.”
The single-shot vaccine is extremely useful for reaching marginalized people like those dealing with homelessness.
‘Swift action’ required:FDA issues withering report on problems at Emergent BioSolutions factory that ruined millions of J&J vaccines
“Johnson & Johnson is a game-changer for all of us,” Mokdad said.
The single-dose vaccine is also great for those who are afraid of shots, said Dr. Amy Baxter, a pediatric emergency room doctor at the Medical College of Georgia and an associate professor at Augusta University.
Many young adults – who were inundated with shots when they were little – remain afraid of needles, but also ashamed of their fear, she said. With vaccines widely available, anyone who still hasn’t gotten a shot probably harbors some needle anxiety, she added.
Baxter conducted an online survey on April 6 and again on April 15, so she was able to judge the shift in public opinion after the J&J pause.
“We did not find a huge drop in those willing to get vaccinated,” she said.
But she did find that 30% of people who said they would now get the Moderna or Pfizer-BioNTech vaccines instead vowed to only get one dose – which is less protective.
There are some very simple procedures that can help people get over needle hesitancy, she said, if vaccinators and public officials are paying attention: Things like distractions, not making fun of their fears and teaching people who worried about fainting how to maintain their blood pressure. “This part is addressable,” Baxter said.
Leaders of state public health agencies said they haven’t seen as much of an impact from the pause as they feared and hope that a short break in using the vaccine will not contribute much to vaccine hesitancy.
The clock strikes noon:America reaches milestone with COVID-19 vaccine widely available to those who want it, but hesitancy still casts a shadow
Dr. Nirav Shah, director of the Maine CDC, said he’s seen very little disruption in his state’s vaccination efforts.
Some people did call in to cancel when the state began providing the two-shot Moderna vaccine instead of the one-shot J&J, he said, speaking Wednesday to the Association of State and Territorial Health Officials, where he is the president.
But just as many signed up, saying they preferred Moderna. Programs that provided shots to the homebound were slowed, but are now switching to Moderna.
“I think what the pause suggests is that the safety system that we have in place worked,” Shah said. “Things were paused and now there’s a scientific question as to whether what we have seen is a needle in a haystack or the tip of an iceberg.”
Dr. Ngozi Ezike, Illinois Department of Public Health Director, said the pause has been largely positive.
“Anyone who was positing the theory that ‘they just quickly threw out these half-baked vaccines and they don’t even care what happens to us’ has obviously seen that that is not the case, that safety is the most important thing and that our safety and monitoring procedures in place are sensitive enough to pick up something that might only occur if one in a million shots,” she said. “And so I think that was reassuring.”
Some people, she said, looked at the one-in-a million risk and asked when could they sign up, while others learned the danger signs to look out for in case they do have a bad reaction to a shot. Either way, they felt empowered.
“I think we’re much better off than we were before the pause. And I think we will be able to recover,” she said. “I think we’ll have a population that is still going to be willing to take the J&J vaccine. And, of course, for those for whom the pause was a concern, we’re so happy that there are two other safe and effective vaccines that are available as well.”
Dr. Steven Stack, commissioner of the Kentucky Department for Public Health added that the vaccines are “far safer than taking your chances with COVID-19.”
“The evidence is very clear that all three of these vaccines are very protective,” he said.
Contact Karen Weintraub at [email protected]
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.