Regulatory Limbo for Johnson & Johnson Vaccine Continues


since early March, more than 6.8 million people in the United States have received the Johnson & Johnson Covid-19 vaccine, a one-dose-only shot that offers robust protection against a deadly virus.

Of those people, six experienced serious blood clots within two weeks of receiving the shot, according to a joint statement released on Tuesday from the Food and Drug Administration and the Centers for Disease Control and Prevention. All were under age 50. (The tally has since risen to eight; seven are women.) Although the exact link, if any, between the clots and the vaccine remains unknown, the CDC called on an expert panel to review the situation. In the meantime, the CDC and FDA statement recommends “a pause in the use of this vaccine out of an abundance of caution.”

The recommendation sidelines, at least temporarily, one of the three Covid-19 vaccines approved for emergency use in the U.S. The decision received immediate blowback, most loudly from critics without a background in public health, who questioned whether a handful of extremely rare medical events merited such drastic action in the middle of a pandemic. “6 cases out of 7 million people. What a disaster. This is going to get people killed. And it’s going to create more vaccine hesitancy,” wrote the statistician and politics analyst Nate Silver in one widely circulated tweet.

The situation appears to be more complicated. All evidence indicates that the clots are extremely rare — far rarer than dying in a car accident, or contracting a severe or fatal case of Covid-19. But the exact incidence among certain demographic groups is unclear, in part because the U.S. does not have an efficient, centralized system for collecting such medical data. The Johnson & Johnson vaccine also relies on very similar technology to the AstraZeneca Covid-19 vaccine, which has drawn scrutiny from regulators in Europe over rare clotting incidents, also concentrated among women.

It’s also unclear whether the pause will harm trust in the vaccine more than some alternative situations that could have played out — for example, one in which reports of clots had instead circulated in the media and among advocates, but did not receive a swift and thorough government response. “While there is a lot of worry that anti-vaxxers will use this safety signal for their aims, this whole process — for anyone who actually follows it — should reassure people that these safety signals are picked up and are taken seriously,” the science journalist Kai Kupferschmidt wrote on Twitter.

The U.S. may even be perfectly fine without the Johnson & Johnson shot in its arsenal. Already, more than 95 percent of Covid-19 vaccinations in the U.S. are from the Pfizer-BioNTech and Moderna vaccines, which use a different technology to induce strong immune protection against Covid-19. Meanwhile, supply of those shots is growing quickly; just this week, Pfizer announced that it would deliver 50 million additional doses to Europe months ahead of schedule.

The biggest concern may lie outside the U.S. Like the AstraZeneca vaccine, the Johnson & Johnson vaccine is easier to transport and store than the Pfizer-BioNTech and Moderna vaccines, and expert say it could be critical for reducing the global impact of a disease that has killed close to 3 million people worldwide. Indeed, the pause, the CDC-convened committee noted in a slide during a meeting this week, “could have global implications” — including hampering availability of the vaccine “in other countries with more limited supply.”

Also in the News:

• On Tuesday, the defense began presenting its case in the Derek Chauvin trial, heightening an ongoing fight among forensic pathologists over allegations of racial bias in their field. Chauvin, a White former Minneapolis police officer, is facing multiple charges for the death of George Floyd, a Black man who died in police custody in May 2020 after Chauvin kneeled on Floyd’s neck for nine minutes and 29 seconds. Citing autopsy results, Minneapolis prosecutors initially said that Floyd had died from heart failure as Chauvin restrained him and compressed his neck. But they also listed underlying health issues and drug use as contributing factors. Critics charged that the findings — by seeming to imply that Floyd’s own choices had played a role in his death — exhibited racial bias, which, as The New York Times reported this week, “helped expose long-simmering tensions within the small but influential world of medical examiners.” One recent flashpoint is a paper, published in February in the Journal of Forensic Sciences, finding that forensic pathologists assess certain autopsy cases differently based on the race of the deceased person. Forensic pathologists who are potential defense witnesses in the Chauvin trial have called, unsuccessfully, for the paper’s retraction. The outcry came as a surprise to one of the paper’s authors. “I was kind of blown away by what appears to be very irate reaction,” Joye Carter, a forensic pathologist at the San Luis Obispo Sheriff-Coroner Division in California, told the Times. “And I’m not sure if everyone has truly read the article for what it is.” (The New York Times)

• The prestigious National Academy of Sciences (NAS) may be on the verge of expelling two of its famous members for sexual harassment, reports Science’s Meredith Wadman. The academy is adjudicating complaints filed against astronomer Geoffrey Marcy and evolutionary biologist Francisco Ayala, both of whom were previously found guilty of sexually harassing colleagues in Title IX investigations. Marcy, formerly of the University of California, Berkeley, and Ayala, formerly of the University of California, Irvine, were dismissed years ago from their respective university posts. But the effort to eject the two scientists from NAS only began last fall, under a new policy that allows members of the uber-elite club to be ousted for code of conduct violations. (Prior to the 2019 rule change, academy membership was for life.) Computational chemist François-Xavier Coudert lodged the complaints after a tense Twitter exchange with NAS President Marcia McNutt, who indicated that she couldn’t initiate the process herself and that she was “waiting for you to file complaints.” Some scientists say the moment is long overdue. “We are watching social change happening in front of our eyes,” NAS member Nancy Hopkins told Science. “It has been a long time coming.” (Science)

• As the number of coronavirus cases soars in some developing nations, the Russian Covid-19 vaccine, Sputnik V, is gaining traction internationally. Early on, a rushed approval process and alleged lack of transparency by Russian scientists in the development of Sputnik V led to widespread mistrust of the shot. Since then, peer-reviewed research has indicated the Russian vaccine is safe and effective, and Myanmar, Egypt, Iran, Pakistan, and other countries have recently approved its use. Joining the ranks is India, which this week became the 60th nation to approve Sputnik V, amid a Covid-19 surge that has overwhelmed many hospitals. The Russian vaccine has also been adopted by at least nine Latin American nations, an effort that has sometimes been slowed by regulatory obstacles. And the European Union, amid surging Covid-19 cases and poor vaccine rollout, is now assessing the effectiveness of the Russian jab. Growing acceptance of Sputnik V comes even as Russia struggles to administer it, with only 6 percent of its own population receiving at least one dose. And some doubts remain: Regulators in Slovakia recently raised concerns over the effectiveness and quality of 200,000 Sputnik V doses they received from Russia, triggering a diplomatic dispute between the two countries. (Multiple Sources)

• And finally: Last week, an international collaboration of 200 physicists, analyzing data from an experiment at the Fermi National Accelerator Laboratory, or Fermilab, announced that a subatomic particle called the muon appears to be more magnetic than predicted by the standard model of physics. Their announcement was met with a great deal of excitement, with researchers saying it could open new possibilities in the field by upending the current understanding of the laws of physics. “This is our Mars rover landing moment,” said Fermilab physicist Chris Polly. But another paper, which gained additional attention this week, threatens to undercut Fermilab’s discovery. The calculation, published by a group of 14 theoretical physicists known as the Budapest-Marseille-Wuppertal collaboration, suggests that the standard model of physics should actually predict a different value for the magnetism of the muon — a value that’s close to what the Fermilab experimenters have argued is a revolutionary finding. Still, some of the Fermilab collaborators remain skeptical of the new calculation, and confident in their results. (Science)

“Also in the News” items are compiled and written by Undark staff. Brooke Borel, Lucas Haugen, Sudhi Oberoi, and Ashley Smart contributed to this roundup.


Michael Schulson is a contributing editor for Undark. His work has also been published by Aeon, NPR, Pacific Standard, Scientific American, Slate, and Wired, among other publications.