Initially, some suggested the government could just issue a warning to consumers and doctors. They didn’t want to undermine confidence in vaccines given the danger of covid-19. But as they talked, two big worries emerged. They feared there might be additional cases of brain blood clots they didn’t know about. And what if the government didn’t act quickly, and as a result more people got the wrong diagnosis and treatment and were hurt or died?
Their unanimous agreement to recommend a pause in using the J&J single-shot vaccine early Tuesday morning set off a fierce debate. Critics suggested they were overreacting, predicting the result would be fewer people getting vaccinated and more dying of covid-19, the disease caused by the coronavirus. Others praised the federal officials for acting quickly on their concerns — especially since the conventional treatment with anticoagulant drugs can have serious harm. The argument suggested there are no easy answers in a pandemic that has posed one excruciating challenge after another.
Bruce Gellin, president of global immunization at the Sabin Vaccine Institute, questioned whether an “outright pause” was the right way to go. “It’s hard to unscramble the egg,” he said.
He said the key issue was to alert the medical community to be aware of clots associated with the vaccine — and of the need to treat them appropriately. He believes that could probably have been accomplished without a full pause, which might have a harmful longer term impact. He recalled a scare around the HPV vaccine in Japan that proved to be unwarranted but meant the program was never able to be reinstated.
Ezekiel Emanuel, an oncologist and chair of the department of medical ethics at the University of Pennsylvania, also expressed concerns about the action. “Let’s hope it doesn’t induce [vaccine] hesitancy,” he said. “We’re in a critical race with variants, and people are dying.”
The federal officials who made the decision said their goal was to be open and transparent with the public — and to ensure health-care providers know about a rare side effect that should be treated differently than ordinary blood clots.
“We don’t in the United States have a lot of tolerance for friendly fire, okay?” Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, said in a webinar Tuesday with the American Medical Association. “We know we are fighting a war against covid-19, and we know that covid-19 is a devastating foe. But we also know when our medical countermeasures injure people, we don’t have a lot of tolerance for that, and that tends to undermine vaccine confidence.”
Officials on the Zoom call Monday said they debated the tricky balancing act they faced. Given that people in the United States have access to alternative vaccines — the Moderna and Pfizer-BioNTech shots — that have not been linked to the clotting problem, the officials opted to be extremely cautious, said one individual who was not authorized to discuss the decision and spoke on the condition of anonymity.
The discussion was amiable — highly scientific without disagreements. Eventually they all agreed that “there is a tremendous need for vaccines but also a tremendous need for trust in the vaccine,” according to another official, who spoke on the condition of anonymity to describe the discussions.
Since the U.S. vaccination effort began Dec. 14, experts have been reviewing safety data on the vaccines from a variety of surveillance systems. Initial information about the clotting case was detected by a vaccine-monitoring system jointly run by the CDC and the Food and Drug Administration. By the weekend, the number of unusual cases, along with additional clinical information, raised “many, many concerns,” according to one CDC official involved in numerous meetings over the weekend and Monday with officials at the agency and the FDA, who spoke on the condition of anonymity because the conversations were private.
“That was like the ‘Oh my God moment,’" the official said. “And if that’s happening, then there is great urgency to let clinicians know, so that if they see patients, they do not treat them like they usually treat people with blood clots.”
On Monday afternoon, the vaccine safety subcommittee of the CDC’s vaccine advisory committee, which has been meeting weekly since last year, gathered for about two hours, according to one member, who spoke on the condition of anonymity because they were not authorized to share information. Based on that review, “the information was consolidated, and CDC and FDA convened to discuss the findings,” Anne Schuchat, the CDC’s principal deputy director, said in an interview.
At the time, the FDA was scrutinizing reported cases in Europe involving AstraZeneca, which is expected to apply soon for emergency-use authorization to distribute its vaccine in the United States. Officials were disturbed to see that the AstraZeneca cases and the J&J cases looked almost identical, except the AstraZeneca ones involved two men in addition to women, officials said.
Just after 8 p.m. a Zoom meeting began that included Health and Human Services Secretary Xavier Becerra; CDC Director Rochelle Walensky; David Kessler, chief science adviser for covid-19 at the Department of Health and Human Services; acting FDA commissioner Janet Woodcock; and Marks, whose FDA center handles vaccines.
They decided they needed to take more-drastic steps than simply issue a warning because they were worried some patients having adverse reactions might be misdiagnosed or given the wrong treatment. The typical treatment for blood clots, the anticoagulant heparin, can make things worse for the condition seen in the vaccine recipients. In addition, the officials wanted to “stimulate reporting” in case there are additional cases that could help clarify the syndrome or the factors that put some people at greater risk
On Wednesday, the full CDC advisory committee on immunization practices will meet to hear presentations about the safety data.
“We recognize that it came kind of quickly for the partners and the patients who had [vaccine] appointments scheduled,” said Schuchat. “But once we had the information and pulled together the concern about the potential ongoing harm if patients had this very rare, severe event and aren’t managed appropriately, it made us want to get the information out to the health-care community before additional vaccinations with this product continue.”
Officials say roughly 1 million women in that age group have received the J&J vaccine.
Regulators in Europe have been confronted with a similar conundrum involving the vaccine by AstraZeneca and the University of Oxford.
In some countries, after reports of blood clots began to come in, the authorities paused use of the vaccine. In some places, they have restarted use of the vaccine but restricted it to older people. For example, authorities in Britain, which never paused use of the vaccine, last week determined that the risks of covid-19 were greater than the risks posed by the AstraZeneca-Oxford vaccine to all age groups except for adults under age 30 and said those younger adults should be offered other vaccines.
Leslie Francis, a medical ethicist at the University of Utah, said that the particular risks from severe covid-19 for different population groups must also be factored into decisions like this one. The J&J vaccine slightly elevates risk in younger women, who are at lower risk for disease than other parts of the population, Francis said.
“You do have to think about distribution of risk,” said Francis, who believes overall that the pause makes sense to build trust in the vaccination process.
Fenit Nirappil contributed to this report.