Journal Editorial report: Paul Gigot interviews Dr. Marty Makary. Image: Michael Ciaglo / Getty Images
Red tape and delays have affected the early launch of the Covid-19 vaccine in Europe. But while European regulators seem to be learning from their mistakes, the Biden Administration seems to be repeating them.
Six cases of severe cerebral blood clots known as cerebral venous sinus thrombosis (CVST) in Johnson & Johnson vaccine patients last week prompted the Centers for Disease Control and Prevention and the Food and Drug Administration to recommend discontinuation of vaccines. Similar strokes have been linked to AstraZenecaS
vaccine, which uses a similar technology.
Agencies said the break was needed to notify health care providers how to treat unusual clots and give regulators time to review cases. Fair enough. FDA Interim Commissioner Janet Woodcock said the break would last only a few days, and the White House assured the public it would not thwart vaccinations. That’s not what happened.
The CDC convened a meeting of its Immunization Practices Advisory Committee – the same group that set the vaccine group’s priorities – last Wednesday to review the incidents and assess their significance. But this is not the rescue of the CDC, as Journal collaborator Scott Gottlieb pointed out on Monday.
The FDA collects safety information after the vaccine is approved and makes decisions about balancing the risks and benefits of medical products. It’s unclear why FDA officials were removed or why the CDC turned to a group of outside experts, but Dr. Woodcock and CDC director Rochelle Walensky could have sought political coverage.
Last week’s meeting provided some information. It was already known that the six cases involved women between the ages of 18 and 48 and occurred six to 13 days after vaccination. At the time of the break, 6.8 million Americans had received the vaccine, including about 1.4 million women in this age group. Even if more cases were reported, any adverse reaction would fade compared to the risk of Covid – as some panelists pointed out. A new study from the University of Oxford estimates that this rare type of cerebral blood clot has occurred at a rate of 39 million in patients with Covid.
FDA official Doran Fink told the panel that the vaccine could return to use, while scientists continued to investigate the cases, and the government informed patients and doctors about the potential risk. He suggested that the risk could be managed by including warning statements.
That’s what the European Medicines Agency did on Tuesday, after working with the FDA on its analysis. “The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the Covid-19 Janssen vaccine in preventing Covid-19 outweigh the risks of side effects,” the EMA said.
But the CDC panel was conflicted. Some experts feared that lifting the break could lead to more cases. The meeting was postponed without consensus, and the group plans to meet again on Friday to deliberate. The White House said the Pfizer-BioNTech and Moderna shootings will offset the lost supply.
But local officials across the country disagreed. “J&J has allowed us to reach out to marginalized people in New York – at home, New Yorkers are homeless, people are being released from hospitals, people in New York are being held,” he wrote on Twitter. New York, Mark Levine.
Perhaps the break will not delay the launch of the US vaccine if it is lifted on Friday. But the doctors’ decision. Walensky and Woodcock moving towards an inexplicable group of outsiders is a worrying development that seems to have posed a political risk to public health.
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It appeared in the printed edition of April 21, 2021.