Inoculating the government – WSJ

Agencies said the pause 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 only be for days and the White House assured the public it would not frustrate vaccinations. That’s not what happened.

The CDC convened a meeting of its advisory committee on immunization practices, the same group that set the vaccine group’s priorities, to review the incidents and assess their significance. But this is not the rescue of the CDC, as Journal contributor Scott Gottlieb pointed out Monday.

The FDA collects safety information after the vaccine is approved and makes decisions about the balance of risks and benefits of medical products. It’s unclear why FDA officials were fired or why the CDC turned to a group of outside experts, but Dr. Woodcock and CDC director Rochelle Walensky may have been seeking political coverage.

Last week’s meeting offered some ideas. It was already known that all six cases affected 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 side effects would be alleviated compared to the risk of Covid, as some panelists pointed out. A new study from Oxford University estimates that this rare type of cerebral blood clot occurred at a rate of 39 per million in patients with covid.

FDA official Doran Fink told the group the vaccine could be reused as scientists continued to investigate cases and the government informed patients and doctors of the potential risk. He suggested that risk could be managed by including warnings.

This is what the European Medicines Agency did on Tuesday after working with the FDA on its review. “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 group was in conflict. Some experts worried that lifting the break could lead to more cases. The meeting was adjourned without consensus and the group is scheduled to meet again on Friday to deliberate. The White House has said Pfizer-BioNTech and Moderna features will make up for the loss of supply.

But local officials across the country have disagreed. “J&J has allowed us to reach out to marginalized New Yorkers: back home, the homelessness situation in New York, the discharge of hospitals and the imprisonment of New York citizens,” he tweeted to the Council member. New York City, Mark Levine.

Perhaps the pause will not delay the launch of the vaccine in the United States much if it rises on Friday. But the decision of Dr. Walensky and Woodcock for postponing unexplained groups of outsiders is a worrying development that seems to have put a political risk on public health.