Government Vaccination – WSJ

According to the agencies, the break is necessary to notify healthcare providers of the treatment of unusual blood clots and give regulators time to review matters. Fair enough. FDA acting commissioner Janet Woodcock said the interruption would last only days, and the White House assured the public that it would not thwart vaccinations. That’s not what happened.

The CDC convened a meeting of its immunization practice advisory committee last Wednesday – the same group that set the vaccine group’s priorities – to investigate incidents and assess their importance. But this is not the CDC’s bail, as Scott Gottlieb, contributor to the journal, remarked in these pages on Monday.

The FDA collects safety information after vaccine approval and makes decisions about balancing risks and benefits of medical products. It is not clear why FDA officials were fired or why the CDC pointed to a panel of outside experts, but dr. Woodcock and Rochelle Walensky, director of the CDC, may have sought political coverage.

Last week’s meeting offered little insight. It was already known that the women between the ages of 18 and 48 were involved in the six cases and occurred six to 13 days after vaccination. By the time of the break, 6.8 million Americans had received the vaccine, including 1.4 million women in that age group. Even if more cases are reported, any side effects will pale in comparison to the risk of Covid – as some panelists have pointed out. A new study from the University of Oxford estimates that this rare type of blood clot in the brain occurred in Covid patients at a rate of 39 per million.

FDA official Doran Fink told the panel the vaccine could be used again while scientists continue to investigate cases and the government notifies patients and doctors of the potential risk. He suggested that the risk could be managed by including warning statements.

This is what the European Medicines Agency did on Tuesday after collaborating with the FDA on the investigation. “The reported combination of blood clots and low platelets is very rare, and the overall benefits of Covid-19 Vaccine Janssen to prevent Covid-19 outweigh the risks of side effects,” the EMA said.

But the CDC panel was conflicting. Some experts are concerned that lifting the break could lead to more cases. The meeting was adjourned without consensus, and the panel plans to meet again Friday to discuss. The White House said the Pfizer BioNTech and Moderna shots would compensate for the lost stock.

But local officials across the country disagree. “J&J has allowed us to reach marginalized NYers – homebound, NYs have experienced homelessness, people discharged from hospitals, locked up NYers,” tweeted New York City Councilman Mark Levine.

Perhaps the break will not slow down the rollout of the American vaccine much if it is lifted on Friday. But the decision by Dr. Walensky and Woodcock applying themselves to an unaccountable group of outsiders is a worrying development that appears to pose political risks to public health.