CDC advisers seek more risk data before deciding on resuming vaccine
WASHINGTON — A federal vaccine advisory committee said Wednesday it wanted more data before deciding whether to resume use of Johnson & Johnson’s coronavirus vaccine, leaving in place a temporary pause federal officials had recommended because of a rare and severe type of blood clot identified so far among six of the 7.5 million people who received the shot.
The move means the singleshot Johnson & Johnson product will remain on the shelf for at least a week and a half.
At the hastily arranged emergency meeting a day after federal officials recommended a temporary pause in use of the vaccine, advisers to the Centers for Disease Control and Prevention agreed to reconvene within 10 days, acknowledging the urgency of making a decision about a vaccine that is a key part of the strategy to end the pandemic in the United States and globally.
The expert committee reviewed details about six cases of blood clots in women who were between the ages of 18 and 48. The women developed symptoms, most often headaches, six to 13 days after vaccination. One vaccine recipient, a Virginia woman, died in March, and another is in critical condition, health officials have said. Two have been discharged, and three remain in the hospital.
Instead of voting on a recommendation about whether and how the vaccination campaign
could be restarted, panel members said they wanted more information on the risks, cause and frequency of the rare brain blood clots. When the panel reconvenes, they could vote at that time to continue an overall pause or pause use for certain age groups or people.
“We are very fortunate because we have multiple other alternatives in the U.S. to help stop this pandemic. We have very good, wellproven alternatives where we are not seeing safety signals,” said Helen Keipp Talbot, an associate professor of medicine at Vanderbilt University and a member of the committee. “I think that puts us in a little bit of a different position, and we can be much more cautious and thoughtful and use the old model of, ‘ First, do no harm.’”
The vaccine has been viewed as a powerful tool for building immunity among vulnerable communities, such as homebound people or homeless populations who may not be able to return for a second shot. The decision will also almost certainly reverberate around the globe.
The vaccine was a large part of the U.S. vaccination strategy, and the drugmaker has delayed the rollout of its vaccine in Europe as the investigation continues. South Africa suspended use of the vaccine
“The extension of the pause will invariably result in the fact that the most vulnerable individuals in the United States who were prime candidates for the Johnson & Johnson vaccine will remain vulnerable. The most at risk will remain at risk, and those who would benefit immediately from vaccination will remain unvaccinated for an unknown period of time,” said Nirav
Shah, director of the Maine Center for Disease Control and Prevention. “That would come at a period where the United States is still logging 5,000 deaths in the past seven days across the country. at a time when there were 480,489 new cases just in the past seven days.”
A CDC official and an executive from Johnson & Johnson described the six cases in the greatest detail yet. All of the women were White, and only one person was taking hormonal contraceptives that can cause blood clots, suggesting that was not the reason for the clots.
Tom Shimabukuro, of the vaccine safety team at CDC, explained the rare, severe clots were especially alarming because they were accompanied by low levels of blood cells involved in clotting — a combination virtually unheard of among healthy, young people.
“We have a picture where we have clots forming in large [blood] vessels in the presence of low platelets, so it’s kind of a paradox here,” Dr. Shimabukuro said. “This is unusual — it usually doesn’t happen.”
The combination has also
been seen — rarely — among people who received vaccine developed by AstraZeneca and University of Oxford. Four of those vaccine recipients were treated with heparin initially, an anticoagulant that is not recommended because the events closely resemble an immune-triggered reaction to the drug that could worsen the clots.
Some of the women had blood clots in other parts of their body, and Dr. Shimabukuro said the agency would cast a wider net in looking for clotting accompanied by low levels of platelets.
In a company presentation, Aran Maree, chief medical officer for Janssen, the division of Johnson & Johnson that developed the vaccine, also presented data on two cases of clots in people who received vaccine in the clinical trial, one of whom was a 25-year-old man with a hallmark of the symptoms.
“I’d like to reiterate that, based on the current data, Johnson & Johnson believes the overall benefit risk profile for a vaccine is positive across the population for which it is authorized,” Mr. Maree said.