(WASHINGTON) — As federal advisers consider Friday whether Johnson & Johnson vaccine injections should resume after reports of rare blood clots, the Centers for Disease Control and Prevention now says there are 15 confirmed reports of blood clots with low platelet counts following the J&J vaccine, with a dozen of the clots occurring in veins near the surface of the brain — a condition called “cerebral venous sinus thrombosis.”
The number of these rare reactions is more than double the six cases initially reported that prompted federal regulators to recommend a temporary suspension of the vaccine, but they arise out of the nearly 8 million J&J shots given.
Dr. Tom Shimabukuro, a member of the CDC’s task force on COVID-19 vaccines, provided the update at a meeting Friday of an independent advisory panel that will help federal regulators decide whether to resume J&J vaccinations.
Last week, the government recommended a suspension of J&J vaccinations following the initial reports of blood clotting.
On Friday, Shimabukuro told the panel that all of the 15 cases discovered were women. Most of them were in their 30s, although the age range was 18-59. Three of the women died.
The panel’s decision Friday could pave the way to ending a 10-day nationwide “pause” that rattled younger women suspected of being more vulnerable to the dangerous reaction.
Among the options being weighed by the advisory panel is resuming shots with a medical warning or suggesting that certain groups of people — such as women under 50 — avoid the J&J shot.
The expert panel, which advises the Centers for Disease Control and Prevention, also could decide that they need more time and more data before making a decision. But that seemed unlikely, as administration officials this week signaled they expect an answer.
CDC Director Rochelle Walensky said Friday that after the “risk benefit analysis” is presented, “I think the FDA and I both feel strongly and the CDC … feel strongly that we need to act swiftly after that analysis.”
“I do think that there’s plenty of people who are interested in the day-to-day vaccine if just for convenience, as well as for a single dose option,” she said.
Dr. William Schaffner, a consultant to the advisory panel and chair of preventative medicine at Vanderbilt University, said all indications were that the committee was preparing to move forward after a decision last week to hold off.
“The expectation and hope is that the committee will indeed make a recommendation tomorrow. In other words, don’t kick the can down the road another two weeks,” he said Thursday.
Of the 7 million people who got the J&J vaccine, the CDC has identified six cases of women hospitalized for blood clots in the brain and low platelet counts after getting the injection. The women were between the ages 18 and 48, although it wasn’t clear whether there was a connection to age or gender.
Concerned the illnesses could be triggered by a rare but dangerous immune response by the vaccine, federal regulators on April 13 recommended a halt to the J&J vaccine.
In an emergency meeting last week, members of the advisory panel said they had too little data to make a recommendation either way, including whether younger women were more at risk. The advisers said they wanted to see if more cases emerged from the estimated 3 million people who received that vaccine in recent weeks before making a decision.
Since then, the CDC said a “handful” of additional cases are under investigation, but declined to provide details. The European Union’s drug regulatory agency said it reviewed U.S. data and determined a “possible link” to the rare blood clots, but believed the benefits outweighed the risks.
The nationwide suspension immobilized hundreds of federally run mobile clinics aimed at reaching the most vulnerable communities, leaving only nine operational.
“We’re not trying to scare anyone,” Dr. Jose Romero, chair of the Advisory Committee on Immunization Practices, told ABC News last week of the recommendation not to resume shots yet.
“We are simply trying to bring to the attention of the American public that this condition exists,” he added. “We want to reassure them, and we want to examine it and make a decision about the benefits of this.”
The disruption came at a critical time of the pandemic, with death and hospitalization rates tied to COVID-19 on the rise in nearly half the country. Health experts warned that variants of the virus were spreading more easily, impacting younger patients and that it’s critical to vaccinate the broader population quickly before new variants might take hold.
At the same time, federal regulators wanted to alert doctors and hospitals to be on the lookout for complications and to know how to treat them. Heparin, a commonly used blood thinner, appeared to worsen conditions.
Schaffner said the suspension of a life-saving vaccine because of six cases out of 7 million demonstrates that the system works when it comes to monitoring vaccine safety.
“It found a needle in a haystack and immediately called an emergency meeting,” he said, adding that the meetings were live-streamed to the public in the interest of transparency.
“This is really a system working very well, that I trust will give some people … a real appreciation and a sense of confidence in the process,” he said.
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