(Reuters) – Johnson & Johnson’s COVID-19 vaccine remained in limbo on Wednesday as a US health panel called for more data before making a decision on how and whether to resume use of the one-time injection, raising a vote in favor a week or more.
The advisory panel of the U.S. Centers for Disease Control and Prevention (CDC) decided to delay a vote on how best to use the J&J shot, even after a U.S. Food and Drug Administration scientist told advisers that he believed warnings could reduce the risk of extremely rare but serious blood. clots.
The panel reviews six reported cases of rare brain blood clots in women who received the J&J vaccine, a day after the FDA and CDC jointly recommended that their use be discontinued to assess the problem.
Dr. Lynn Batha, an epidemiologist with the Minnesota Health Department, and several others spoke out in favor of extending the pause to gather more safety information.
“By having more robust information, I think we can have more confidence in how we talk about the safety of this vaccine,” she told other members of the advisory panel.
Earlier, Doran Fink, the FDA’s deputy director for vaccine development, told the panel that his current view was that with cautionary statements and notices from the federal agency, doctors could weigh the risks and benefits of the vaccine.
However, other panelists and advisers were concerned that extending the pause could exacerbate issues related to equitable access to the vaccine, which is considered important for hard-to-reach communities because it can be stored at normal refrigerator temperatures and given as one dose instead of two.
“Any extension of the pause will invariably result in the most vulnerable individuals in the United States remaining vulnerable,” said Nirav Shah, director of the Maine Center for Disease Control and Prevention and a representative of the Association of State and Territorial Health Officials told the panel. Shah is not a voting member.
Several panelists wanted to vote to extend the break by as much as a month, but Dr. Beth Bell, a global health expert at the University of Washington, argued that this would signal a major problem with the vaccine worldwide.
“I don’t want to send the message that there is something fundamentally wrong with this vaccine that I disagree with,” she said.
“It’s a very rare event,” Bell said of the cases of blood clots in the brain, known as cerebral venous sinus thrombosis (CVST), along with low platelets. “Nothing is without risk.”
The six cases, all in women under age 50, were reported from 7.2 million doses of the J&J vaccine administered in the United States – a risk that was extremely low, according to federal health officials and immunology experts. especially when weighed against the potential devastation of COVID-19.
One of the six women died and three remain in the hospital. To date, more than 562,000 people in the United States have died from COVID-19.
Bell advocated postponing a vote and gathering more information, which the panel decided to do.
The FDA is tasked with weighing up evidence about a vaccine’s safety and effectiveness, and could add warnings to existing labeling. The role of the panel is to advise public health officials and the CDC director on how best to use vaccines once they are approved.
The FDA said in an email to Reuters that it will continue to review vaccine safety data, in conjunction with the CDC, and will provide updates on additional scientific evidence as it becomes available.
“It is important that these deliberative processes that protect patients are monitored so that the American public has confidence in the safety and effectiveness of vaccines,” added the FDA.
The panel could recommend limiting the use of the vaccine to specific age groups to reduce risks, and is likely to advise health care providers on how to recognize the symptoms in question and treat these patients.
One of the standard treatments for blood clots, heparin, can lead to serious complications or death in this rare clotting disorder.
Johnson & Johnson has not seen CVST in recipients of its Ebola vaccine or its respiratory syncytial virus (RSV) vaccine, using similar technology, nor in its trial of a two-dose regimen of the COVID-19 vaccine, a company presentation said to the vaccine advisory panel.
The group of outside advisers will make a decision Friday on when it will meet again, which could be within a week to 10 days, CDC officials said.
Reporting by Susan Heavey, Mike Erman, Julie Steenhuysen, Manas Mishra and Dania Nadeem; Edited by Peter Henderson, Bill Berkrot and Grant McCool