(Reuters) -Johnson & Johnson’s COVID-19 vaccine was hit on Wednesday when a U.S. health panel asked for more information before deciding how and whether to resume single-dose use, and ‘ a week for a vote to be postponed. or more.
The advisory panel of the US Centers for Disease Control and Prevention (CDC) has decided to delay a vote on the best way to use the J&J survey, even after a US food and drug administration scientist told advisers has that he believes that warnings can reduce the risk of extremely rare but serious blood. clot.
The panel reviewed six reported cases of rare cerebral blood clots in women who received the J&J vaccine, a day after the FDA and CDC jointly recommended interrupting its use to assess the problem.
Dr. Lynn Batha, an epidemiologist at the Minnesota Department of Health, and several others spoke in favor of extending the break 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, the FDA’s deputy director for vaccine development, Doran Fink, told the panel that he currently thinks warnings and communications from the federal agency will enable doctors to weigh the risks and benefits of the vaccine.
However, other panel members and advisers have expressed concern that the expansion of the break could exacerbate unfair access to the vaccine, which is considered important for serving hard-to-reach communities, as it can be stored at normal refrigerator temperatures and given as one dose instead of two.
“Any extension of the break will always 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 a month, but dr. Beth Bell, a global health expert at the University of Washington, argued that this would be a sign of a major problem with the vaccine worldwide.
“I do not want to send the message that there is something fundamentally wrong with this vaccine, with which I do not agree,” she said.
“This is a very rare event,” Bell said of cases of blood clots in the brain known as cerebral venous sinus thrombosis (CVST), along with low platelets. “Nothing is risk-free.”
The six cases, all in women under the age of 50, were reported from 7.2 million doses of J&J vaccine administered in the United States – a risk federal health officials and immunology experts said was extremely low. was, especially when weighed against the potential devastation of COVID. -19.
One in six women is dead and three remain in hospital. To date, more than 562,000 people in the United States have died from COVID-19.
Bell pleaded for a postponement of a vote and for more information, which the panel decided to do.
The FDA is charged with weighing evidence on the safety and efficacy of a vaccine, and may add warnings to existing labeling. The panel’s role is to advise public health officials and the CDC director on the best way to use vaccines once they have been approved.
The FDA said in an email to Reuters that it is continuing to review the vaccine safety data, in partnership with the CDC, and that it will provide updates on additional scientific evidence as it becomes available.
“It is important that these deliberate processes that protect patients are followed so that the U.S. public has confidence in the safety and efficacy of vaccines,” the FDA added.
The panel may recommend that the use of the vaccine be restricted to specific age groups to reduce risks, and will likely provide advice to healthcare providers on how to recognize symptoms and treat patients.
One of the standard treatments for blood clots, heparin, can lead to serious complications or death with this rare clotting condition.
Johnson & Johnson has not seen CVST in recipients of its Ebola vaccine or the respiratory synthesis virus (RSV) vaccine, which uses similar technology, and according to a company under a two-dose regimen of the COVID-19 vaccine. submission to the vaccine advisory panel.
The group of outside advisers will decide by Friday when it will meet again, which could take up to ten days within a week, 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