(Reuters) – Johnson and Johnson’s COVID-19 vaccine remained in limbo on Wednesday as a US health group called for more information before making a decision on how and whether to resume the use of a single shot dose, postponing a vote for a week or more.
The U.S. Centers for Disease Control and Prevention (CDC) advisory group decided to delay voting on how best to use the J&J feature even after a U.S. Food and Drug Administration scientist tell advisers he believed the warnings could mitigate the risk of extremely rare but severe blood clots.
The group is reviewing 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 stopping its use to assess the problem.
Dr. Lynn Batha, an epidemiologist with the Minnesota Department of Health, and several others spoke out in favor of extending the break to gather more safety information.
“By having more solid information, I think we can be more confident about how we talk about the safety of this vaccine,” he told other members of the advisory group.
Earlier, FDA Deputy Director for Vaccine Development Doran Fink told the group that her current thinking was that federal agency warning statements and communications would allow physicians to weigh the risks and benefits of vaccines. the vaccine.
However, other group members and advisers expressed concern that extending the break could worsen issues related to equitable access to the vaccine, which is considered important for serving hard-to-reach communities because it can be stored at room temperature. normal refrigerator and a dose instead of two.
“Any extension of the break will invariably result in the fact that the most vulnerable people in the United States will remain vulnerable,” said Nirav Shah, director of the Maine Center for Disease Control and Prevention and a representative of the State Health Association and Territorial. Officials told the panel. Shah is not a voting member.
Several members of the group wanted to vote to extend the break to a month, but Dr. Beth Bell, a global health expert at the University of Washington, argued she would send a global signal of a major vaccine problem.
“I don’t want to send the message that there is something fundamentally wrong with this vaccine, with which I disagree,” he said.
“It’s a very rare fact,” Bell said of cases of blood clots in the brain, known as cerebral venous sinus thrombosis (CVST), along with low blood platelets. “Nothing has risks.”
All six cases, all in women under the age of 50, were reported to be 7.2 million doses of the J&J vaccine given in the United States, a risk that federal health officials and immunology experts said was extremely low. especially when weighed against the possible ravages of COVID. -19.
One in six women died and three remain hospitalized. To date, more than 562,000 people in the United States have died from COVID-19.
Bell argued in favor of postponing a vote and gathering more information, which the group decided to do.
The FDA is accused of weighing evidence on the safety and effectiveness of a vaccine and could add warnings to existing labeling. The role of the group is to advise public health officials and the director of the CDC on how best to use vaccines once approved.
The FDA, in an email to Reuters, said it continues to review vaccine safety data, in collaboration 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 be followed so that the American public has confidence in the safety and effectiveness of vaccines,” the FDA added.
The group could recommend limiting the use of the vaccine to specific age groups to reduce the risks and is likely to give advice to health care providers on how to recognize symptoms and treat these patients.
One of the standard treatments for blood clots, heparin, can cause serious complications or death with this rare clotting condition.
Johnson & Johnson has not seen CVST in recipients of their Ebola vaccine or their respiratory syncytial virus (RSV) vaccine, which use similar technology, nor in their trial of a two-dose vaccine regimen. COVID-19, according to a company presentation to the vaccine advisory panel.
The group of outside advisers will make a decision before Friday on when it will meet again, which could be from a week to ten days, CDC officials said.
Reports by Susan Heavey, Mike Erman, Julie Steenhuysen, Manas Mishra and Dania Nadeem; Edited by Peter Henderson, Bill Berkrot and Grant McCool