(Reuters) – Johnson and Johnson’s COVID-19 vaccine went missing on Wednesday as the US Health Commission called for more data before deciding how and whether to resume the use of the single-dose shot, postponing voting for a week. or after.
The Centers for Disease Control and Prevention (CDC) advisory committee has decided to postpone the vote on how best to use the J&J shot, even after a U.S. Food and Drug Administration scientist told councilors he believed he believed warnings can reduce the risk of extremely rare but serious blood clots.
The panel looked at six reported cases of rare brain 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. Lin Bata, an epidemiologist with the Minnesota Health Department, and several others have called for an extension of the break to gather more safety information.
“With more reliable information, I think we can be more confident in the way we talk about the safety of this vaccine,” she told other members of the advisory panel.
Earlier, FDA Deputy Director of Vaccine Development Doran Fink told the panel that his current thinking is that warnings and reports from the federal agency will allow doctors to assess the risks and benefits of the vaccine.
However, other group members and advisers expressed concern that extending the break could exacerbate issues related to equal access to the vaccine, which is considered important for serving hard-to-reach communities as it can be stored at normal refrigerator temperatures and is given as one dose instead of two.
“Any extension of the break will inevitably lead to the fact that the most vulnerable people in the United States will remain vulnerable,” said Nirav Shah, director of the Center for Disease Control and Prevention in Maine and a spokesman for the State and Territorial Health Association. on the panel. Shah is not a voting member.
Several committee members wanted to vote to extend the break by about a month, but Dr. Beth Bell, a global health expert at the University of Washington, said it 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 that I do not agree with,” she said.
“This is a very rare event,” Bell said of cases of blood clots forming in the brain, known as cerebral venous sinus thrombosis (CVST), along with low blood platelets. “Nothing is risk-free.”
The six cases, all in women under the age of 50, were reported from 7.2 million doses of the J&J vaccine given in the United States – federal health officials and immunology experts said it was extremely low, especially when weighed against the potential destruction of COVID -19.
One in six women has died and three remain hospitalized. To date, more than 562,000 people in the United States have died from COVID-19.
Bell argued for postponing the vote and gathering more information, which the committee decided to do.
The FDA is responsible for weighing evidence of the safety and efficacy of the vaccine and may add warnings to existing labeling. The panel’s role 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 continues to review vaccine safety data, in partnership with the CDC, and will provide updates on additional scientific evidence as it becomes available.
“It’s important that these patient counseling processes are followed so that the American public has confidence in the safety and effectiveness of vaccines,” the FDA added.
The panel may recommend limiting the use of the vaccine to certain age groups to reduce the risks, and will likely issue advice to healthcare providers on how to recognize symptoms and treat these patients.
One of the standard treatments for blood clots, heparin, can lead to serious complications or death in this rare condition.
Johnson & Johnson has not seen CVST in recipients of its Ebola or Respiratory Syncytial Virus (RSV) vaccine using such technology, nor in a two-dose trial of the COVID-19 vaccine, according to a company presentation to the vaccine advisory panel. .
The group of external advisers will make a decision by Friday, when it will meet again, which could be within a week to 10 days, CDC officials said.
Report by Susan Heavy, Mike Herman, Julie Stenhuisen, Manas Mishra and Denmark Nadeem; Edited by Peter Henderson, Bill Bercrot and Grant McCool