J&J COVID-19 vaccine in tongue, while US panel delays shooting resumption

(Reuters) – Johnson and Johnson’s COVID-19 vaccine remained in the language on Wednesday, as an American health group requested more data before deciding on how and whether to resume using the single-dose vaccine, postponing the vote for a week or more.

FILE PHOTO: Ampoules with a sticker that reads, “COVID-19 / Coronavirus Vaccine / Injection Only” and a medical syringe are seen in front of a Johnson & Johnson logo displayed in this illustration made on October 31, 2020. REUTERS / Dado Ruvic

The U.S. Centers for Disease Control and Prevention (CDC) advisory panel has decided to postpone the vote on how best to use J&J fire, even after a U.S. Food and Drug Administration scientist -said to counselors that he believes the warnings could alleviate the risk of extremely rare but severe blood clots.

The panel looks at six reported cases of rare blood clots in women who have received the J&J vaccine, a day after the FDA and CDC jointly recommended discontinuing its use to assess the problem.

Dr. Lynn Batha, an epidemiologist with the Minnesota Department of Health, and others have spoken out in favor of extending the break to gather more safety information.

“With more robust 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 group.

Earlier, FDA Deputy Director of Vaccine Development Doran Fink told the commission that his current thinking is that the federal agency’s warning statements and communications would allow doctors to weigh the risks and benefits of the vaccine.

However, other members of the committee and advisers expressed concern that extending the break could exacerbate problems with equitable access to the vaccine, which is considered important for serving hard-to-reach communities as it can be stored at normal refrigerator temperatures and administered as a dose instead of two.

“Any extension of the break will invariably result in the most vulnerable individuals in the United States remaining vulnerable,” said Nirav Shah, director of the Center for Disease Control and Prevention in Maine and a representative of the State and Territorial Health Association. Officials told the commission. Chess is not a voting member.

Several members of the commission wanted to vote to extend the break by up to a month, but Dr. Beth Bell, a global health expert at the University of Washington, said she would send a global signal on a major issue. with the vaccine.

“I don’t want to send the message that there is something fundamentally wrong with this vaccine, which I do not agree with,” she said.

“It’s a very rare event,” Bell said of cases of blood clots in the brain, known as cerebral venous sinus thrombosis (CVST), along with low blood platelets. “There are no risks.”

The six cases, all in women under the age of 50, were reported out of 7.2 million doses of J&J vaccine given in the United States – a risk federal health officials and immunology experts said is extremely low. , especially when weighed against the potential ravages of COVID -19.

One of the 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 the vote and gathering more information, which the committee decided to do.

The FDA is accused of weighing the 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 CDC director on how best to use the vaccines once they are approved.

The FDA, in an email to Reuters, said it is continuing to review vaccine safety data in partnership 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 may recommend limiting the use of the vaccine to certain age groups to reduce the risks and is likely to provide advice to healthcare providers on how to recognize symptoms and treat these patients.

One of the standard treatments for blood clots, heparin, could lead to serious complications or death with this rare clotting condition.

Johnson & Johnson did not see CVST in recipients of its Ebola vaccine or respiratory syncytial virus (RSV) vaccine, which uses similar technologies, nor in the study of a two-dose COVID-19 vaccine, according to a company presenting the vaccine advisory group. .

The group of foreign advisers will make a decision by Friday on when it will meet, which could be in 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

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