U.S. Can Resume Use of J&J Covid-19 Shot, Panel Recommends

“The benefits clearly outweigh the risks, though there are differences in age groups, and particularly for women less than 50 years of age,” said Dr. Katherine Poehling, a member of the Advisory Committee on Immunization Practices that made the recommendation, who is also a professor of pediatrics and epidemiology at Wake Forest School of Medicine.

The panel voted 10 to 4, with one abstention, in favor of lifting the recommended pause and restarting use among all adults.

J&J has agreed with the Food and Drug Administration to add language to the vaccine’s label warning about the clot risk, J&J Chief Medical Officer Joanne Waldstreicher told members of the vaccine committee during its meeting.

Dr. Waldstreicher said resumption of vaccinations with J&J’s shot would likely prevent many more deaths and hospitalizations from Covid-19 than the number of rare clot cases that may occur in people receiving the vaccine.

“We believe the J&J Covid vaccine is central to the effort to end the pandemic,” Dr. Waldstreicher said.

A Centers for Disease Control and Prevention official said that if vaccinations with J&J’s shot resumed, it could prevent up to 1,400 deaths from Covid-19 and up to 3,500 admissions to hospital intensive-care units over a six-month period, though there could be up to 45 cases of the rare blood-clot condition.

“Lifting the pause on J&J’s vaccine is in the best public-health interest of the U.S. population,” said committee member Henry Bernstein, who is also professor of pediatrics at the Zucker School of Medicine at Hofstra/Northwell.

J&J vaccine injections were put on hold after reports of a rare blood-clot condition in a small number of recipients, including at least three fatalities.

Many public-health authorities, however, contended that the benefits of the vaccine outweigh the risks. The risk of blood clots is much higher from Covid-19 disease than from the vaccines associated with these complications, Jean Connors, a hematologist at Brigham and Women’s Hospital in Boston, said in an interview.

Blood clotting all over the body is one complication of severe forms of the disease. About 15% to 20% of Covid-19 patients who are admitted to intensive-care units develop blood clots, Dr. Connors said.

Agreement by the FDA and CDC to lift the pause could put the vaccine back in circulation as early as this weekend, because millions of doses have already been distributed to vaccine sites.

Its availability could ease supply constraints that some areas and vaccination sites counting on J&J’s vaccine have experienced since its use was paused. It could also fulfill demand among people who prefer to get a single shot, rather than two doses spaced weeks apart required for protection from the Pfizer Inc. PFE 0.05% and Moderna Inc. MRNA 3.29% vaccines.

“I do think that there’s plenty of people who are interested in the J&J vaccine, if just for convenience as well as for a single-dose option,” CDC Director Rochelle Walensky said at a White House briefing before the vote.

Earlier in the week, Europe’s medicines regulator recommended adding warning language to J&J’s shot, but said its benefits outweighed its risks.

The Advisory Committee on Immunization Practices—which advises the CDC on vaccines and includes doctors and public-health officials—voted following a six-hour meeting. It was the ACIP’s second emergency meeting in 10 days to discuss the J&J vaccine.

The committee met April 14, one day after use of J&J’s vaccine was paused, but deferred voting on a recommendation because members wanted more information about the vaccine’s risks and benefits.

(More to Come)

—Betsy McKay, Eric Sylvers and Tarini Parti contributed to this article.

Write to Peter Loftus at [email protected]