AZN AstraZeneca PLC

By Peter Loftus 

Vaccinations with Johnson & Johnson's Covid-19 shot should resume, U.S. health regulators said after investigating rare blood-clotting cases, restoring a key tool for filling gaps in the mass vaccination campaign.

To alert doctors and recipients to the condition that led to a pause in the vaccine's use last week, J&J and regulators plan to add language to the shot's label and fact sheets warning of the clotting condition risk.

The U.S. Food and Drug Administration and U.S. Centers for Disease Control and Prevention on Friday lifted their recommendation to pause use of the shots, saying the benefits outweigh the risks. Their decision followed a vote by a federal vaccine advisory committee that recommended restarting use of Johnson & Johnson's Covid-19 vaccine in the U.S.

J&J's vaccine could be back in circulation as soon as this weekend because millions of doses have already been distributed, ending a pause that began last week and aiding some vaccination sites that wrestled with limited supplies after the shot was pulled.

Its availability could ease supply constraints that have cropped up since the pause at areas and vaccination sites that were counting on J&J's vaccine. 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. and Moderna Inc. 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 day's actions.

Yet the back-and-forth over the vaccine's use could also prompt some people concerned about safety to seek the other shots or even avoid getting vaccinated. After the FDA and CDC recommended to pause use of J&J's vaccine, health experts expressed concern the move could exacerbate hesitancy to get vaccinated.

J&J has agreed with the FDA 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 CDC 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.

"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.

After the ACIP's vote, J&J said the committee vote was an important step toward continuing vaccinations and the company will collaborate with health authorities to ensure the clot condition can be identified early and treated effectively.

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.

(More to Come)

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

Write to Peter Loftus at peter.loftus@wsj.com

(END) Dow Jones Newswires

April 23, 2021 19:38 ET (23:38 GMT)

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