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JOHNSON & JOHNSON

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Johnson & Johnson's Covid-19 Shot Set to be Given Again at Vaccination Sites -- Update

04/24/2021 | 02:53pm EDT

By Joseph Walker

Health officials around the country are preparing to resume offering Johnson & Johnson's Covid-19 vaccine as soon as this weekend after getting a green light from federal regulators on Friday.

The U.S. Food and Drug Administration and U.S. Centers for Disease Control and Prevention lifted their recommendation to pause the shots after investigating reports of rare but potentially dangerous blood clotting in certain recipients. On Friday, FDA and CDC officials said inoculations could continue because their benefits outweigh their risks.

Vaccinations can begin as soon as Saturday morning, said FDA's vaccines chief Peter Marks on a conference call with reporters Friday. The FDA issued updated informational guides that inform vaccine recipients and doctors of the risk of a blood-clotting side effect that has primarily affected adult women under 50. The overall risk is about 1.9 cases per million people, though the risk is about 3.5 times higher for women ages 18 to 49, officials said.

Doctors and public-health officials said it could take a few days to schedule appointments but welcomed the return of J&J's vaccine after last week's pause sent states scrambling to reschedule thousands of appointments.

"It does have some advantages over the other vaccines in particular populations where it may be difficult to give them a second shot," said Onisis Stefas, chief pharmacy officer at Northwell Health. "We really need to have multiple options out there to have people comfortable to get vaccinated so we can get to herd immunity."

Pharmacy chains Walgreens Boots Alliance Inc. and CVS Health Corp. said they would restart vaccinations with the J&J shot next week.

Arizona's health department said it had advised healthcare providers in the state to resume offering the J&J shot, of which the state has nearly 105,000 doses. The Minnesota Department of Health said the state had distributed 9,600 doses of the vaccine to healthcare providers that it expects to be available to the public in the coming days.

J&J's shot achieves immunity with one shot rather than two as required for Pfizer Inc.'s and Moderna Inc.'s vaccines. J&J's shot is easier to keep refrigerated and for longer periods.

States and hospitals are taking advantage of the simpler dosing to vaccinate people who are less likely or able to return for a second shot, such as the homeless, people who travel frequently for business, and older people confined to their homes.

J&J's vaccine supplies aren't as plentiful as its rivals because of manufacturing bottlenecks, but millions of distributed doses have yet to be administered, according to CDC data, and are a key tool to help speed the U.S.'s inoculation campaign.

Northwell will likely resume offering the J&J shot next week once it updates the informational materials it provides to patients to include a warning about blood clots and once it educates its doctors and nurses on how to communicate the risk to patients, particularly women under 50 years old, Dr. Stefas said.

Northwell, based in New Hyde Park, N.Y., had been using J&J's shot primarily for people discharged from the hospital and for nursing-home residents and plans to resume doing so next week, Dr. Stefas said. The hospital will assess how much demand there is from the general public before deciding whether to offer the shot at its public vaccination sites, he said.

"Just because we offer it doesn't mean people are going to take it," Dr. Stefas said. "We'll educate them on the risk, why the pause occurred and see if people are comfortable with taking the vaccine."

Yale New Haven Hospital in Connecticut hopes to restart offering shots to patients being discharged from the hospital or who visit the emergency room for conditions unrelated to Covid-19, said Chief Clinical Officer Thomas Balcezak.

The hospital runs several mass-vaccination sites around the state that are already booked next week with appointments to receive the Pfizer and Moderna vaccines, Dr. Balcezak said. Public-appointment slots for J&J's shot will likely be made available in the first week of May, he said.

Despite the blood-clot warning, J&J's shot will remain a preferred choice for some people, said Dr. Balcezak. Informal polling of patients and hospital staff after the past week's pause showed that some people are more comfortable with the vaccine because it doesn't use the relatively new messenger RNA technology used by Pfizer and Moderna, Dr. Balcezak said.

"Some of our employees say, 'I just want to have the J&J shot and be one and done,' or 'I like the idea that the technology is not mRNA," Dr. Balcezak said. "There's a lot of hesitancy regardless of the technology, so I don't know if this [pause] is going to add to it or not."

Washington state could restart J&J vaccinations as soon as this weekend pending a review of the latest FDA-CDC guidance by an independent committee of experts, said Umair Shah, the state's secretary of health. J&J's shots represented about 6% of all vaccine shots administered in the state when shots were paused last week; the state expects to receive an additional 8,600 doses over the first two weeks of May, he said.

Dr. Shah said he doesn't expect demand for the vaccine to be significantly less because the pause was short and the finding was that the blood-clot risk is extremely rare. Some pharmacies have reported receiving calls from patients requesting to be placed on a wait list to receive the J&J shot once the pause was lifted, he said.

"In general, this has not shaken confidence in the vaccine by many in the community," Dr. Shah said. "And every bit is going to help us, even a few thousand is helpful. People want it because it's one shot and they're not as concerned about the safety piece."

Write to Joseph Walker at joseph.walker@wsj.com

(END) Dow Jones Newswires

04-24-21 1653ET

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Sales 2021 92 812 M - -
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