U.S. Ends Pause on J&J’s Vaccine After Concern About Clots (2)

U.S. health agencies lifted the pause on Johnson & Johnson’s Covid-19 vaccine on Friday, 10 days after urging providers to hold off on using the shot while they reviewed serious and rare cases of blood clots among several people who received it.

The Food and Drug Administration and the Centers for Disease Control and Prevention said in a statement that they have determined that the pause that was put in place on April 13 should end and that use of the vaccine should resume. Inoculations can begin immediately, CDC Director Rochelle Walensky said in a briefing.

The agencies said that they found the shot was safe and effective at preventing Covid-19. They added that the chance of developing the rare blood-clot syndrome is very low, but that they will continue to investigate.

“This is not a decision the agencies made lightly,” FDA Acting Commissioner Janet Woodcock said in the briefing. Regulators issued a revised fact sheet for health-care providers with information about the risk of the syndrome. The agency has no objection to J&J restarting its trials of the vaccine, which were halted by the company, officials said.

Gearing Up

Pharmacies and hospitals are already gearing up to resume giving the J&J shot. CVS Health Corp. said it would restart giving the immunization at its chain of drugstores next week, and that all warnings and precautions will be communicated throughout the vaccination process.

Illinois providers who already received doses of J&J vaccine will be able to immediately begin administering them, the state said. Federal allocations of the vaccine will resume next week, and about 290,000 of 760,000 doses allocated to Illinois before the pause have been used.

Shereef Elnahal said the single-shot format is critical to communities served by University Hospital in Newark, New Jersey, where he’s chief executive officer. He’s ready to use the J&J vaccine as soon as new supplies reach his hospital.

“Newark is only at about 15% vaccinated,” said Elnahal, who’s former commissioner of the New Jersey Department of Health. “People can’t necessarily take a day off of work or show up to the hospital without transportation. So we’re scaling down our in-hospital clinic and taking the vaccine into the community.”

J&J rose 0.8% in trading after U.S. markets closed.

Health officials were under pressure to come to a decision on the shot during a 10-day pause that began after six cases of the side effect came to light. Now, a total of 15 cases of blood clots out of about 8 million doses administered have been reported, a CDC representative told a group of advisers to the agency in a meeting Friday. The panel voted to reaffirm their support of the vaccine’s emergency-use authorization, clearing the way for regulators to end the pause.

Some people want J&J’s “one-and-done” shot and others won’t have access to another vaccine in the near future, Walensky said. People should discuss their individual risk with their doctors or local health departments.

For women under 50, “this should certainly be an option,” Walensky said. “This risk trade-off is one people have to individually measure.”

Doses Ready

Health officials initially pursued the pause because they didn’t know how many cases were out there nor how many might emergence, since millions of shots had recently been administered, Woodcock said. They also wanted to ensure doctors knew how to appropriately treat the clots.

Nearly 10 million doses of J&J’s vaccine are ready to be used across the U.S., according to CDC data, but just how quickly they will find their way into people’s arms is unclear.

Momentum in the national immunization campaign appears to be slowing. Three million shots a day are now being administered, down from a peak of 3.4 million. About 40% of U.S. adults have already received one dose of a Covid-19 vaccine, and only 75% of the roughly 28 million doses being shipped out weekly would be used at the current pace.

Further, supplies of shots from Moderna Inc. and partners Pfizer Inc. and BioNTech SE are plentiful. The Biden administration has said it has enough shots between the two to meet expected demand for immunizations by the end of May.

EU Restart

Despite the abundance of vaccines, some public-health officials have said the J&J shot is helpful in reaching people in rural areas or others who have less contact with the health-care system. It only requires a single dose for full vaccination, and it can be stored at standard refrigerator temperatures.

The pause appears to have taken a toll on trust in J&J’s shot, with nearly a third of respondents saying they’d never take the single-dose vaccine, according to a poll from the de Beaumont Foundation, an advocacy group focused on public health.

Earlier this week, the European Union’s drug regulator suggested that the benefits of the J&J vaccine outweighed the risks. The European Medicines Agency said Tuesday that the clots should be listed as very rare side effects so that doctors and patients can look out for any danger signs.

Within hours, J&J resumed deliveries of the Covid-19 vaccine to the bloc. The EU deliberations, which moved more quickly than those in the U.S., set precedent for the Friday meeting of advisers to the CDC.

(Updates with agencies’ press conference in third paragraph, CVS statement in second section.)

--With assistance from Elaine Chen.

To contact the reporters on this story:
Angelica LaVito in New York at alavito@bloomberg.net;
Riley Griffin in New York at rgriffin42@bloomberg.net

To contact the editors responsible for this story:
Timothy Annett at tannett@bloomberg.net

John Lauerman

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