Johnson & Johnson Asks FDA to Authorize Covid-19 Booster

Johnson & Johnson

JNJ 1.11%

has asked U.S. health regulators to authorize a booster dose for its Covid-19 vaccine, citing studies showing it improved protection among adults who previously received a single shot.

The Food and Drug Administration could decide on J&J’s request within weeks. The agency has scheduled an Oct. 15 meeting of an advisory panel to review the evidence of the need for a booster, and to recommend whether the agency should authorize one.

The advisers also are scheduled to review data on whether people who received one company’s vaccine could take a booster from another company. J&J’s request Tuesday was to authorize a J&J booster for people who had earlier taken the company’s one-dose vaccine.

The request is part of a broader but much-debated push to administer Covid-19 vaccine booster shots to address potential waning immunity from the original vaccines, and to combat the rapidly spreading Delta variant of the coronavirus.

The Biden administration has sought to roll out boosters broadly based on studies signaling waning immunity. Yet some infectious-disease experts have questioned the need for broad-based boosters, citing data that shows the original vaccines continue to protect people against severe disease even if they don’t stop all infections.

The FDA in September authorized a third dose of the Covid-19 vaccine from

Pfizer Inc.

and

BioNTech

SE in many adults, to be given at least six months after people get the original two-dose series.

Moderna Inc.

also has asked the FDA to authorize a third dose of its vaccine, and the agency could decide on that request soon.

Unlike the two-dose vaccines from Pfizer and Moderna, J&J’s vaccine was authorized in late February to be administered in a single dose to adults, based on a large international study showing it was 66% effective at preventing symptomatic Covid-19 disease and 85% effective against severe to critical cases of Covid-19.

J&J has since found that a second dose, at varying intervals, could sustain protection, and has shared the data with the FDA.

The company ran a separate international study in which subjects received two doses of its vaccine 56 days apart. The study found the two-dose series was 75% effective against symptomatic Covid-19 disease overall and 94% effective in the U.S. portion of the study. And the two-dose series was 100% effective against severe to critical cases, J&J said.

J&J also tested a booster dose given six months after the first dose. It found that the second dose boosted levels of immune-system agents known as antibodies significantly in the weeks following the booster.

“We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters,” said Mathai Mammen, global head of research and development at J&J’s Janssen pharmaceutical unit.

The company said its single-dose vaccine remains effective against Covid-19, citing data showing the various measures of immune response were strong and stable up to eight months after vaccination.

J&J’s Covid-19 vaccine hasn’t played as large a role in the U.S. mass vaccination campaign as originally hoped. So far, only about 15 million doses have been administered, compared with more than 152 million Moderna doses and 229 million Pfizer doses, according to the Centers for Disease Control and Prevention.

J&J has encountered manufacturing problems, as well as a pause in vaccinations during April while health authorities probed a rare but serious blood-clot disorder among vaccine recipients.

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

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