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J&J Says Covid-19 Vaccine Ingredient Batch Didn’t Meet

Quality Standards

By Peter Loftus and Thomas M. Burton

Updated April 1, 2021 8:41 am ET

Johnson & Johnson said one batch of the main ingredient for its new Covid-19 vaccine didn’t

meet quality standards at a contract manufacturer, and the doses weren’t distributed.

J&J said Wednesday it detected the problem while making quality checks at a plant belonging to

contract manufacturer Emergent BioSolutions Inc., which was in the process of starting up but

hadn’t finished making doses.

J&J has been making the main ingredient in vaccine doses for the U.S. at one of the company’s

own plants. The quality lapse didn’t affect those doses, which have been given to people in the

U.S.

And though it scrapped the problematic batch, J&J said it would be able to make enough doses to

meet production targets for the U.S. in the coming months.

J&J didn’t disclose the nature of the quality lapse or how many doses were affected.

Two people said the batch was contaminated. One of the people said the quality problem affected

approximately 15 million doses of the vaccine’s main ingredient, though it isn’t expected to

affect that many potential finished doses.

J&J has enough main-ingredient supplies elsewhere in its manufacturing pipeline to meet the

U.S. government’s supply targets, the person said.

The New Brunswick, N.J.-based company said it shared information about the issue with the

U.S. Food and Drug Administration. The FDA is investigating, according to a separate person

familiar with the matter.

Emergent declined to comment.

J&J’s vaccine was the third to be authorized for use against Covid-19, after shots from Pfizer

Inc. and its partner BioNTech SE and from Moderna Inc. Health authorities especially welcomed

the addition of the J&J vaccine, because it requires just one dose and is easier to store.

Supplies in the U.S. were expected to increase as J&J’s manufacturing network ramped up

production, accelerating a mass vaccination campaign that has been gaining steam.

The New York Times earlier reported that J&J doses were ruined because of an accidental mix-

up of ingredients at Emergent.

J&J said it detected the quality problem in a batch of its vaccine’s main ingredient that Emergent

was making.

Emergent, a contract manufacturer based in Gaithersburg, Md., has been making the main

ingredient for J&J’s vaccine at an Emergent plant in Baltimore.

The plant hadn’t been cleared by the FDA to make and ship finished vaccines, one of the people

said.

The problem batch of the vaccine’s main ingredient never advanced to the final, so-called filling

and finish stages of its manufacturing process, J&J said.

J&J said it is providing additional experts in manufacturing, technical operations and quality to

be on-site at Emergent to oversee all manufacturing of the J&J vaccine there.

J&J’s own plant in the Netherlands has been making the main ingredient for the initial U.S.

supply of its vaccine, including the nearly four million doses that were distributed immediately

after it was authorized in late February.

J&J said it was able to meet a target of delivering a total of 20 million vaccine doses for use in

the U.S. by the end of March.

The company said it expects to deliver an additional 24 million doses in April, and plans to have

delivered a total of 100 million in the first half of the year, aiming for meeting that target by the

end of May.