J&J Says Covid-19 Vaccine Ingredient Batch Didn't Meet Quality Standards -- 2nd Update
March 31 2021 - 9:21PM
Dow Jones News
By Peter Loftus and Thomas M. Burton
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.
At the same Baltimore plant, Emergent also makes the main
ingredient for AstraZeneca PLC's Covid-19 vaccine, which hasn't yet
been authorized for use in the U.S.
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.
Write to Peter Loftus at peter.loftus@wsj.com and Thomas M.
Burton at tom.burton@wsj.com
(END) Dow Jones Newswires
March 31, 2021 21:06 ET (01:06 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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