Friday, September 17, 2021


Johnson & Johnson says it will take full control of its coronavirus vaccine production at Baltimore plant

Johnson & Johnson will take full control of the production of its coronavirus vaccine at a troubled plant in Baltimore where millions of doses worth of drugs were contaminated, the company said late Saturday.



Production at the plant of the vaccine developed by AstraZeneca will be relocated with help from the Biden administration following the mix-up, according to AstraZeneca and a seniorfederal health official.

The developments followed the news that a batch amounting to 15 million doses of Johnson & Johnson's vaccine was spoiled at the plant after being contaminated with ingredients for AstraZeneca's vaccine.

The error was caught and no contaminated drugs made it out of the plant, according to the companies involved.

The plant is operated by Emergent BioSolutions, a major government contractor. The senior health official said the administration had determined that only one vaccine should be made at the facility.

Johnson & Johnson said in a statement that it was "assuming full responsibility" of production of its vaccine at the plant and that it was sending additional staff to Baltimore to oversee production.

"Specifically, the company is adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality and technical operations personnel to work with the company specialists already at Emergent," the statement said.

AstraZeneca said in a statement that it was working with the government to find an alternative location for production of its vaccine, which has not yet been authorized by U.S. authorities.

"AstraZeneca and the U.S. government continue to work closely together to support agreed upon plans for the development, production and full delivery of the vaccine," the statement said.

Johnson & Johnson said that it still expected to deliver 100 million doses of its single-shot vaccine to the U.S. government by the end of May. President Biden has pledged that all American adults will be eligible for vaccination by that time.

Emergent spokeswoman Nina DeLorenzo confirmed Saturday that the company had been notified that production of the AstraZeneca vaccine would be relocated and that Emergent intended to stop making the vaccine in the next few days.

"We are welcoming additional Johnson & Johnson personnel on-site at Bayview for their technical expertise and support," DeLorenzo said.

The changes in vaccine production at the plant were first reported Saturday by the New York Times.

Emergent's coronavirus vaccine production line has not yet been certified by the Food and Drug Administration. Until it is certified, vaccines made there cannot be distributed to consumers. Drugs made at the Baltimore plant have been set aside while the FDA reviews the Emergent plant.

The Washington Post reported on Thursday that an FDA investigator flagged problems at the Baltimore facility six weeks before the Trump administration announced a $628 million deal with Emergent as part of Operation Warp Speed, the government's program to rapidly produce vaccines to fight the novel coronavirus.

Emergent secured deals totaling more than $740 million with Johnson & Johnson and AstraZeneca to produce vaccines for both companies at the Baltimore site.

The Post reported last year that Emergent had benefited from billions of dollars in federal contracts as health officials directed public spending toward the threat of bioterrorism attacks at the expense of some preparations for a pandemic.

Emergent's Warp Speed deal was made as part of a long-standing contract between the company and the office in the Department for Health and Human Services responsible for preparing for public health threats.

At the time of the award, that office was led by Assistant Secretary Robert Kadlec. The Post previously reported that before joining the Trump administration, Kadlec was paid as a consultant to Emergent and formed a startup company with Emergent's chairman. Kadlec did not mention either role in a questionnaire about his career that he completed for the Senate when it considered his nomination by Donald Trump in 2017. Kadlec and Emergent previously told The Post that Kadlec's past work for Emergent had no bearing on the firm's government contracts.

Published : April 05, 2021

By : The Washington Post · Jon Swaine