FDA, J&J Near Deal for Covid-19 Vaccine Production at Baltimore Plant [View all]

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Source: The Wall Street Journal.

WSJ NEWS EXCLUSIVE HEALTH

FDA, J&J Near Deal for Covid-19 Vaccine Production at Baltimore Plant

Deal could allow 60 million doses of Johnson & Johnson’s vaccine to be cleared by FDA

By Thomas M. Burton
May 27, 2021 6:33 pm ET

WASHINGTON—The Food and Drug Administration and vaccine maker Johnson & Johnson expect to announce as early as Friday that contamination problems at a Covid-19 vaccine plant in Baltimore are resolved, clearing the way for millions more doses to become available.

Vaccine production at the plant run by contract manufacturer Emergent BioSolutions Inc. was halted after unsanitary conditions led to contamination of J&J vaccines. The facility made vaccine substance and finished vaccine doses for J&J and AstraZeneca PLC.

Emergent chief executive Robert Kramer told a House committee last week that the company had produced enough of a key ingredient to yield more than 100 million doses of the J&J vaccine.

The company has been taking corrective measures and been in talks with FDA and J&J over the steps needed to reopen the facility.

Johnson & Johnson said it is working with Emergent to secure “as quickly as possible emergency-use-authorization in the U.S. for Covid-19 drug substance manufactured at Emergent Bayview.”

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Read more: https://www.wsj.com/articles/fda-j-j-near-deal-for-covid-19-vaccine-production-at-baltimore-plant-11622154824

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The FDA and Johnson & Johnson expect to announce as early as Friday that contamination problems at a Covid-19 vaccine plant in Baltimore are resolved, clearing the way for millions more doses to become available

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