October 28 (Reuters) – An estimated 30 million to 50 million doses of the Johnson & Johnson (JNJ.N) COVID-19 vaccine manufactured earlier this year are unused at the plant of Emerging BioSolutions Inc (EBS.N ) in Baltimore pending the green light from US regulators to ship, two sources familiar with the matter said.
Emergent, a contract drug maker, is waiting for the US Food and Drug Administration to approve the release of these doses. The agency still needs to inspect and clear the plant before Emergent can ship a newly manufactured drug substance, one of the sources said.
The exact number of unused doses cannot be determined, the source said, because Emergent only manufactures the raw vaccine material and does not refill the finished product vials.
Emerging stocks opened nearly 1% more after the Reuters report.
In April, the FDA halted operations at the Emergent production facility after J & J’s vaccine was found contaminated with material from AstraZeneca’s (AZN.L) COVID-19 injections, which were there. also manufactured at the time.
The contamination ruined around 15 million doses of J&J and delayed the deployment of its vaccine in the United States by several weeks. Read more
Equipment made for the J&J vaccine at the Baltimore plant before the April shutdown and awaiting FDA approval could be enough to produce up to 50 million shots, the two sources said. They asked not to be named as they were not authorized to speak publicly on the matter.
Of the 100 million doses of Emerging vaccine material described at a Congressional hearing in April as shelved, the FDA has so far cleared nine lots of J&J vaccine and three lots of AstraZeneca. He did not disclose the number of doses contained in these lots.
Emergent announced in late July that it would resume production of J & J’s vaccine at the plant following further FDA reviews, but did not provide any updates on production or the timing of potential shipments. L1N2P535Q
Emergent has started making a new vaccine substance, but the FDA has yet to provide guidance on when it plans to inspect the Baltimore facility, one of the sources said.
The FDA said in a statement that it carried out a limited inspection of Emerging’s facilities in July to confirm that it had taken corrective action after the April production hiatus. A previous inspection had revealed a series of health, safety and poor manufacturing practices at the plant. Read more
The agency said it had not yet cleared the facility to ship doses and was continuing to review batches made before production ceased. It based its batch approvals on reviews of facility records and quality tests performed by the manufacturer.
The FDA typically waits for a drug manufacturing plant to produce multiple batches of its product before performing an inspection, according to a former FDA official who asked not to be named because she was not authorized to speak with the media.
Following the closure of the Emergent plant, J&J lowered its production target for 2021 to between 500 million and 600 million doses, from around 1 billion. He expects to be able to manufacture 1 billion doses per year from next year. Read more
J&J did not say whether it needs Emergent to restart production in order to reach its 2022 target. It has another manufacturing plant in Leiden, the Netherlands, and production agreements with others. contract manufacturers, including Catalent Inc (CTLT.N) and Biological E.
The United States has contracted with J&J for 100 million shots in 2020.
Last week, the FDA cleared J & J’s vaccine as a booster for people previously vaccinated but wanting additional protection against COVID-19, including anyone over the age of 18 who initially received the single-dose vaccine of the society.
Use of J & J’s vaccine has fallen sharply in the United States after being linked to a rare but potentially fatal blood clotting disorder.
Reporting by Carl O’Donnell Editing by Caroline Humer and Bill Berkrot
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