USA stops AstraZeneca vaccine production at Baltimore plant - NY Times

U.S. ousts Astra from factory, puts J&J in charge

The situation creates a major problem for the New Jersey-based health giant, which anticipated shipping up to 24 million doses of its COVID-19 vaccine from the Baltimore facility in April, the Times notes. The Health and Human Services Department has directed that the AstraZeneca vaccine will now be produced at another plant, although the official did not specify where.

The New York Times reported that AstraZeneca said in a statement it will work with President Joe Biden's administration to find an alternative site.

Emergent's Baltimore plant is one of two that are federally designated as "Centers for Innovation in Advanced Development and Manufacturing" and were built with taxpayer support. The company has partnered with J&J and AstraZeneca for their USA coronavirus vaccine supply chains. The company confirmed it was taking tighter control of the production process. Meanwhile, the measures Emergent put in place to "prevent contamination or mix-ups" had come up short, the investigator said.

Cases of rare blood clots identified after AstraZeneca Covid-19 jabs
This view is echoed by the World Health Organisation (WHO), which has urged countries to continue using the jab. On Thursday, Britain identified 30 cases of rare blood clot events following use of the vaccine.

A statement issued by Emergent and reported by The Washington Post said, "There are rigorous quality checks throughout our vaccine manufacturing processes, and through these checks a single batch of drug substance was identified that did not meet specifications and our rigorous quality standards".

Had this portion of ingredients been approved it would have contributed to vaccine production. "We isolated this batch and it will be disposed of properly". Officials have said it may take weeks to sort out whether other batches of vaccine were contaminated and for F.D.A. inspectors to determine whether the Emergent plant can be cleared to release any doses that it has made.

Emergent's Bayview plant is still waiting on an FDA manufacturing green light, though the company has already been producing millions of doses and shipping them to J&J's fill-finish partner Catalent, which itself snared authorization last week. Currently, only the one-dose regimen of the J&J jab is authorised in the US.

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