Tuesday, September 21, 2021

U.S. authorities probing Emergent BioSolutions over COVID-19 vaccine issues – filing

Must read

WASHINGTON (Reuters) -Drug manufacturer Emergent BioSolutions Inc said on Friday it has received inquiries and subpoenas from a swathe of U.S. authorities related to its abilities to manufacture COVID-19 bulk drug substance.

Emergent came under regulatory scrutiny after an error led to millions of vaccine doses being ruined at its manufacturing facility in Baltimore, which was producing bulk drug substance for Johnson & Johnson’s COVID-19 vaccine.

The U.S. Food and Drug Administration (FDA) in April halted operations at the plant after it discovered that ingredients from AstraZeneca’s COVID-19 vaccine, also being produced there at that time, contaminated a batch of J&J’s vaccines.

Emergent in a filing https://investors.emergentbiosolutions.com/node/20661/html on Friday said it has received “preliminary inquiries and subpoenas to produce documents” from the lawmakers, the Department of Justice, the Securities and Exchange Commission, the Financial Industry Regulatory Authority, and Maryland and New York Attorneys General.

The Department of Justice declined to comment on the matter.

Emergent said it was producing and has produced documents as required in response and will continue to cooperate with the government inquiries.

An FDA inspection in April turned up a long list of sanitary problems and bad manufacturing practices at the facility, including failure to train personnel to avoid cross contamination of COVID-19 vaccines from J&J and AstraZeneca.

Emergent said on Wednesday production at the Baltimore facility will now resume, following remedial actions, additional reviews and collaboration with the FDA and its manufacturing partners.

An FDA spokesperson said on Thursday the facility has not yet received any authorization for a COVID-19 vaccine, but may produce vaccine substance in advance of future inspections by the health regulator.

(Reporting by Chris Prentice in Washington and Manojna Maddipatla in Bengaluru; Editing by Bernard Orr and Shounak Dasgupta)

tagreuters.com2021binary_LYNXMPEH6T16B-FILEDIMAGE

Latest News