The US Food and Drug Administration (FDA) has approved, under the emergency use authorization (EUA), two batches of Johnson & Johnson (J&J) subsidiary Janssen’s Covid-19 vaccine drug substance produced at the Emergent BioSolutions’ plant in Baltimore, US.
FDA’s decision comes after a thorough review and is part of the agency’s vital measures to make the Covid-19 vaccine available.
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Nearly ten million doses of the vaccine were authorised for use by the regulator, which also asked J&J to throw away several million doses manufactured at the Baltimore factory after finding that they were not fit for use.
In April, FDA released a report citing several unsanitary practices, including peeling paint, shoddy clean-ups and poorly trained staff at the Baltimore facility of Emergent, which is producing the vaccine.
The agency has so far not included the Baltimore plant in the Janssen EUA as an authorised manufacturing site.
As per the latest decision, the Covid-19 vaccine made with the drug substance from the Baltimore site can be used in the US or exported to various other countries.
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By GlobalDataThe expiration date for the refrigerated doses of this vaccine was extended by the FDA from three months to 4.5 months when kept at 2°C to 8°C.
FDA Center for Biologics Evaluation and Research director Peter Marks said: “These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product.
“This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s current good manufacturing practise requirements.”
Separately, Health Canada has said that owing to concerns with drug substance manufactured at the Emergent plant, it will not release the shipment of Janssen Covid-19 vaccines that were quarantined.
European Medicines Agency (EMA) also decided not to use batches of the vaccine produced when the contamination issues were reported at the Baltimore site.
Furthermore, South Africa’s Health Ministry will conduct additional checks on a batch of the Janssen vaccines made at this plant.
Meanwhile, Brazilian Health Regulatory Agency, Anvisa, held a meeting with Janssen representatives to consider expanding the expiry date of a batch of three million vaccine doses bought by the country.
