The US F ood and Drug Administration (F DA) 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.
F DA’s decision comes after a thorough review and is part of the agency’s vital measures to make the Covid-19 vaccine available.
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, F DA 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.
The expiration date for the refrigerated doses of this vaccine was extended by the F DA from three months to 4.5 months when kept at 2°C to 8°C.
F DA 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 F DA’s current good manufacturing practise requirements.”
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.