The European Medicines Agency (EMA)’s committee for human medicine (CHMP) has given its approval for an additional manufacturing site to take on production of Johnson & Johnson’s COVID-19 vaccine, developed by its subsidiary Janssen.
The recommendation does not require a further decision from the EU Commission, allowing for the fill and finish of vaccines to take place at Catalent’s Anagni, Italy, site immediately.
The EMA noted that the work at the facility is expected to support additional supply of Janssen’s vaccine in the EU.
A spokesperson for Catalent confirmed to BioPharma-Reporter that production at the site had started the same day as the EMA’s statement.
In addition, they confirmed that the previously announced additional vial filling line, to expand the production capacity at the site for Janssen’s vaccine, was on track and “should be operational as originally announced”.
The original statement on the high-speed vial-filling line noted an expected operational date of the fourth quarter of 2021.
Increasing supply after manufacturing issues
Earlier this month, the EMA announced that it was aware of a contaminated batch of materials for another vaccine produced at Janssen’s partner’s facility in Maryland, US.
Emergent Biosolutions is responsible for the site, which produces vaccines for the EU market – though the contaminated batch was not intended for Europe.
As a precaution, the agency recommended not releasing vaccine batches containing the active substance made at around the same as the contamination event.
As a result of this, the supply of Janssen’s vaccine to Europe is expected to be below the figure originally projected by the end of June, after the company previously expected to deliver 55 million doses.
Janssen’s vaccine was approved in the EU back in March of this year, with the EU subsequently ordering 200 million doses. With Janssen’s vaccine only requiring one dose, this would have been enough to vaccinate 200 million individuals within the EU.