Novartis and Allergopharma sites get EU OK to make Pfizer COVID vaccine

The European Medicines Agency (EMA) has approved sites in Switzerland and Germany for the fill and finish of Pfizer/BioNTech’s COVID-19 vaccine Comirnaty.

At the beginning of the year, Pfizer entered into a deal with fellow Big Pharma firm Novartis for the supply of its COVID-19 vaccine Comirnaty, codeveloped with German firm BioNTech.

Novartis is providing aseptic manufacturing services from its Stein, Switzerland, facility under a contract manufacturing agreement that sees the company take bulk mRNA active ingredient from BioNTech and fill this into vials, before shipping the vials back to BioNTech for distribution.

Novartis’ Stein, Switzerland site will hep supply Pfizer/BioNTech’s vaccine. Image c/o Novartis

The approval by the EMA’s committee for human medicines (CHMP) means the site can become operationally immediately.

A fill/finish site operated by Allergopharma GmbH in Reinbek, Germany has also been approved to support the vaccine.

Allergopharma entered into a contract with Pfizer/BioNTech last year and has been supporting Comirnaty production from its facility in Brehna, Germany since October. The firm said in April that its Reinbek plant – previously owned by Germany’s Merck – was gearing up to produce up to 40 to 50 million vaccination doses per month.

Approval of the two sites will support the continued supply of the COVID-19 vaccine within the European Union, though details regarding precise volumes have not been divulged.

However, the two sites will be a boon for Pfizer/BioNTech which are aiming to supply as many as 3 billion doses of its vaccine in 2021, and comes weeks after the EMA recommended the approval of additional manufacturing capacity at Pfizer’s own site in Puurs, Belgium.