The agreement extends Novartis’ earlier supply agreement for the fill and finish of more than 50 million doses at the Stein site in Switzerland


Novartis to produce Pfizer-BioNTech Covid-19 vaccine. (Credit: conorlinehan from Pixabay.)

Novartis has agreed with BioNTech to offer its manufacturing capacity and capabilities to support the fill and finish operations of the Pfizer-BioNTech Covid-19 vaccine.

Under the terms of the agreement, Novartis will take bulk mRNA active ingredient from BioNTech, and fill it into vials under sterile conditions.

The filled vials will be shipped back to BioNTech for distribution.

The Swiss drugmaker will use sterile manufacturing facilities at its Novartis Technical Operations site in Ljubljana, Slovenia, to produce at least 24 million doses in 2022.

Also, it is planning to transfer the manufacturing process from Stein to the Ljubljana site to start the fill and finish in the first half of 2022, subject to reaching a final agreement.

The site in Ljubljana is an advanced aseptic filling facility that manufactures and supplies a wide range of aseptic products for Sandoz, a subsidiary of Novartis.

The current agreement extends the earlier supply agreement for the fill and finish of more than 50 million doses in 2021 at the Novartis Stein site in Switzerland.

Novartis’ Stein site in Switzerland has started offering fill and finish operations for BioNTech from June after the European Union (EU) drug regulator EMA approved the plant.

In addition to the Pfizer-BioNTech Covid-19 vaccine, Novartis has also agreed with CureVac in March this year, to manufacture its mRNA Covid-19 vaccine candidate CVnCoV.

The Swiss drugmaker will produce the mRNA and bulk drug product for up to 50 million doses of the CVnCoV vaccine candidate by this year-end.

Earlier this month, CureVac has abandoned the development of its Covid-19 vaccine to focus on another shot it has been developing in partnership with GlaxoSmithKline (GSK).