Novartis, Sanofi Helping To Produce Pfizer-BioNTech Vaccine

By CodeBlue | 02 February 2021

Novartis will be carrying out the fill-and-finish process for the Pfizer-BioNTech Covid-19 vaccine, while Sanofi will be manufacturing over 125 million doses in Europe.

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KUALA LUMPUR, Feb 2 — Pharmaceutical companies Novartis and Sanofi have signed agreements to help manufacture the Pfizer-BioNTech Covid-19 vaccine, amid supply problems in the European Union (EU). 

Novartis, in their statement, on January 29 said that it will commence production in the second quarter of 2021 at its state-of-the-art aseptic manufacturing plant in Stein, Switzerland.

“Initial shipment of finished product is expected in the third quarter,” Novartis said in a statement. 

Under the agreement, Swiss pharmaceutical company Novartis plans to take bulk mRNA active ingredients from BioNTech and fill it into vials under aseptic conditions for shipment back to BioNTech to allow worldwide distribution.

“The Novartis manufacturing team is in advanced discussions with a number of additional companies to take on manufacturing activities such as mRNA production, therapeutic protein production as well as raw material production for Covid vaccines and therapeutics. The specifics will be disclosed once those discussions are concluded.”

The European Union has imposed export controls on Covid-19 vaccines, including the Pfizer-BioNTech vaccine, effective from January 30 to March 31. Hence, pharmaceutical companies must seek permission from the EU country where the Covid-19 vaccine is manufactured before supplying doses beyond the bloc, which can be rejected if member states believe EU supplies will be affected.

French pharmaceutical company Sanofi, in a statement on January 27, also said that they have signed an agreement with BioNTech to support manufacturing and supply of the Covid-19 vaccine.

“Sanofi will provide BioNTech access to its established infrastructure and expertise to produce over 125 million doses of Covid-19 vaccine in Europe. Initial supplies will originate from Sanofi’s production facilities in Frankfurt from summer of 2021,” Sanofi said.

“We are very conscious that the earlier vaccine doses are available, the more lives can potentially be saved. Today’s announcement is a pivotal step towards our industry’s collective goal of putting all the effort in to curb this pandemic,” Sanofi CEO Paul Hudson said.

“We have made the decision to support BioNTech and Pfizer in manufacturing their Covid-19 vaccine in order to help address global needs, given that we have the technology and facilities to do so. As always, our top priority is to focus our efforts and capabilities on fighting this global pandemic.”

Currently, Sanofi is collaborating with GSK on producing a Covid-19 vaccine candidate using the recombinant protein-based manufacturing technology and plans to start Phase Three trials in second quarter 2021. 

“Positive results from this study would lead to regulatory submissions in the second half of 2021, with potential availability of doses in the fourth quarter of 2021.”

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