Big Pharma Takes on Vaccine Production

BioPharm International Editors

As demand for COVID-19 vaccines increases, Big Pharma offers its manufacturing capacity and expertise.

Big Pharma companies—including some with their own vaccine candidates in development—are taking on the production demands for COVID-19 vaccines by establishing manufacturing partnerships with sponsors of approved or late-stage vaccine candidates.

Novartis announced on Jan. 29, 2021 an agreement to fill vials with the bulk mRNA active ingredient for the Pfizer-BioNTech messenger RNA (mRNA) vaccine at its aseptic manufacturing facility in Stein, Switzerland. The filled vials will be shipped back to BioNTech for distribution.

When the agreement is finalized, Novartis will commence production in the second quarter of 2021 with initial shipment of finished product expected in the third quarter, the company said in a press statement.

Novartis also reported that it is in discussion with other companies about assuming additional manufacturing work including production of mRNA, therapeutic proteins, and raw materials for COVID-19 vaccines and therapeutics.

On Jan. 27, 2021, Sanofi and BioNTech announced an agreement in which Sanofi will give BioNTech access to its established infrastructure and expertise with the goal of producing more than 125 million doses of COVID-19 vaccine in Europe. The first supplies will be produced by Sanofi’s Frankfurt, Germany facility in the summer of 2021.

Scaling up for CureVac vaccine production

Although the company has not produced vaccines in its 160-year history, Bayer announced on Feb. 1, 2021 that in 2022 it would produce 160 million doses of CureVac’s mRNA vaccine, which is currently in Phase IIb/III trials. Initial doses produced at Bayer’s Wuppertal, Germany facility are expected by the end of 2021.

The manufacturing announcement expands on a January 2021 announcement that Bayer would provide CureVac with development, supply, and key territory operations support, leveraging Bayer’s expertise and infrastructure in clinical operations, regulatory affairs, pharmacovigilance, medical information, supply chain management, ­­­­­and country operations within the European Union and selected additional markets.

GlaxoSmithKline (GSK) announced on Feb. 3, 202 an agreement to support the manufacture in 2021 up to 100 million doses of CureVac’s first generation COVID-19 vaccine using GSK’s established manufacturing network in Belgium. The €150 million (US$180.4 million) agreement also expands an existing relationship for the companies to co-develop mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine, GSK reports in a press statement.

The agreement provides that GSK and CureVac will immediately contribute resources to develop and manufacture novel mRNA vaccine candidates, including multi-valent and monovalent approaches, designed to offer broader protection different SARS-CoV2 variants, and respond to future new variants. The target is to introduce the first next-generation vaccine in 2022.

Under the terms of the agreement, GSK will be the marketing authorization holder for the next-generation vaccine, except in Switzerland, and will have exclusive rights to develop, manufacture, and commercialize the next-generation COVID-19 vaccine in all countries except for Germany, Austria, and Switzerland, the company reported.

GSK and Sanofi vaccine delayed

In December 2020, GSK and Sanofi announced a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program following clinical trial results that showed a lower immune response in older adults compared with patients who recovered from COVID-19.In announcing the results, the companies said they would work to improve the antigen formulation and conduct additional trials in 2021.

Sources:

Bayer
GlaxoSmithKline and GlaxoSmithKline
Novartis
Sanofi