Week's news analysis

Covid-19 manufacturing: why agreements between Big Pharma speed up?

by the editor - 09 March 2021

With vaccination now well underway in every part of the world, it becomes more and more obvious that vaccine hesitancy is slowing down, whereas the need of millions of jabs is increasing. According to a Reuters tally of public statements and media reports, leading vaccine developers Pfizer-BioNTech, Moderna, AstraZeneca, J&J, Novavax, Russia's Gamaleya Research Institute, and CureVac are aiming to make enough vaccine with manufacturing partners to inoculate some 5.2 billion people in 2021.

At a recent hearing before the House Energy & Commerce subcommittee on Oversight & Investigations, leading vaccine makers outlined efforts to enhance production and packaging processes. Pfizer will boost vaccine shipments from 5 million to 13 million doses per week by the middle of March and still projects 2021 global production to reach 2 billion doses, almost double early estimates. Moderna plans to deliver millions of doses by the end of March and other increases leading to a total of 700 million doses this year, thanks to contract manufacturing with Lonza and Catalent. Johnson & Johnson now expects to provide 100 million doses of its single-dose adenovirus vaccine by the end of June 2021, starting with 20 million doses by late March.

But for pharmaceutical companies whose vaccines candidates have been approved by the FDA and/or the EMA, addressing global supply demands is getting more and more difficult. According to Sanofi CEO Paul Hudson, "the ability to get shots into arms is being limited by lower than expected supplies and delayed approval timelines owing to production shortages". Consequently, in spite of numerous contracts manufacturing with CDMOs, they all need to diversify their supply network. For the last weeks, several surprising agreements have loomed between big pharma to meet the challenge of mass production of vaccines.

Pharmanetwork tally of the latest announcements.

Johnson & Johnson

Beginning of March, Merck and Co, which discontinued its own plans to develop two COVID-19 vaccines after early clinical trial data showed an insufficient immune response, signed an agreement with Johnson & Johnson to help manufacture its single-dose coronavirus vaccine. Named Ad26.COV2.S, it was recently granted emergency-use authorisation by the FDA. Merck & Co will use two of its facilities for drug substance production and vial filling. In addition, Merck will receive up to $268.8 million of funding from the Biomedical Advanced Research and Development Authority (BARDA).

Mid-February, Sanofi also announced it will provide several manufacturing steps from Q3 2021 to help Johnson & Johnson supply needs. The French company will provide Johnson & Johnson access to the established infrastructure and expertise of its vaccine manufacturing plant in Marcy l'Etoile near Lyon, to formulate and fill vials of Janssen's COVID-19 vaccine candidate in 2021, at a rate of approximately 12 million doses per month. "While our priority remains advancing our two COVID-19 vaccine programs, we recognize there are opportunities to increase supply and expand access to Covid-19 vaccines", CEO Paul Hudson said. Sanofi is collaborating with Glaxo-SmithKline on a Covid-19 vaccine candidate using the same recombinant protein-based manufacturing technology as one of Sanofi's seasonal influenza vaccines, combined with GSK's established pandemic adjuvant platform. The companies initiated a new Phase 2 study in February 2021. In addition to the collaboration with GSK, Sanofi is developing a messenger RNA vaccine in partnership with Translate Bio.

Mi-January, several agreements were announced between Pfizer-BioNTech and Big Pharma in order to increase access to the vaccines. As a result, 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.

Novartis also partnered with Pfizer-BioNTech to leverage its manufacturing capacity and capabilities to supporting its production. The agreement will see Novartis utilizing its aseptic manufacturing facilities at its site in Stein (Switzerland). Under the terms of the contract manufacturing agreement, Novartis plans to take bulk mRNA active ingredient from BioNTech and fill this into vials under aseptic conditions for shipment back to BioNTech for their distribution to healthcare system customers around the world. Production will start in the second quarter of 2021 and first shipment of finished product is expected in the third quarter.

Another vaccine company is accelerating its vaccine manufacturing through partnerships. Germany's Curevac has signed agreements with GlaxoSmithKline to manufacture 100 million doses of its first-generation mRNA Covid-19 vaccine, CVnCoV, and to collaborate to develop a next-generation multi-valent Covid-19 vaccine aimed at emerging variants of the novel coronavirus. In February, Curevac also partnered with Bayer on the development of its first-generation mRNA vaccine. Bayer will add an additional 160 million doses of CureVac's vaccine in 2022 to further expand their supply network and overall capacity using their manufacturing network. 4th March, Novartis announced an additional agreement to manufacture Curevac's vaccine candidate CVnCoV, leveraging manufacturing capacity and capabilities to help address pandemic. The Swiss Big pharma plans to manufacture for up to 50 million doses by the end of 2021 and up to a further 200 million doses in 2022. Delivery from its manufacturing site in Kundl in Austria is expected to start in summer 2021. This site will be adapted to the needs of messenger RNA vaccine production for CureVac's CVnCoV, the manufacturing of which is highly complex.

In the meantime, several countries (mainly from Central Europe) decided to stop relying on the European Union to tackle mutant variants. Austria and Denmark have said they will work with Israel on second-generation jab. Austria thinks that the European Medicines Agency (EMA) has been "too slow" to approve vaccines and draws attention to production problems and delivery failures. " We must prepare for further mutations and should no longer be dependent solely on the EU in the production of second-generation vaccines," Chancellor Sebastian Kurz told the Austria Press Agency. So far, Austria has vaccinated a little under 5.5% of its population.

RELATEDCovid-19: The race for vaccine production capacities

Go to Top