The envisaged contract would involve the initial purchase of 200 million doses on behalf of EU Member States, with an option to purchase a further 100 million doses. Deliveries could start by the end of 2020, subject to clinical success and regulatory authorization.
This proposed supply agreement with the EU would represent the largest initial order of vaccine doses for Pfizer and BioNTech to date (its agreement with the US Government, made in July, covers 100 million initial doses for $1.95bn, with the option for a further 500 million).
Doses for Europe would be produced at BioNTech's German manufacturing sites, as well as at Pfizer's manufacturing site in Belgium.
European Vaccines Strategy: Moderna, AstraZeneca, Sanofi-GSK
BioNTech-Pfizer is the sixth company with which the European Commission has concluded talks. It follows those with Sanofi-GSK (300 million doses); Johnson & Johnson (200 million doses with the possibility for a further 200 million); CureVac (225 million doses) and Moderna (80 million doses with option for 80 million more) across July and August.
The first contract, signed with AstraZeneca for 300 million doses (with the option to purchase 100 million more), entered into force on August 27.
The European Vaccines Strategy – adopted by the Commission on June 17, 2020 - aims to secure high-quality, safe, effective and affordable vaccines for all European citizens within 12 to 18 months.
Advance Purchase Agreements with vaccine producers reserve or give Member States the right to buy a given number of vaccine doses for a certain price; as and when a vaccine becomes available.
The envisaged agreement with BioNTech-Pfizer would provide for the possibility for all EU Member States to purchase the vaccine.
Preclinical data released this week
Germany’s BioNTech and US-based Pfizer are developing a coronavirus vaccine, BNT162b2, a nucleoside-modified messenger RNA candidate that expresses the SARS-CoV-2 spike glycoprotein. This week it announced data from preclinical studies which showed that immunization of non-human primates (rhesus macaques) with BNT162b2 resulted in ‘strong anti-viral effects’ against an infectious SARS-CoV-2 challenge.
The vaccine is in a Phase 2/3 safety and efficacy clinical study, with more than 25,000 participants aged 18-85 in the US, Argentina and Brazil. Additional enrollement is planned in Germany, Turkey and South Africa.
Assuming clinical success, Pfizer and BioNTech intend to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.