Pfizer and BioNTech announced Wednesday that they concluded exploratory talks with the European Commission for a proposed supply of 200 million doses of their investigational mRNA-based vaccine candidate against SARS-CoV-2, with an option to buy a further 100 million doses. The companies noted that deliveries of BNT162b2, which they say is on track to be filed for approval as soon as October, would start by the end of 2020, subject to clinical results and regulatory clearance.
Albert Bourla, CEO at Pfizer, remarked "we have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible." Doses for Europe would also be produced at BioNTech's German manufacturing sites. The companies said they will now enter into contract negotiations with the European Commission, which has so far only signed one advance purchase deal for a COVID-19 vaccine, agreeing last month to secure up to 400 million doses of AstraZeneca and the University of Oxford's AZD1222 candidate.
According to Pfizer and BioNTech, the proposed supply deal with the EU would represent the largest initial order of their vaccine to date. In July, the US government agreed to pay almost $2 billion for an initial order of 100 million doses of BNT162b2, with the possibility of acquiring up to 500 million more. The companies also agreed to supply 120 million doses to Japan, while the UK also recently struck a deal for 30 million doses.
A late-stage study is currently evaluating BNT162b2 at a dosage of 30 mcg as part of a two-dose regimen in up to 30,000 participants aged 18 to 85 years. Enrollment has so far exceeded 25,000 people with a second dose under way, the companies said, adding that they have already produced sufficient vaccine quantities for the trial and have started to manufacture and stockpile their pandemic supply as well.
Meanwhile, Pfizer and BioNTech say they have also made "an expression of interest" regarding supplying their vaccine to the so-called COVAX Facility, an initiative established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations and World Health Organization that aims to provide governments, including those in the emerging markets, with early access to a wide portfolio of COVID-19 candidate vaccines produced by multiple manufacturers. The EU has also recently signed on to COVAX, although the US is not participating.
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