After reporting stellar efficacy results for their vaccine candidate earlier this week, Pfizer Inc. PFE and BioNTech SE – ADR BNTX announced a supply deal with the European Commission.
What Happened: The U.S. pharma giant and its German partner said have reached an agreement with the European Commission to supply 200 million doses of their investigational mRNA vaccine, codenamed BNT162b2, against SARS-CoV-2.
The agreement requires the companies to supply the vaccine to EU member states, contingent on clinical success and regulatory authorization.
The agreement also carries an option for the EU to source an incremental 100 million doses.
Deliveries will likely start by the end of 2020.
Vaccine doses meant for Europe will be produced in BioNTech's German manufacturing sites as well as in Pfizer's manufacturing site in Belgium. Once the vaccine candidate is approved by the European Medicines Agency, EU member states, which have elected to receive the vaccine as part of the agreement will begin ordering, the companies said.
The binding agreement marks the conclusion of exploratory talks with the European Commission announced in early September.
Why It's Important: Pfizer by virtue of being the frontrunner is most likely to be the first-to-market. Analysts now see a probability of success of 100% for the vaccine candidate and estimate vaccine revenues due to Pfizer of about $4.6 billion to $7.2 billion in 2021.
What's Next? Pfizer/BioNTech look forward to applying for emergency use authorization after two months of safety data are accrued. This would most likely be in the third week of November.
Following EUA filing in the U.S., SVB Leerink analyst expects the FDA to convene an Adcom meeting by early-to-mid December, and accord EUA by late December.
The companies have already begun rolling BLA submission for the vaccine candidate in Europe.
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