Pfizer-BioNTech Strike Deal With UK Government To Supply 30M Doses Of Coronavirus Vaccine

Coronavirus vaccine partners Pfizer Inc. PFE and BioNTech SE – ADR BNTX had incremental positive tidings concerning their mRNA vaccine candidate to combat SARS-CoV-2, the virus that causes COVID-19, sending shares of both companies sharply higher.

What Happened: Close on the heels of announcing positive interim Phase 1/2 readout, Pfizer and German partner BioNTech announced Monday an agreement with the U.K. government to supply 30 million doses of the vaccine candidates, codenamed BNT162, contingent on clinical success and regulatory approval.

The companies didn't disclose the financial terms of the deal, but hinted terms would depend on the timing of delivery and the volume of doses.

"This agreement is a testament to our shared goal to have millions of doses of a vaccine against COVID-19 available before the end of the year," said Albert Bourla, CEO of Pfizer.

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What's Next: The combo's vaccine program, codenamed Project Lightspeed, is evaluating four experimental vaccines, each representing a unique combination of mRNA and target antigen.

The companies will zero in on a lead candidate following further data from the Phase 1/2 trials, and also finalize the dose level for a global Phase 2b/3 safety and efficacy study that may begin as early as later this month, pending regulatory approval.

Two of the four candidates – BNT162b1 and BNT162b2 – have been accorded Fast Track designation by the FDA.

If the clinical studies prove successful, the companies plan to seek Conditional Marketing Authorization or some form of regulatory approval as early as October 2020.

"We are in advanced discussions with multiple other government bodies and hope to announce additional supply agreements soon," said BioNTech founder and CEO Ugur Sahin.

The companies hope to scale up manufacturing to make available 100 million doses by the end of 2020, and potentially more than 1.3 billion doses by the end of 2021.

In pre-market trading, Pfizer shares were advancing 3.59% to $37.55 and BioNTech was up 10.12% to $93.88.