Pfizer Reaches Coronavirus Vaccine Deal With EU, Eyes October Review From Regulators

Pfizer and its German partner, BioNTech, said they could have as many as 1.3 billion doses of their BNT162b2 coronavirus vaccine ready by the end of 2021.

Pfizer Inc  (PFE) - Get Report said Wednesday that it had agreed to a deal with the European Union to supply as many as 300 million doses of its experimental coronavirus vaccine, which it hopes will receive regulatory approval as early as next month.

Pfizer, which is working with Germany's BioNTech  (BNTX) - Get Report to develop its BNT162b2 mRNA-based vaccine, said it could have as many as 1.3 billion doses ready by the end of 2021. The groups reached a $2 billion agreement with the Department of Health and Human Services and the Department of Defense in late July to provide 600 million doses to the U.S. government.

The agreement comes less than a day after U.K. rival AstraZeneca AZN, which is working on a coronavirus vaccine with researchers at Oxford University, paused its late-stage trials following an unexplained illness in one of its participants.

“Pfizer and BioNTech’s anticipated agreement with the European Commission is an important step forward in our shared goal to have millions of doses of a vaccine against COVID-19 available for vulnerable populations before the end of the year. We would like to thank the European Commission for its commitment and confidence in our development efforts,” said CEO Albert Bourla. “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, if our clinical trials prove successful and regulatory approval is granted.” 

Pfizer shares were marked 1.5% higher in pre-market trading following news of the EU deal, indicating an opening bell price of $36.547 each. ioNTech's U.S.-listed shares rose 5% to $62.80 each in pre-market trading on the Nasdaq.

Pfizer received 'fast track' designation by the U.S. Food and Drug Administration in July for its BNT162 vaccine candidates based on preliminary data from Phase 1 and Phase 2 studies earlier this month. Early data from the German trial of BNT162b1 are expected to be released in July, Pfizer said at the time.

Last month, Pfizer said preliminary results of the study that it said triggered a 'strong immune response' in human trials, an unveiled plans to to test the most promising of its four vaccine candidates on up to 30,000 participants in trials set for the United States and Europe.