Sympathy Move Imparts Momentum: Pfizer and BioNTech are developing an mRNA vaccine codenamed BNT162b2 against SARS-CoV-2, the virus that causes COVID-19.
A late Tuesday statement from AstraZeneca plc (NYSE:AZN) that said the company is pausing the late-stage study of its coronavirus vaccine due to one case of unexplained illness set in motion an across-the-board strength in vaccine makers, including Pfizer and BioNTech. Competitive pressure in the arena is intense, as companies toil to gain that first-mover advantage.
Vaccine Supply Talks: Pfizer and BioNTech said early Wednesday they have concluded exploratory talks with the European Commission to potentially supply 200 million doses of their vaccine candidate to member nations of the European Union. The contract being negotiated also carries an option for supplying an incremental 100 doses.
Once the final contract is negotiated, the companies expect deliveries to start by the end of 2020, contingent on clinical success and regulatory authorization.
"The proposed supply agreement with the European Commission would represent the largest initial order of vaccine doses for Pfizer and BioNTech to date," the companies said in the release.
Preclinical Data: Pfizer and BioNTech also announced preliminary preclinical data from BTN162b2 study, showing the investigational vaccine demonstrated protective anti-viral effects in rhesus macaques, with concomitant high neutralizing antibody titers and a TH1-biased cellular response in rhesus macaques and mice.
"The data we have shared today include the characterization of our lead candidate BNT162b2 as well as key animal studies that were the basis for our clinical programs. They have enabled us to advance BNT162b2 into Phase 3 evaluation," said Ugur Sahin, CEO of BioNTech.
BNT162b2 is currently being evaluated in a Phase 2b/3 study that targets enrolling up to 30,000 participants, ages 18-85 years, and the companies plan regulatory filing as early as October. The companies reported in early July positive preliminary results from a Phase 1/2 study.
Pfizer shares were rising 1.50% to $36.47 and BioNTech was rallying 6.89% to $63.95.