Pfizer said two candidates from its BNT162 mRNA-based vaccine program, which it its working in collaboration with Germany's BioNTech Inc. (BNTX) - Get Report, were given the fast track designation 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.
“The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” said Pfizer's senior vice president of global regulatory affairs Peter Honig. “We look forward to continue working closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”
Pfizer shares were marked 2.84% higher in pre-market trading following the announcement to indicate an opening bell price of $34.79 each, a move that would extend the stock's year-to-date gain to around 12%. BioNTech's U.S.-listed shares rose 8.8% to $76.57 each n the Nasdaq.
Last week, Pfizer said preliminary results of its coronavirus vaccine 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.
No serious adverse effects were reported in the study, Pfizer said, which included testing of two BNT1162b1 doses on 24 healthy patient volunteers, but those treated showed higher levels of COVID-19 antibodies when compared to those infected by the disease.
If regulators ultimately approve the drug, Pfizer said, the two companies plan to manufacture up to 100 million doses by the end of the year, and "at least" another 1.2 billion by the end of 2021.