Pfizer Inc. (PFE) - Get Report shares surged higher Monday after the drugmaker said it developing coronavirus vaccine was 90% effective in late-stage trials and plans to seek Emergency Use Authorization from U.S. health officials later this month.
Albert Bourla, Pfizer's CEO, said the vaccine's success could be the most significant medical advance the world has seen in the past 100 years.
Pfizer said it saw no serious safety concerns from its ongoing trial, the only major study not linked to the U.S. government's 'Operation Warp Speed' program, and expects to have as many as 1.3 billion doses produced next year if and when the drug is ultimately approved by regulators. In the interim, Pfizer said it would seek Emergency Use Authorization from the U.S. Food & Drug Administration in late November.
Pfizer received 'fast track' designation from the FDA in July based on preliminary data from Phase 1 and Phase 2 studies. Its Phase III trial should be concluded in early December, Pfizer said, with analysis from around 164 infections.
The 90% efficacy rate, Pfizer said, was identified from the 94 confirmed cases -- out of a study of more than 43,000 participants -- who received two doses of the vaccine.
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” Bourla said. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen."
'With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis," he added. "We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks."
European health authorities launched a 'rolling review' of the experimental vaccine the drugmaker is developing with Germany-based BioNTech last month and said they were evaluating the first batch of data from non-clinical studies of BNT162b2, the pair's mRNA-based coronavirus vaccine.
"We think the Street would have been very happy with the greater than or equal to 76.9% set by the protocols to announce efficacy results at the first interim look," said Cantor Fitzgerald analyst Louise Chen. "Based on this data we think the stock could trade to $40 to $40+, depending on if this is a one and done scenario or recurring revenue stream. If efficacy of ~90% holds in the final analysis, we may be looking at a one and done scenario."