Shares of Pfizer Inc. (NYSE: PFE) rallied on Monday after the company reported positive results from its Phase 3 trial for its COVID-19 vaccine candidate. After jumping as much as 15% in premarket hours, the stock slowly pared its gains and was up 7% in morning trade. The stock has gained over 4% in the past one month.
Pfizer and its partner BioNTech SE (NASDAQ: BNTX) announced that their mRNA-based vaccine candidate BNT162b2 against COVID-19 displayed an efficacy rate of above 90% in participants with no prior evidence of SARS-CoV-2 infection.
According to the data, participants gained protection 28 days after the vaccine, which consists of 2 doses, was administered. The Phase 3 trial, which began by the end of July, has enrolled more than 43,000 participants to date. Approx. 39,000 of these participants have received a second dose as of November 8.
Albert Bourla, CEO of Pfizer, stated “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. 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. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”
The study will also evaluate the potential of the vaccine in patients who have been exposed to COVID-19 before as well as prevention against severe COVID-19 disease. The companies are working on preparing the data required for submission to the FDA. Based on current projections, Pfizer expects to produce up to 50 million doses in 2020 and up to 1.3 billion doses in 2021 worldwide.
Recent quarterly performance and outlook
Last month, Pfizer reported its third quarter 2020 earnings results in which revenues fell 4% year-over-year to $12.1 billion while adjusted EPS dropped 3% to $0.72. The company still saw strong performance from its key brands including Eliquis, Ibrance, Xeljanz, Inlyta and Xtandi.
For the full year of 2020, Pfizer has guided for revenues of $48.8-49.5 billion and adjusted EPS of $2.88-2.93.
Last week, Pfizer reported positive results from a Phase 3 study evaluating the efficacy of Xeljanz (tofacitinib) in patients with ankylosing spondylitis (AS). Tofacitinib has not yet received approval in the US for the treatment of AS. The company has submitted its application to the FDA and the PDUFA goal date is set for the second quarter of 2021.