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Pfizer & BioNTech's COVID-19 Vaccine Candidate Shows Efficacy Rate Above 90% In Interim Analysis

Pfizer Inc. (PFE) and BioNTech SE (BNTX) said the first set of results from the phase 3 COVID-19 vaccine trial provides initial evidence of the vaccine's ability to prevent COVID-19. Following the news, shares of Pfizer were trading up more than 11 percent in pre-market.

The results were based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee from the phase 3 clinical study. The Committee has not reported any serious safety concerns.

Dr. Albert Bourla, Pfizer Chairman and CEO, said: "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 Data Monitoring Committee performed its first analysis when evaluable case count reached 94. The case split between vaccinated individuals and those who received the placebo shows a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

The phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020. The trial is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued.

Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

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