Pharmaceutical giant Pfizer Inc. (PFE) and German biotech firm BioNTech SE (BNTX) said Monday that their coronavirus vaccine candidate, BNT162b2, was found to be more than 90 percent effective in preventing COVID-19 among patients without prior evidence of infection.

Following the news, shares of Pfizer are rising almost 16 percent or $5.75 in pre-market trade to $42.15.

The results were based on the first interim efficacy analysis conducted by an external, independent Data Monitoring Committee or DMC from the vaccine’s Phase 3 clinical study.

According to Pfizer and BioNTech, their mRNA-based vaccine candidate, BNT162b2, was found to be effective against COVID-19 in participants without prior evidence of SARS-CoV-2 infection.

“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,” said Dr. Albert Bourla, Pfizer Chairman and CEO.

The results comes as coronavirus cases continue to surge worldwide and economies struggle to reopen.

The late-stage clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date. Of the total participants, 38,955 have received a second dose of the vaccine candidate as of November 8, 2020.

The trial continues to enroll participants and is expected to continue through the final analysis, when a total of 164 confirmed COVID-19 cases have accrued. The interim analysis by DMC evaluated 94 confirmed COVID-19 infections among the trial’s participants.

The comparison of data between vaccinated individuals and those who received the placebo indicated a vaccine efficacy rate above 90 percent, seven days after the second dose was given. This means that protection from COVID-19 is achieved 28 days after the initiation of the vaccination, which consists of a two-dose schedule.

The DMC did not report any serious safety concerns and has recommended that the study continue to collect additional safety and efficacy data as planned.

The Phase 3 study will also evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease.

The companies plan to submit for emergency use authorization to the FDA after accumulating two months of safety data, which is expected to be available by the third week of November.

Based on current projections, Pfizer and BioNTech 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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