Photo taken on Nov. 7, 2019 shows the booth of Pfizer Inc. during the second China International Import Expo (CIIE) in Shanghai, east China. (Xinhua/Fan Peishen)

Pfizer and BioNTech expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

WASHINGTON, Nov. 9  -- American drugmaker Pfizer and German pharmaceutical company BioNTech announced on Monday data analysis shows their COVID-19 vaccine candidate is more than 90 percent effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection.

The results came from the first interim efficacy analysis conducted on Nov. 8 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study of the vaccine BNT162b2, according to a statement of Pfizer.

Analysis evaluated 94 confirmed cases of COVID-19 in trial participants. As the study continues, the final vaccine efficacy percentage may vary, according to the company.

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

The Phase 3 clinical trial 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 Nov. 8, 2020.

The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued, according to Pfizer.

The study also will 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.

In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from 7 days after the second dose, the final analysis now will include new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well, according to Pfizer.