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.
Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second and final dose of the vaccine candidate will be available by the third week of November.
The two companies plan to summit for Emergency Use Authorization (EUA) of the vaccine to the U.S. Food and Drug Administration (FDA) after the required safety milestone is achieved.
Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced, according to Pfizer.
The two companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
The vaccine is one of the four COVID vaccine candidates under phase 3 trials in the United States. The other three vaccines are from Moderna, AstraZeneca and Johnson &Johnson.
Confirmed COVID-19 cases in the United States surpassed 10 million on Monday and daily infections have surged more than 60 percent over two weeks, according to data of Johns Hopkins University.
