Pfizer and BioNTech say vaccine effective, no safety concerns

A final efficacy analysis of the Pfizer and BioNTech novel coronavirus (COVID-19) vaccine found it is 95 percent effective in preventing infections across patient populations with no serious safety concerns, according to an announcement made earlier today.  

Additionally, the companies said they plan to submit a request within days to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). The data will also be submitted to other regulatory agencies around the world.

The analysis of the Phase 3 clinical trial of the mRNA-based vaccine candidate, BNT162b2, found a vaccine efficacy rate of 95 percent in participants without prior SARS-CoV-2 infection as well as  participants with and without prior SARS-CoV-2 infection in each case measured from seven days after the second dose, according to the announcement.

The first primary objective analysis was based on 170 cases of COVID-19, of which 162 cases of COVID-19 were observed in the placebo group versus eight cases in the BNT162b2 group. Efficacy was consistent across age, gender, race, and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94 percent, the companies said. There were 10 severe cases of COVID-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group.

To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine, according to the announcement.

The news follows an announcement made by competitor Moderna earlier this week, which said its COVID-19 vaccine appears to be 94.5 percent effective. A final data analysis is in progress.  

 In an earlier analysis, Pfizer previously said its vaccine was more than 90 percent effective. The new data confirms these results.

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