Pharmaceutical giant Pfizer Inc. (PFE) and German biotech firm BioNTech SE (BNTX) said Wednesday that final data analysis from the Phase 3 study of their coronavirus vaccine candidate, BNT162b2, showed the vaccine to be 95 percent effective in preventing COVID-19. Shares of Pfizer rose more than 4 percent in the pre-market trade following the news.
The mRNA-based vaccine candidate also showed effectiveness of more than 94 percent in adults over 65 years of age, who are more at risk of dying from the coronavirus. In addition, the vaccine met all of the study’s primary efficacy endpoints.
Both the companies said they plan to submit for emergency use authorization or EUA “within days” to the FDA. The data from the study also will be submitted to other regulatory agencies around the world.
The news comes more than a week after Pfizer and BioNTech said the interim efficacy analysis showed that the vaccine was more than 90 percent effective in preventing COVID-19.
More promising vaccine results are hitting the headlines these days.
Monday, Moderna Inc. also said that preliminary data from the Phase 3 study of its coronavirus vaccine candidate, mRNA-1273, showed the vaccine to be more than 94 percent effective.
The late-stage clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date. Of the total participants, 41,135 have received a second dose of the vaccine candidate as of November 13, 2020.
The final analysis evaluated 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group.
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.
The vaccine’s effectiveness was consistent across all age, gender, race and ethnicity demographics.
Pfizer and BioNTech said 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 by the end of 2021.
The companies also said they have developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of -70C to 10C. They can be used be as temporary storage units for 15 days by refilling with dry ice.
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