Pfizer Inc. and BioNTech SE announced Wednesday that the final efficacy analysis of their vaccine candidate, BNT162b2, undergoing the phase 3 trial met all of the study’s primary efficacy endpoints. Biotech companies said the study indicated a 95 percent vaccine efficacy rate, close to the efficacy rate found in early results from Moderna’s candidate vaccine trial.
The phase 3 trial of Pfizer’s candidate vaccine began on July 27, and as of November 13, up to 41,135 volunteers had received their second dose. Pfizer CEO Albert Bourla said in a statement that the results of the study mark an important step on this journey to present a vaccine capable of helping end the pandemic.
“With hundreds of thousands of people around the world infected every day, we urgently need to bring a safe and effective vaccine to the world,” he added.
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Key takeaways from Pfizer’s announcement:
Effectiveness: According to the final analysis, efficacy has remained constant by age, gender, race, and ethnicity. The efficacy observed in people older than 65 years was greater than 94%.
Safety: The Study Data Monitoring Committee has not reported any serious safety concerns related to the vaccine. The firms highlighted that the trial results have reached the safety data milestone required by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) and plan to submit an authorization request. in a few days.
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Storage: The Pfizer candidate vaccine needs ultra-cold storage at around minus 75 ° C and can be stored in the refrigerator for five days. Companies have reportedly developed temperature-controlled thermal conveyors that use dry ice to maintain temperature conditions from -60 ° C to -80 ° C. These chargers can be used as temporary storage units for 15 days by filling with dry ice. .
Production: Companies expect to produce up to 50 million doses of vaccines globally in 2020 and up to 1.3 billion doses by the end of 2021.
Technology: BNT162b2 is an mRNA-based Covid-19 vaccine candidate, the same technology used by Moderna to create its mRNA-1273 vaccine candidate.
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