Pfizer Inc. and BioNTech SE on Wednesday announced that the final efficacy analysis of its vaccine candidate, BNT162b2, undergoing Phase 3 trial met all of the study’s primary efficacy endpoints. The biotech firms said that the study indicated a vaccine efficacy rate of 95 per cent, close to the efficacy rate found in early trial results of Moderna’s vaccine candidate.
The Phase 3 trial of Pfizer’s vaccine candidate began on July 27 and as of November 13, as many as 41,135 volunteers have received its second dose. Pfizer CEO Albert Bourla said in a statement that the study results mark an important step in this journey to bring forward a vaccine capable of helping to end the pandemic.
“With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world,” he added.
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Key takeaways from Pfizer’s announcement:
Efficacy: As per the final analysis, the efficacy has remained consistent across age, gender, race and ethnicity demographics. The observed efficacy in individuals over the age of 65 years was over 94 per cent.
Safety: The Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. The firms highlighted that the trial results have achieved the safety data milestone required by the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) and they plan to submit a request for authorisation within days.
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Storage: Pfizer’s vaccine candidate needs ultra-cold storage at around minus 75°C and can be kept in the fridge for five days. The companies have reportedly developed temperature-controlled thermal shippers that utilise dry ice to maintain temperature conditions of -60°C to -80°C. Such shippers can be used be as temporary storage units for 15 days by refilling with dry ice.
Production: The companies expect to produce up to 50 million vaccine doses 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 come up with its mRNA-1273 vaccine candidate.