Pfizer Inc on Wednesday said a final analysis of clinical-trial data showed its Covid-19 vaccine was 95% effective, paving the way for the company to apply for the first US regulatory authorization for a coronavirus shot within days. The US drugmaker and partner BioNTech SE said their vaccine protected people of all ages and ethnicities, with no significant safety problems so far in a trial that included almost 44,000 participants.
The study reached 170 confirmed cases of COVID-19, with the vaccine candidate BNT162b2 demonstrating 95 per cent efficacy beginning 28 days after the first dose, Pfizer said. “Additionally, the safety milestone required by the US FDA (Food and Drug Administration) for Emergency Use Authorization (EUA) has been achieved. To date, no serious safety concerns related to the vaccine candidate have been reported,” it said.
“Within days, we plan to submit a request to the US FDA for an EUA based on the totality of safety and efficacy data collected, as well as manufacturing data relating to the quality and consistency of the vaccine candidate,” it added.
Pfizer, BioNTech plan regulatory filing as vaccine proves 95% effective
- Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose; 170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group
- Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94%
- Safety data milestone required by U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved
- Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled; no serious safety concerns observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%
- Companies plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe
- 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
- Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world