- On Monday, Pfizer and BioNTech announced the results of their first interim analysis
- The vaccine trial, which is currently in Phase 3, showed the vaccine was more than 90% effective
- The pharmaceutical companies hope to submit it to the FDA for Emergency Use Authorization by the end of November.
With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.
Dr. Albert Bourla, Pfizer Chairman and CEO
The global coronavirus cases have continued to rise at an accelerated rate. This past week the world passed the 50 million cases benchmark. The need for a vaccine is therefore greater than ever. Thus, it seems the news about the vaccine could not have come at a better time.
Pfizer and BioNTech Announce Vaccine Trial Results
In late July, the two pharmaceutical companies, Pfizer and BioNTech started phase 3 trials of their COVID-19 vaccine. They enrolled over 45,000 participants with racially and ethnically diverse backgrounds. 38,955 of these volunteers had received the second dose of the vaccine by Sunday. No serious safety concerns have been reported by scientists till now.
The interim analysis looked at the first 94 confirmed COVID-19 cases among the participants who either received a placebo or two doses of the vaccine. The results showed the vaccine efficacy of over 90% at 7 days after the second dose. Furthermore, less than 10% of the participants who had received the vaccine developed an infection.
The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort
Prof. Ugur Sahin, BioNTech co-founder and CEO
The clinical trial is set to continue till its final stage. The goal is to reach 164 confirmed cases of COVID-19, to collect additional safety and efficacy data on the vaccine. Moreover, cases occurring 14 days after the second dose will also be included in the final analysis.
50 Million Doses by the End of 2020
Pfizer’s vaccine employs messenger RNA, or mRNA, technology. The genetic material in mRNA tricks the body into producing non-dangerous bits of the virus’s proteins. The body’s immune system then recognizes these proteins as foreign and starts fighting them. Thus, producing an immune response.
If approved, this will be the first approved vaccine that is based on mRNA technology.
The companies expect to produce 50 million vaccine doses by the end of the year and around 1.3 billion doses in 2021.
At the moment, the team is working on obtaining an Emergency Use Authorization (EUA) from the U.S Food and Drug Administration (FDA). This will require safety data from two months following the second dose of the vaccine. It is estimated that will be available by the third week of November.
Once the data is available, researchers will submit it for peer review and then to government agencies across the world for approval.
Reference:
Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study. (2020, November 09). Retrieved November 11, 2020, from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against
