Pfizer and BioNTech recently announced that their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints.
The Phase 3 clinical trial of BNT162b2 began on 27 July 2020 and has enrolled 43,661 participants to date.
Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56 to 85 years of age.
The trial included 150 clinical trials sites in United States, Germany, Turkey, South Africa, Brazil, and Argentina.
Analysis of the data indicates a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection.
Efficacy was consistent across age, gender, race, and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%.
As part of the study 170 cases of COVID-19 were recorded 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.
To date, the data monitoring committee for the study has not reported any serious safety concerns related to the vaccine.
“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” said Pfizer Chairman and CEO Albert Bourla.
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.
One of science’s greatest achievements
Professor Eric Topol said the creation of this COVID-19 vaccine will go down in history as one of science and medical research’s greatest achievements – perhaps the most impressive.
Topol is the founder and director of the Scripps Research Translational Institute and Professor of Molecular Medicine of Scripps Research.
His view echoes that of Dr Jerome Kim, Director-General of the International Vaccine Institute.
Kim said the speed with which researchers and pharmaceutical companies have responded to the coronavirus epidemic is unprecedented.
He said the medical fraternity is used to five-year time frames, and to see something go into human testing within months is remarkable.
To put the COVID-19 vaccine into perspective, the discovery and research phase for a vaccine usually takes two to five years.
The full process – discovery and research, pre-clinical trials, clinical development, regulatory review and approval, and manufacturing and delivery – can take more than 10 years.
To condense all the vaccine development phases into less than a year is nothing short of astonishing.
Topol provided a timeline of key milestones to show how several years of work were compressed into months.
|COVID-19 Vaccine Development|
|1 December 2019||COVID-19 illness documented|
|10 January 2020||SARS-CoV-2 virus sequenced|
|15 January 2020||NIH designs mRNA vaccine in collaboration with Moderna|
|16 March 2020||Moderna phase 1/2 trial begins|
|2 May 2020||Pfizer/BioNTech phase 1/2 trial begins|
|14 July 2020||Moderna phase 1/2 trial published in NEJM|
|27 July 2020||Moderna and Phizer/BioNTech phase 3 trial begins|
|12 August 2020||Pfizer/BioNTech phase 1/2 trial published in Nature|
|22 October 2020||Enrollment in both phase 3 trials complete with over 74,000 participants|
|9 November 2020||Pfizer/BioNTech announced interim analysis efficacy of over 90%|
|16 November 2020||Moderna announced interim analysis efficacy of 94.5%|
|18 November 2020||Pfizer/BioNTech announced 95% efficacy as final result|
|20 November 2020||First Emergency Use Authorization (EUA) submitted by Pfizer/BioNTech|
|27 November 2020||Distribution of vaccine by UAL charter flights begin throughout the United States|
|10 December 2020||FDA external review of Pfizer/BioNTech Emergency Use Authorization (EUA)|
|11 December 2020||Phase 1a vaccination begins for healthcare professionals|