[ad_1]
Pfizer and BioNTech recently announced that its 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 July 27, 2020 and to date has enrolled 43,661 participants.
Approximately 42% of global participants and 30% of American participants have diverse racial and ethnic backgrounds, and 41% of global participants and 45% of Americans are between 56 and 85 years of age.
The trial included 150 clinical trial sites in the United States, Germany, Turkey, South Africa, Brazil, and Argentina.
Data analysis indicates a 95% vaccine efficacy rate in participants with no prior SARS-CoV-2 infection.
Efficacy was consistent across demographics of age, gender, race, and ethnicity. The efficacy observed in adults over 65 years of age was greater than 94%.
As part of the study, 170 cases of COVID-19 were registered, of which 162 cases of COVID-19 were observed in the placebo group compared to 8 cases in the BNT162b2 group.
10 severe cases of COVID-19 were seen in the trial, nine of which occurred in the placebo group and one in the BNT162b2 vaccinated group.
To date, the study data monitoring committee has not reported any serious vaccine-related safety concerns.
“The results of the study mark an important step in this historic eight-month journey to present a vaccine capable of helping end this devastating pandemic,” said Pfizer President and CEO Albert Bourla.
According to current projections, 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.
One of the greatest achievements of science
Professor Eric Topol said that the creation of this COVID-19 vaccine will go down in history as one of the greatest achievements of scientific and medical research, perhaps the most impressive.
Topol is the founder and director of the Scripps Research Translational Institute and Professor of Molecular Medicine at Scripps Research.
Your sight echoes that of Dr. Jerome Kim, Director General of the International Vaccine Institute.
Kim said the speed with which researchers and drug companies have responded to the coronavirus epidemic is unprecedented.
He said the medical fraternity is used to terms of five years, and seeing something go through human testing in a few months is extraordinary.
To put the COVID-19 vaccine into perspective, the discovery and research phase of a vaccine generally takes two to five years.
The entire process – discovery and research, preclinical trials, clinical development, regulatory review and approval, manufacturing and delivery – can take more than 10 years.
Condensing all phases of vaccine development in 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.
| Development of the COVID-19 vaccine | |
| Date | Milestone |
| Dec 1, 2019 | Documented COVID-19 disease |
| January 10, 2020 | SARS-CoV-2 virus sequence |
| January 15, 2020 | NIH designs mRNA vaccine in collaboration with Moderna |
| March 16, 2020 | Modern phase 1/2 test begins |
| May 2, 2020 | Pfizer / BioNTech Phase 1/2 Trial Begins |
| July 14, 2020 | Modern phase 1/2 essay published in NEJM |
| July 27, 2020 | Moderna and Phizer / BioNTech phase 3 trial begins |
| August 12, 2020 | Pfizer / BioNTech phase 1/2 trial published in Nature |
| October 22, 2020 | Enrollment in both phase 3 trials was completed with more than 74,000 participants |
| November 9, 2020 | Pfizer / BioNTech announced an interim analysis efficiency of more than 90% |
| November 16, 2020 | Moderna announced an interim analysis efficiency of 94.5% |
| November 18, 2020 | Pfizer / BioNTech announced 95% efficacy as final result |
| November 20, 2020 | First Emergency Use Authorization (USA) submitted by Pfizer / BioNTech |
| November 27, 2020 | Vaccine distribution begins on UAL charter flights throughout the United States |
| December 10, 2020 | FDA External Review of Pfizer / BioNTech Emergency Use Authorization (US) |
| December 11, 2020 | Phase 1a vaccination for healthcare professionals begins |
Pfizer’s COVID-19 Vaccine Explained
Now Read: South Africa Could Be Among The Latest Countries To Receive COVID-19 Vaccine – Report
[ad_2]
