Pharmaceutical, Pfizer Inc announces COVID-19 Vaccine with 90% efficacy
American multinational pharmaceutical company Pfizer Inc. and Germany’s BioNTech SE have today announced their mRNA-based vaccine candidate, BNT162b2, against COVID-19 and has produced 90% evidence of efficacy judging by the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical trials.
Describing it as a great day to science and humanity, Dr. Albert Bourla, Pfizer Chairman and CEO said they have held discussion with the FDA whose approvals provisions it had surpassed requiring that placebo-controlled trials have an efficacy of at least 50 percent, which according to the World Health Organization is just excellent considering no vaccine can be 100 percent effective. The vaccinated individuals and those who received the placebo indicate the vaccine efficacy rate was above 90%, at 7 days after the second dose, thus means the protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity, and economies struggling to reopen. 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.”
The Phase 3 clinical trial of BNT162b2 which began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020. Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. The study will also evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease.
The drug will be submitted to authorities, the FDA under its guidance for potential Emergency Use Authorization for emergency approval in the third week of November. Pfizer and BioNTech are continuing to accumulate safety data and working to demonstrate the safety and quality of the vaccine product produced that is projected to serve up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021, globally.
Chief Executive Officer, BIO, Ugur Sahin said BioNTech and Pfizer would “use a fair approach” when distributing the first doses of the vaccine, adding that they would prioritize deliveries to countries where it had been approved for use.