Pfizer Inc and German partner BioNTech Monday said its experimental Covid-19 vaccine has been found to be 90% effective.
They are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine with no serious safety concerns being found.
The Phase 3 clinical trial of BNT162b2 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.
“We’re in a position potentially to be able to offer some hope,” Dr. Bill Gruber, Pfizer’s senior vice president of clinical development, told The Associated Press. “We’re very encouraged.”
“Today is a great day for science and humanity,” Albert Bourla, Pfizer’s chairman and chief executive, said.
“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.”
Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.
“Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.”
What is Vaccine efficacy?
According to Dr. Nelly Yatich, an Epidemiologist, Vaccine efficacy (VE) is measured by calculating the risk of disease among vaccinated and unvaccinated persons, and determining the % reduction in risk of disease among vaccinated persons relative to unvaccinated persons.
The > the % reduction of illness in the vaccinated group, the > the vaccine efficacy. So here, a VE of 90% indicates a 90% reduction in disease occurrence among the vaccinated group or a 90% reduction from the number of cases you would expect if they have not been vaccinated.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.
UPDATE: We are proud to announce, along with @BioNTech_Group, that our mRNA-based #vaccine candidate has, at an interim analysis, demonstrated initial evidence of efficacy against #COVID19 in participants without prior evidence of SARS-CoV-2 infection.
— Pfizer Inc. (@pfizer) November 9, 2020