Pfizer/BioNTech Covid Vaccine 90% Effective Vaccine: Early Data
Pfizer and BioNTech have reported data from an interim efficacy analysis showing that its Covid-19 vaccine is more than 90% effective in preventing the virus based on the evaluation of 94 Covid cases in participants. Pfizer says an emergency use authorization submission could be completed later this month, which will then trigger an FDA an advisory committee meeting to review data and make recommendations on the vaccine’s availability.
The Phase 3 clinical trial of BNT162b2 began on 7/7 and has enrolled 43,538 participants to date. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed cases will have accrued. The study is also evaluating the potential for the vaccine to provide protection in those who have had prior exposure to the virus, as well as protection from severe forms of Covid-19 disease, the companies say. They add that that the analysis shows that protection is achieved 28 days after two doses of the vaccine. Their data monitoring committee did not report any serious safety concerns and recommended that the study continue to collect additional safety and efficacy data as planned.
In reaction, National Institute of Allergy and Infectious Diseases director Anthony Fauci said the results suggesting 90% effectiveness are “just extraordinary,” adding: “It’s going to have a major impact on everything we do with respect to Covid.”
A Pfizer statement says that “In addition to the primary efficacy endpoints evaluating confirmed Covid-19 cases accruing from seven days after the second dose, the final analysis now will include, with the approval of the FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well. The companies believe that the addition of these secondary endpoints will help align data across all COVID-19 vaccine studies and allow for cross-trial learnings and comparisons between these novel vaccine platforms. The companies have posted an updated version of the study protocol at https://www.pfizer.com/science/coronavirus.”
Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech say they are preparing the required safety and manufacturing data to submit to FDA. “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,” they add.