Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq: BNTX) report that their mRNA-based vaccine candidate BNT162b2 targeting SARS-CoV-2 evidences strong efficacy against the novel coronavirus in participants without prior evidence of SARS-CoV-2 infection. This recent positive news is based on the first interim efficacy analysis conducted on November 8, 2020 by an external independent Data Monitoring Committee (DMC) from the Phase 3 clinical trial. The recent news showcases that the vaccine was found to be more than 90% effective in preventing COVID-19 in participants without infection to the virus. Although this is an interim analysis and not conclusive, it certainly is welcome news given the onset of the second even more deadly wave of COVID-19. A workable vaccine may now be within reach thanks to this advanced mRNA-based candidate originally developed in Germany and embraced by Amerian-headquartered multinational pharmaceutical giant Pfizer.
The interim analysis evaluated 94 confirmed cases of COVID-19 in trial participants out of the study that has enrolled 45,538 participants, with 42% having diverse backgrounds. The sponsors report thus far no serious safety observations as of yet. The companies will continuously collect additional efficacy and safety data. Pfizer plans on filing a submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) as soon as the required safety milestone is achieved, which is expected to occur in the third week of November. The sponsors will continue the clinical trial through to the final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints.
Pfizer Chairman and CEO Quote
Dr. Albert Bourla reported, “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.” The chief reported that with this news an effective vaccine is closer to the market to combat COVID-19.
This ongoing study (NCT04368728) commented 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 also will 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 prevention against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease.
In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases, accruing from 7 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 support cross-trial learnings and comparisons between these novel vaccine platforms. Pfizer and BioNTech recently updated a version of the study protocol.
Call to Action: Follow the link to this exciting news via the Pfizer press release.