By Audrey Lotechukwu
MON, 09 NOV, 2020-theGBJournal- Pfizer is on track later this month to file an emergency use application with U.S. regulators following positive efficacy results from the Phase 3, late-stage study of the potential COVID-19 vaccine candidate.’’
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.’’
Pfizer shared the news Monday, saying that the vaccine candidate developed with collaborator BioNTech, was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.
‘’The results demonstrate that our mRNA-based vaccine can help prevent COVID-19 in the majority of people who receive it. This means we are one step closer to potentially providing people around the world with a much-needed breakthrough to help bring an end to this global pandemic.’’
This is a first but critical step in our work to deliver a safe and effective vaccine.
Pfizer estimates that a median of two months of safety data following the second and final dose of the vaccine candidate – required by FDA’s guidance for potential Emergency Use Authorization – will be available by the third week of November.
‘’We are also generating data to show that our vaccine can be consistently manufactured to meet quality standards.
Efficacy, safety and consistent manufacturing are the three requirements that are needed before we are able to file for authorization.’’
“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” said Prof. Ugur Sahin, BioNTech co-founder and CEO. “When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.”
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. 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 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 allow for cross-trial learnings and comparisons between these novel vaccine platforms.
Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate – the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization – will be available by the third week of November.
Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
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.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.
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