[ad_1]
* The candidate vaccine was found to be more than 90% effective in preventing COVID-19 in participants with no evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
* Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
* The study recruited 43,538 participants, of whom 42% have diverse backgrounds and no serious safety issues have been observed; Additional safety and efficacy data continues to be collected
* Submission of the Emergency Use Authorization (US) to the US Food and Drug Administration (FDA) planned for shortly after the required safety milestone is reached, which is currently expected to occur in the third week of november
* The clinical trial will continue through final analysis in 164 confirmed cases in order to collect more data and characterize the performance of the candidate vaccine against other study endpoints.
NEW YORK & MAINZ, GERMANY – (BUSINESS WIRE) – Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external and independent Study Data Monitoring Committee (DMC) Phase 3 clinic.
After discussing it with the FDA, the companies recently chose to abandon the interim analysis of 32 cases and perform the first interim analysis on a minimum of 62 cases.
After those discussions were concluded, the evaluable case count reached 94 and the DMC conducted its first analysis on all cases.
The division of cases between the vaccinated individuals and those who received the placebo indicates an efficacy rate of the vaccine greater than 90%, 7 days after the second dose. This means that protection is achieved 28 days after the start of vaccination, which consists of a 2-dose schedule.
As the study continues, the final efficacy percentage of the vaccine may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities around the world.
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides initial evidence of our vaccine’s ability to prevent COVID-19, ”said Dr. Albert Bourla, President and CEO of Pfizer.
“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 approaching overcapacity and economies struggling to reopen.
With today’s news, we are a significant step closer to giving people around the world a much-needed breakthrough in helping to end this global health crisis. We look forward to sharing additional efficacy and safety data generated by thousands of participants in the coming weeks. “
After discussing it with the FDA, the companies recently chose to abandon the interim analysis of 32 cases and conduct the first interim analysis on a minimum of 62 cases. After those discussions were concluded, the evaluable case count reached 94 and the DMC conducted its first analysis on all cases.
The division of cases between the vaccinated individuals and those who received the placebo indicates an efficacy rate of the vaccine greater than 90%, 7 days after the second dose.
This means that protection is achieved 28 days after the start of vaccination, which consists of a 2-dose schedule. As the study continues, the final efficacy percentage of the vaccine may vary.
The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities around the world.
“I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and researchers at study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial effort. Bourla added. “We couldn’t have gotten this far without the tremendous commitment of everyone involved.”
“The first interim analysis of our global phase 3 study provides evidence that a vaccine can effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort, ”said Professor Ugur Sahin, co-founder and CEO of BioNTech.
“When we embarked on this journey 10 months ago, this is what we aspired to achieve. Especially today, as we are all in the middle of a second wave and many of us locked in, we appreciate even more how important this milestone is on our path to ending this pandemic and for all of us to regain a sense of normalcy.
We will continue to collect more data as the trial continues to sign up for a planned final analysis when a total of 164 confirmed COVID-19 cases have accumulated. I would like to thank everyone who has contributed to making 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 candidate vaccine as of November 8, 2020.
Approximately 42% of global participants and 30% of US participants have diverse racial and ethnic backgrounds. The trial continues to enroll and is expected to continue until the final analysis when a total of 164 confirmed COVID-19 cases have accumulated.
The study will also evaluate the potential of the candidate vaccine to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as the vaccine’s prevention against the severe disease COVID-19.
In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accumulated 7 days after the second dose, the final analysis will now include, with FDA approval, new secondary endpoints evaluating efficacy in function of accumulated cases 14 days after the second dose. dose as well.
The companies believe that the addition of these secondary endpoints will help align the data from all COVID-19 vaccine studies and allow for cross-learning and comparisons between these new vaccine platforms. The companies have posted an updated version of the study protocol at https://www.pfizer.com/science/coronavirus.
Pfizer and BioNTech continue to accumulate safety data and currently estimate that a median of two months of safety data after the second (and last) dose of the candidate vaccine, the amount of safety data specified by the FDA in its guidance for a possible emergency use. Authorization: will be available for 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 manufacturing and safety 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 up to 50 million doses of vaccines globally 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 publication by peer review.
[ad_2]
