A collaboration between BioNTech and Pfizer to develop a potential Covid-19 vaccine has witnessed a breakthrough that could change the face of curbing the second wave of the global pandemic.
The two next generation immunotherapy companies today announced 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.
Dr. Albert Bourla, Pfizer Chairman and CEO said the breakthrough news is 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.
“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,” said Bourla.
“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”.
The vaccine in its third phase test stage with a 2-dose schedule indicates a vaccine efficacy rate above 90%, seven days after the second dose.
However the companies said that the vaccine is still under study and authorities recommended that the study continue to collect additional safety and efficacy data as planned.
The data will be discussed with regulatory authorities worldwide but Pfizer and BioNTech also plan to submit data from the full Phase 3 trial for scientific peer-review publication.
“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.
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.
The trials had approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds.
The clinical trial continue through the final analysis, however, the Director-General of the World Health Organization, Dr. Tedros Adhanom Ghebreyesus welcomed and encouraged the companies for their endeavor among others.
“We welcome the encouraging vaccine news from Pfizer & BioNTech Group and salute all scientists, partners around the world who are developing new safe, efficacious tools to beat Covid-19. The world is experiencing unprecedented scientific innovation and collaboration to end the pandemic,” Dr. Tedros Ghebreyesus said on Twitter.
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.
Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech said they are preparing necessary safety and manufacturing data to submit to the Food and Drug Authorities (FDA) to demonstrate the safety and quality of the vaccine product produced.
Based on current projections both companies said they expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.