The companies have already begun rolling submissions across the globe including in Australia, Canada, Europe, Japan and the UK
Pfizer and BioNTech to seek FDA EUA for BNT162b2. (Credit: Pete Linforth from Pixabay.)
Pfizer and BioNTech have filed an application with the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA-based Covid-19 vaccine candidate BNT162b2.
The regulatory submission is aimed at enabling the use of SARS-CoV-2 vaccine in high-risk populations in the US by the end of December 2020.
Pfizer and BioNTech have already started rolling submissions with global regulatory agencies, including the EMA and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK.
The companies have already begun rolling submissions across the globe including in Australia, Canada, Europe, Japan and the UK.
Pfizer chairman and CEO Albert Bourla said: “Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of Covid-19 globally.
“Filing in the U.S. represents a critical milestone in our journey to deliver a Covid-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential.
“We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”
Pfizer and BioNTech’s regulatory submission for BNT162b2 is based on a Phase 3 clinical study, which demonstrated a 95% vaccine efficacy rate in 43,661 participants, measured after seven days from the administration of the second dose.
The submission was also supported by solicited safety data from a randomised subset of nearly 8,000 participants, aged 18 years or above, and unsolicited safety data from around 38,000 trial participants two months after the second dose of the vaccine.
BNT162b2 has not resulted in any serious safety concerns in Phase 3 clinical trial, as reported by the individual Data Monitoring Committee (DMC) for the study.
The companies noted that their vaccine candidate is not currently approved for global distribution, and is being studied in preclinical and clinical data.
BioNTech CEO and Co-founder Ugur Sahin said: “Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible.
“We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally. As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process.”