Pfizer and its partner BioNTech today asked the U.S. Food and Drug Administration to allow emergency use of the companies’ new COVID-19 vaccine, which they say has been shown to be safe and 95% effective against the coronavirus in their clinical studies.
The FDA process is expected to take a few weeks, and an advisory committee meeting to review the vaccine is tentatively scheduled for early December. This means the vaccine could potentially be available on a limited basis to high-risk people in the U.S. by the middle to end of December.
If approved, the vaccine would be rolled out in phases, with healthcare workers, the elderly and people with underlying health conditions getting the first inoculations. Essential workers, teachers and people in homeless shelters and prisons would likely be next, followed by children and young adults.
“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,” said Albert Bourla, Pfizer chairman and CEO.
Pfizer and BioNTech said they have already initiated rolling submissions with several regulatory agencies around the world, including in Australia, Canada, Europe, Japan and the U.K., and plan to submit applications immediately to other regulatory agencies around the globe.
“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,” said Uğur Şahin, CEO and co-founder of BioNTech.
Pfizer and BioNTech’s combined manufacturing network have the potential to supply up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021, the companies said.