If drugmaker Pfizer and its European partner, BioNTech, get emergency approval from the U.S. Food and Drug Administration (FDA) for their COVID-19 vaccine candidate, they’ll be able to start shipping doses “within hours.”
That’s according to the companies, who submitted an application to the FDA on Friday.
They’ve also started the application process for expedited approval in places like Canada, Australia, Europe, Japan and the U.K.
If approved, Pfizer and BioNTech say they expect to produce up to 50-million doses by the end of the year and up to 1.3-billion doses in 2021.
Earlier this month, Pfizer announced that its vaccine candidate is 95 per cent effective, with no serious safety concerns reported.
Some high-risk groups and vulnerable people could start getting the vaccine in the U.S. by the middle or end of December.
According to the companies, the vaccine is highly effective in people who have already had COVID-19 and those who have never had it.
Thousands of people have already received the vaccine during clinical trials, including kids under 15-years-old and ‘high-risk’ adults between 56 and 85.
Most of the people who already got immunized have been under observation for weeks or months.
“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,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “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.”
If approved by Health Canada, the federal government has agreed to buy millions of doses for distribution across the country.
Photo courtesy of Pfizer