Story at a glance
- Drug manufacturer Pfizer will submit its COVID-19 vaccine candidate for Emergency Use Authorization approval today.
- This follows Moderna’s announcement, similarly touting an effective vaccine.
Following last week’s optimistic announcement of vaccine data showcasing a 90, and later 95, percent efficacy rate, Pfizer will be seeking an Emergency Use Authorization (EUA) for its COVID-19 vaccine candidate.
In a press release, company officials confirmed that the pharmaceutical titan will submit its EUA request to the U.S. Food and Drug Administration (FDA) on Friday.
The vaccine, called BNT162b2, is composed of messenger RNA, a key molecule in cellular protein synthesis. It was manufactured through a partnership between Pfizer and German company BioNTech.
Officials also note that Pfizer and BioNTech’s joint inducted network can help supplies reach to about 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021.
Initial doses of the vaccine will ideally go toward high-risk populations, including frontline workers and elderly people, by the middle to end of December.
“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 Albert Bourla, the 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.”
The company had also submitted a similar EUA request to other regulatory bodies similar to the Centers for Disease Control and Prevention in other countries.
Contemporary company Moderna also delivered comparable news, presenting a 94.5 percent efficacy rate for its vaccine candidate.
Notably, BNT162b2 must be stored and transported at cold temperatures, leading to pharmaceutical companies launching a pilot test delivery of the vaccine to four states in the U.S.
“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,” said Ugur Sahin, CEO and co-founder of BioNTech. “We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally.”