Pfizer submitted an application for an emergency use authorization of its COVID-19 vaccine candidate to the FDA Nov. 20.
If approved, Pfizer said it would be ready to distribute the vaccine within hours of authorization, which could allow the first Americans to be vaccinated by mid-December. It's not clear how long the FDA will take to review the application.
Pfizer said it plans to produce up to 50 million vaccine doses this year and up to 1.3 billion by the end of 2021.
The drugmaker, along with its German partner, BioNTech, have also submitted applications for approval to Australia, Canada, Europe, Japan and the U.K. and plan to submit applications to other regulatory agencies around the world immediately.
"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 Pfizer CEO Albert Bourla, PhD.
Pfizer said Nov. 18 that its COVID-19 vaccine is 95 percent effective, and its data-monitoring committee has found no serious safety concerns.
The drugmaker said it has established cold-chain infrastructure to supply the vaccine worldwide. It has to be stored at temperatures about minus-90 degrees Fahrenheit, and Pfizer has designed a temperature-controlled shipping box that can maintain the temperature for up to 15 days. Each box has a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment.
Pfizer has also created distribution hubs that can store the vaccine doses for up to six months. Once thawed, the vaccine can be stored in a refrigerator for up to five days.
Read Pfizer's full news release here.