Pfizer and BioNTech will seek regulatory clearance of their coronavirus vaccine
Source: Washington Post
Pfizer and its German partner BioNTech announced they plan to file Friday for emergency authorization of their coronavirus vaccine, a landmark moment and a signal that a powerful tool to help control the pandemic could begin to be available by mid- to late December.
The filing is a significant step in the effort to develop a vaccine and will move the race to its next, deliberative phase — a weeks-long process in which career scientists at the Food and Drug Administration scrutinize the data and determine if the vaccine is safe and effective.
Only after the agency has given the green light will a first, limited group of high-risk people be able to access the shots. Government officials anticipate having enough vaccine to inoculate about 20 million people with the two-dose regimen in the U.S. in December, between Pfizer’s vaccine and a second shot likely to be considered for emergency authorization soon, from biotechnology company Moderna. The United States will receive about half of the 50 million doses Pfizer is aiming to produce by the end of the year.
There will probably be enough vaccine for 25 million to 30 million people a month in early 2021, according to Moncef Slaoui, chief scientific adviser of Operation Warp Speed, the federal government initiative to speed up vaccine development. He did not specify how many doses each company would contribute.
Read more: https://www.washingtonpost.com/health/2020/11/20/covid-pfizer-vaccine/