In the latest development in Operation Warp Speed, The Department of Health and Human Services and the Department of Defense have ordered 100 million doses of the novel coronavirus vaccine currently under development by Pfizer, Inc. and German company BioNTech SE for $1.95 billion. The agreement also leaves the door open for the government to purchase an additional 500 million doses. The vaccine candidate is currently in Phase 1 and 2 clinical trials, and Pfizer says it is “on track” to enter Phase 2b and 3 trials later this month.
The order is the latest move by Operation Warp Speed, the government program to secure and distribute vaccine candidates in anticipation of a rapid deployment once the vaccine candidates in question are authorized. The program has also placed orders with Novavax, Inc., AstraZeneca PLC, and Moderna, Inc.
“Through operation Warp Speed, we are assembling a portfolio of vaccines to increase the odds that the American people will have at least one safe, effective vaccine as soon as the end of this year,” said Health and Human Services Secretary Alex Azar. The program’s stated goal is to deliver 300 million doses of an authorized, safe, and effective vaccine for the virus by the end of the year.
If that timeline is realized, it would represent an unparalleled turnaround from discovery of a novel virus to deployment of a vaccine to combat it. Even previous estimates that such an authorization could come as soon as January 2020, 12 months after the virus’ genetic sequence was distributed to researchers worldwide, would be faster than previous vaccine developments by a matter of years. In a statement, Pfizer said that if current studies are successful, they might be ready to seek Emergency Use Authorization “or some form of regulatory approval as early as October 2020.”
“We are honored to be a part of this effort to provide Americans access to protection from this deadly virus,” said Dr. Albert Bourla, Pfizer CEO. BioNTech CEO Ugur Sahin, M.D., said his company’s goal “remains to bring a safe and effective COVID-19 vaccine to many people around the world, as quickly as we can.”