"Every jurisdiction will have access immediately upon the initial push of the vaccine," Gen. Gustave Perna, chief operating officer of the Trump administration's Operation Warp Speed, said during a call with reporters.
“Today, we expect to have tens of millions of doses immediately following emergency use authorization (EUA), and we will distribute them as soon as the FDA applies the EUA. We will do that within 24 hours of the EUA,” Perna said.
Perna told reporters, “What is Operation Warp Speed about? It is about saving lives, and it is a herculean task that the President put us on many months ago. And as Dr. Slaoui just laid out, we are making steady progress and we are ready to execute.”
Perna continued, “Six months ago, the capacity did not exist in our nation’s pharmaceutical production base. We went to work building brick and mortar manufacturing facilities, bringing in the right specialized machinery, and prioritizing supply-chain materials through the Defense Production Act.”
New York-based Pfizer and Germany-based BioNTech said Wednesday that the phase 3 study for their vaccine candidate had concluded after meeting all primary endpoints, and they plan on submitting a request to the Food and Drug Administration (FDA) for a EUA this week.
“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” Dr. Albert Bourla, Pfizer chairman and CEO, said in a statement.
“With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.
“We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose, underscoring the power of BNT162 in providing early protection,” added Dr. Ugur Sahin, CEO, and co-founder of BioNTech.
Perna said getting the vaccine out this fast could only be done because of collaboration between public and private stakeholders.
“It is the partnerships we have formed with the pharmaceutical companies like Pfizer and Moderna; distribution companies like McKesson, FedEx, and UPS; and pharmacies like CVS and Walgreens that have agreed to do things differently.”