More than 100,000 people have signed up for a clinical trial as the US reaches a historic deal with Pfizer
The US Department of Health and Human Services and the Department of Defense announced an agreement with Pfizer Inc. on Wednesday for “large-scale production and nationwide delivery of 100 million doses of a Covid-19 vaccine in the United States following the vaccine’s successful manufacture and approval,” according to a press release. It also allows the US government to acquire an additional 500 million doses.
The initially produced vaccines will belong to the federal government, and Pfizer will deliver the doses in the United States if the vaccine receives emergency use authorization or licensure from the US Food and Drug Administration.
Remember: Pfizer still needs to complete a large Phase 3 clinical trial.
“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,” Health Secretary Alex Azar said in the release. “Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of vaccine being developed by Pfizer and BioNTech.”
The Biomedical Advanced Research and Development Authority collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command to provide $1.95 billion for the production and nationwide delivery of the first 100 million doses after an OK for the FDA.
How this could play out: If the vaccine is successful and receives EUA or licensure, nationwide delivery would begin in the fourth quarter of 2020.
The doses would be delivered to locations at the US government’s direction and it would be available to Americans at no cost, the release says. Health care professionals could charge insurers for vaccine administration.
“We’ve been committed to making the impossible possible by working tirelessly to develop and produce in record time a safe and effective vaccine to help bring an end to this global health crisis,” Dr. Albert Bourla, Pfizer chair and CEO said in a separate release. “We made the early decision to begin clinical work and large-scale manufacturing at our own risk to ensure that product would be available immediately if our clinical trials prove successful and an Emergency Use Authorization is granted.”
Preliminary data released in a pre-print paper this week by Pfizer and BioNTech said its Covid-19 vaccine appeared safe and elicited antibody and T cell immune responses in a Phase 1/2 trial. More research is needed. The company has said it could start a Phase 3 trial of the vaccine in late July if it receives regulatory approval.
CORRECTION: This post has been updated to indicate that $1.95 billion will be provided for the production and nationwide delivery of the first 100 million doses.
