The US Department of Health and Human Services and the Department of Defense on Wednesday announced an agreement with Pfizer Inc. for the mass production and nationwide distribution of 100 million doses of the Kovid-19 vaccine in the United States. And approval, according to a press release. “It also allows the US government to receive an additional 500 million doses.
The vaccines initially produced will belong to the federal government, and if the vaccine obtains an Emergency Use Authority or license from the Food and Drug Administration of the US, Pfizer will distribute the dose to the United States.
remember: Pfizer is still required to complete a large phase 3 clinical trial.
“Through Operation War Speed, we are assembling a portfolio of vaccines to raise at least one safe, effective vaccine for the American people by the end of this year,” said Health Secretary Alex Azar. “Based on the success in clinical trials, today’s agreement will enable delivery of approximately 100 million doses being developed by Pfizer and BioNotech.”
The Biomedical Advanced Research and Development Authority teamed up with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command to provide $ 100 million after OK for FDA and $ 1.95 billion for nationwide delivery . .
How it can play: If the vaccine is successful and obtains a European Union or license, nationwide distribution will begin in the fourth quarter of 2020.
The release stated that the dose would be delivered to the locations on the direction of the US government and would be available to Americans. Health care professionals may charge insurers for vaccine administration.
“We are committed to making the impossible possible by working tirelessly to develop and produce a safe and effective vaccine in record time to help end this global health crisis,” Dr. Albert Borla, Pfizer chair and CEO Said separate release. “We made the initial decision to begin clinical work and large-scale manufacturing at our own risk to ensure that the product would be available immediately if our clinical trials proved successful and an emergency use authority was granted.”
Preliminary data released this week in a pre-print paper by Pfizer and BioNTech stated that its Kovid-19 vaccine reveals safe and elicited antibodies and T cell immune responses in the Phase 1/2 trial. More research is needed. The company said it could begin Phase 3 trials of the vaccine in late July if it gets regulatory approval.
Correction: This post has been updated to indicate that $ 1.95 billion will be provided for the first 100 million dose production and nationwide distribution.