The US Department of Health and Human Services and the Department of Defense announced an agreement with Pfizer Inc. on Wednesday for “the large-scale production and nationwide delivery of 100 million doses of a Covid-19 vaccine in the United States after the successful manufacture of the vaccine. ” and approval, “according to a press release. It also allows the United States government to purchase an additional 500 million doses.
Initially produced vaccines will belong to the federal government, and Pfizer will administer the doses in the United States if the vaccine receives authorization or license for emergency use from the United States Food and Drug Administration.
Remember: Pfizer still needs to complete a large phase 3 clinical trial.
“Through Operation Warp Speed, we are putting together a portfolio of vaccines to increase the likelihood that the American people will have at least one safe and effective vaccine as soon as this year ends,” said Health Secretary Alex Azar in the notice. “Depending on the success of clinical trials, today’s agreement will allow the delivery of approximately 100 million doses of vaccine developed by Pfizer and BioNTech.”
The Advanced Biomedical Research and Development Authority collaborated with the Executive Office of the Joint DoD Program for the Army Recruitment Command and Chemical, Biological, Radiological and Nuclear Defense to provide $ 1.95 billion for the production and national delivery of the first 100 million doses after a go-ahead for the FDA.
How could this develop: If the vaccine is successful and receives the US or license, nationwide delivery would begin in the fourth quarter of 2020.
The doses would be shipped to locations at the address of the US government and made available to Americans at no cost, according to the statement. Health professionals may charge insurers for administering the vaccine.
“We are committed to doing the impossible possible by working tirelessly to develop and produce in record time a safe and effective vaccine to help end this global health crisis,” said Dr. Albert Bourla, President and CEO of Pfizer at a statement. launch separately. “We made the early 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 are successful and an Emergency Use Authorization is granted.”
Preliminary data published in a preprinted paper this week by Pfizer and BioNTech said their 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 publication has been updated to indicate that $ 1.95 billion will be provided for the national production and delivery of the first 100 million doses.
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