The U.S. government will pay Pfizer and BioNTech $1.95 billion upon the receipt of the first 100 million doses, following US Food and Drug Administration (FDA) authorization or approval. The U.S. government also can acquire up to an additional 500 million doses.
The US government announced this morning it is going to buy the Pfizer and BioNTech
The U.S. government will pay the companies $1.95 billion upon the receipt of the first 100 million doses, following US Food and Drug Administration (FDA) authorization or approval. The U.S. government also can acquire up to an additional 500 million doses.
“Expanding Operation Warp Speed’s diverse portfolio by adding a vaccine from Pfizer and BioNTech increases the odds that we will have a safe, effective vaccine as soon as the end of this year,” HHS Secretary Alex Azar said. “Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of this vaccine to the American people.”
Just last week the FDA
“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,” Pfizer Chairman and CEO Albert Bourla said.
“We are honored to be a part of this effort to provide Americans access to protection from this deadly virus.”
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The development shows just how fast the process of finding a COVID-19 vaccine is moving under the government’s Project Lightspeed vaccine approval program. Officials of the 2 companies said last week that they planned to take the FDA’s approval and run with it.
“The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” Peter Honig, senior vice president, Global Regulatory Affairs, Pfizer, said last week. “We look forward to continue working closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”
Project Lightspeed is based on BioNTech’s proprietary mRNA-based technology platforms and supported by Pfizer’s global vaccine development capabilities. The vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world.
“We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward,” Chief Medical Officer Özlem Türeci at BioNTech reiterated.
As this is breaking news, stay tuned for future developments.
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