HHS Signs $1.95B Agreement to Produce Pfizer’s COVID-19 Vaccine

HHS and the Department of Defense (DoD) recently announced an agreement with Pfizer Inc. for large-scale production and nationwide delivery of 100 million doses of its COVID-19 vaccine in the US.

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Pfizer and German biotechnology company, BioNTech, jointly developed the COVID-19 vaccine candidate, BNT162, through their mRNA vaccine program.

Under the agreement, the government will pay Pfizer and BioNTech $1.95 billion upon the receipt of the first 100 million doses. 

The delivery will take place following the vaccine’s successful manufacture and approval. 

Under the terms of agreement, the US government can acquire an additional 500 million doses for Americans.

Pfizer will deliver doses in the US if the vaccine receives Emergency Use Authorization (EUA) or licensure from FDA, after showing safety and efficiency in a 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,” said HHS Secretary Alex Azar. 

“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 funding will come from the Biomedical Advanced Research and Development Authority (BARDA) as well astheDoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command, HHS said.

“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,”  Albert Bourla, MD, Pfizer chairman and CEO, said in a statement.

“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. We are honored to be a part of this effort to provide Americans access to protection from this deadly virus.”

Americans will receive the vaccine for free consistent with US government’s commitment to free access for COVID-19 vaccines.

And the agreement furthers the US government’s Operation Warp Speed goal to begin delivering 300 million doses of a promising vaccine to Americans by the end of 2020.

Operation Warp Speed is a public-private partnership to facilitate the development, manufacturing, and distribution of COVID-19 countermeasures, including vaccines, therapeutics, and diagnostics between components of HHS.

Congress has directed almost $10 billion to Operation Warp Speed through supplemental funding, including the CARES Act. Lawmakers have also appropriated other flexible funding. 

Currently, Pfizer and BioNTech are continuing to develop COVID-19 investigational vaccines through their mRNA vaccine program. Phase 1/2 clinical trials are underway for the investigational vaccines in the US and Germany.

Although BioNTech is the market authorization holder worldwide and will hold all trademarks for the potential product, both companies noted their commitment to developing novel vaccines with pre-clinical and clinical data at the forefront of all their decision-making.

“We are pleased to have signed this important agreement with the US government to supply the initial 100 million doses upon approval as part of our commitment to address the global health threat,” Ugur Sahin, MD, CEO and co-founder of BioNTech, said in a statement. 

“This agreement is one of many steps towards providing global access to a safe and efficacious vaccines for COVID-19. We are also in advanced discussions with multiple other government bodies and we hope to announce additional supply agreements soon. Our goal remains to bring a safe and effective COVID-19 vaccine to many people around the world, as quickly as we can.”