HHS is securing Pfizer and BioNTech’s BNT162 vaccine as soon as FDA approves.
The US government announced this morning it is going to buy the Pfizer and BioNTech coronavirus (COVID-19) vaccine.
The US government will pay the companies $1.95 billion upon the receipt of the first 100 million doses of BNT162, following US Food and Drug Administration (FDA) authorization or approval. The US can also 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,” Health and Human Services 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 fast tracked 2 of the companies' COVID-19 vaccines. The BNT162b1 and BNT162b2 are the investigational vaccines that were given the go-ahead.
“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.”
This is a joint research venture between the biopharmaceutical companies. The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities.
The Pfizer/BioNTech vaccine development program is evaluating at least four experimental vaccines, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen. On July 1, Pfizer and BioNTech announced preliminary data from BNT162b1, the most advanced of the four mRNA formulations.
The early data demonstrates that BNT162b1 is able to produce neutralizing antibodies in humans at or above the levels observed in the plasma from patients who have recovered from COVID-19, and this was shown at relatively low dose levels.
Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. No serious adverse events were reported. On July 20, the companies announced early positive update from a German Phase 1/2 COVID-19 vaccine study, including first T Cell response data.
This news follows the UK’s decision to buy the two companies’ vaccine earlier this week.