Up to 600 million doses of a vaccine candidate produced by Pfizer Inc. and BioNTech could be acquired by the United States government under a deal penned this week.
All of this would be conditional on the vaccine’s successful manufacture and either Emergency Use Authorization or licensure approval from the U.S. Food and Drug Administration (FDA), but as of now, the U.S. has committed to production and delivery of 100 million doses of the candidate, BNT162. To reach such approvals, the drug would have to demonstrate its safety and efficacy in a large phase 3 clinical trial.
The U.S. government will pay $1.95 billion upon the receipt of the first 100 million doses. After that, the U.S. government can acquire up to an additional 500 million doses.
“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,” Dr. Albert Bourla, Pfizer Chairman and CEO, said. “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.”
BNT162 is actually a program currently consisting of at least four experimental vaccine candidates. Each utilizes mRNA format.
So far, Pfizer and BioNTech have worked to develop the vaccine without U.S. government support. Phase 1/2 clinical trials are underway in both the U.S. and Germany, and preliminary data has been promising. A global phase 2b/3 trial for safety and efficacy should begin later this month.
“This agreement is one of many steps towards providing global access to a safe and efficacious vaccines for COVID-19,” Dr. Ugur Sahin, CEO and co-founder of BioNTech, said. “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.”
The two companies reached a separate agreement with the U.K. earlier this week for 30 million doses of the BNT162 vaccine.
“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,” HHS Secretary Alex Azar said. “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.”
If all goes well, delivery of those doses could begin in the fourth quarter of this year. According to HHS, the vaccine would be provided to Americans at no cost, though healthcare professionals could still charge insurers for the cost of administering it.