The USA Orders 100 Million Coronavirus Vaccine Doses for $1.95 Billion

Pfizer and BioNTech anticipate launching Phase 2b/3 safety and efficacy trial during the 2020 summer
100 $ bills in a lock box

The U.S. government is reported to have placed an initial order of 100 million vaccine doses for $1.95 billion of the SARS-CoV-2 virus preventive vaccine, BNT162.

Additionally, the government also can acquire up to an additional 500 million doses.

The BNT162 vaccine candidate(s) are undergoing clinical studies and are not currently approved for distribution anywhere in the world. BioNTech is the market authorization holder worldwide and will hold all trademarks for the potential product.

This vaccine development program is evaluating at least 4 experimental vaccines, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen.

According to a press statement issued by Pfizer Inc. and BioNTech SE on July 22, 2020, Americans will be able to receive the vaccine for free.

“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,” said Dr. Albert Bourla, Pfizer Chairman and CEO, in a press release. 

“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.”

“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,” said HHS Secretary Alex Azar.

“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.”

“We are pleased to have signed this important agreement with the U.S. government to supply the initial 100 million doses upon approval as part of our commitment to address the global health threat.”

“Our goal remains to bring a safe and effective COVID-19 vaccine to many people around the world, as quickly as we can,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

Previously, Pfizer and BioNTech announced on July 1, 2020, preliminary data from BNT162b1, the most advanced of the four mRNA formulations. The early data demonstrate 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. 

Furthermore, no serious adverse events were reported. 

And on July 20th, the companies announced an early positive update from the German Phase 1/2 COVID-19 vaccine study, including first T Cell response data.

Further data from the ongoing Phase 1/2 clinical trials of the four vaccine candidates will enable the selection of a lead candidate and dose level for an anticipated large, global Phase 2b/3 safety and efficacy study that may begin as early as later this month, pending regulatory approval.

If the ongoing studies are successful, Pfizer and BioNTech expect to be ready to seek U.S. FDA Emergency Use Authorization or some form of regulatory approval as early as October 2020. 

The companies currently expect to manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021, subject to final dose selection from their clinical trial.

Precision Vaccinations publishes COVID-19 vaccine development news.