The U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) have ordered an initial 100 million doses the COVID-19 vaccine being developed by Pfizer and BioNTech for $1.95 billion, the companies said today—with the option to purchase 500 million additional doses.

The companies agreed to offer BNT162 for free under an agreement signed as part of Operation Warp Speed—the program through which President Donald Trump’s administration has committed the nation to delivering 300 million vaccine doses protecting against SARS-CoV-2 by January 2021. The program funds and coordinates development of vaccines, drugs, and diagnostics across agencies of DoD and HHS—the latter agency including the FDA, the NIH, the Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA).

“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 II said in a statement.

The companies did not announce the price Washington would pay for the additional 500 million doses should they be ordered—but did say the agreement is subject to Pfizer successfully manufacturing and obtaining approval or emergency use authorization for the vaccine. Pfizer and BioNTech said they expect to be ready to seek emergency use authorization or some form of regulatory approval as early as October.

Pfizer and BioNTech 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 trials.

The companies have agreed to carry out clinical development and manufacturing of BNT162 at their 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, DVM, PhD, stated.

The Operation Warp Speed award reverses what had been the companies’ reluctance until now to tap into U.S. government funding: “We believe we can move faster if we don’t have to involve a third party,” Bourla said May 28 at during a virtual briefing organized by International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

“Making the impossible possible”

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

BNT162 is one of 18 “Front Runner” programs among more than 270 COVID-19 therapeutics included in GEN’s updated “COVID-19 DRUG & VACCINE CANDIDATE TRACKER.”

Pfizer and BioNTech are studying four constructs of BNT162: Two nucleoside modified mRNA (modRNA) candidates (BNT162b1 and BNT162b2); a uridine containing mRNA (uRNA) candidate; and a candidate using self-amplifying mRNA (saRNA).

The two most advanced of the four constructs are BNT162b1, which encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen, and  BNT162b2, which encodes an optimized SARS-CoV-2 full-length spike protein antigen. Both constructs were granted the FDA’s Fast Track designation earlier this month.

The most advanced construct of BNT162—BNT162b1—was the subject of a preprint study published in medRxiv on Monday that showed BNT162b1 to have elicited high, dose level-dependent SARS-CoV-2-neutralizing titers and receptor binding domain (RBD)-binding immunoglobulin G (IgG) concentrations after the second dose. The data emerged from an ongoing German Phase I/II, open-label, non-randomized, non-placebo-controlled, dose-escalation trial (EU Clinical Trials Registry EudraCT number 2020-001038-36).

On July 1, Pfizer and BioNTech said BNT162b1 showed encouraging immunogenicity and a favorable safety profile in preliminary Phase I/II data from an ongoing U.S. Phase I/II trial (NCT04368728), a randomized, placebo-controlled, observer-blinded study designed to assess the safety, tolerability, and immunogenicity of escalating dose levels of the vaccine candidate.

30,000-Patient trial set

Pfizer and BioNTech said further data from the Phase I/II trials of the four vaccine constructs will enable the selection of a lead candidate and dose level for an anticipated global Phase IIb/III safety and efficacy study in as many as 30,000 patients. That study may begin as soon as later this month.

BNT162 is also under study in China, where the companies’ partner company Fosun Pharma said July 14 that a subsidiary received acceptance of its clinical trial application for BNT162b1 by China’s National Medical Products Administration.

Through Operation Warp Speed, HHS and participating agencies have committed sums ranging from hundreds of millions of dollars to more than $1 billion developers of several other COVID-19 vaccine candidates that are in advanced clinical studies —including $1.2 billion to AstraZeneca toward AZD1222, being developed with University of Oxford and a spinout company; $483 million to Moderna toward mRNA-1273; and $1.6 billion to Novavax toward NVX-CoV2373.

BioNTech and Pfizer also announced Monday that they committed to supplying the U.K. with 30 million doses of their BNT162, to be delivered this year and next. Financial terms were not disclosed

In addition to engaging with the U.S. and U.K. governments, Pfizer and BioNTech have provided an expression of interest for possible supply to the COVAX Facility, a mechanism established by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and World Health Organization (WHO) that is designed to provide governments with early access to a large portfolio of COVID-19 candidate vaccines using various technology platforms, produced by multiple manufacturers worldwide.

“We are also in advanced discussions with multiple other government bodies and we hope to announce additional supply agreements soon,” stated Ugur Sahin, MD, CEO and co-founder of BioNTech. “Our goal remains to bring a safe and effective COVID-19 vaccine to many people around the world, as quickly as we can.”

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