The U.S. Government, via the Department of Health and Human Services and the Department of Defense in a bid to meet the goals established in Operation Warp Speed to begin delivering 300 million doses of vaccine starting in January 2021 have procured 1.95 billion worth of experimental vaccine product known as BNT162 from Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq: BNTX). In an unprecedented deal size, the government will receive 100 million doses of the product, assuming that A) Pfizer can successfully manufacture that amount, and B) the company successfully obtains approval or emergency use authorization from the U.S. Food and Drug Administration (FDA).
The Pressure is on: Operation Warp Speed
As TrialSite introduced, Operation Warp Speed places unprecedented pressure on all participating to drive results, especially for those vaccine developers that are targeting the established data by President Donald Trump: January 2021. Just around the corner, a confluence of money, federal power and life science research converge in a dynamic, big-stakes pressure cooker that could result in unrivaled success or large tax payer losses. In a way, Art of the Deal has come to biotech in the age of the COVID-19 pandemic.
The deal sizes continue to grow as the U.S. federal government has already committed $1.6 billion to Novavax, $1 billion to AstraZeneca and others. In this transaction, the government will pay the companies $1.95 billion upon the receipt of the first 100 million doses, following FDA authorization or approval. The U.S. government can also acquire up to an additional 500 million doses. As part of the deal, the federal government is committing to offer the vaccine for free.
Of course, underlying this unprecedented procurement run is the absolute damages this pandemic has caused U.S. society. With tens of millions out of work and the economic damages not fully understood as of yet, the Operation Warp Speed imperative is to find successful vaccines and therapies with an emphasis on the former by January 2021. Alex Azar, HHS Secretary, commented, “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.” Azar continued, “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.”
This experimental vaccine platform is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. The BNT162 vaccine candidates are experimental or investigational, meaning they are not approved and still are under investigation in clinical studies. BioNTech is the market authorization holder worldwide and will hold all trademarks for the potential product.
BioNTech CEO, Ugur Sahin, who recently became a billionaire thanks to the stock price, reports “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. 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.”
Promising Data Points but Not Near the Finish Line
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 1st, 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 20th, the companies announced early positive update from German Phase 1/2 COVID-19 vaccine study, including first T Cell response data.