The Trump administration's Warp Speed initiative has placed its biggest bet yet on an accelerated COVID-19 vaccine—and Pfizer and BioNTech are the lucky recipients.
The vaccine partners landed an initial order from the U.S government for 100 million doses of their mRNA-based COVID-19 vaccine at the eye-popping price tag of $1.95 billion, they said in a joint release Wednesday.
The enormous order is the single largest pledge so far from the Trump administration's Warp Speed initiative to rapidly develop and distribute effective vaccines for COVID-19.
The U.S. Department of Health and Human Services' (HHS') Biomedical Advanced Research and Development Authority (BARDA) will collect the first 100 million doses following an FDA approval or emergency authorization, Pfizer said. The government will then have the option of ordering an additional 500 million doses in the future at an undetermined cost.
BARDA and the Trump administration will distribute Pfizer's vaccine for free to U.S. patients—although taxpayers will ultimately foot the bill.
The supply pact puts hard numbers to Pfizer and BioNTech's agreement with HHS and the U.S. Department of Defense to supply up to 300 million doses of their vaccine stateside by the end of 2021. The partners have stated their goal of producing 100 million vaccine doses by the end of 2020 and 1.3 billion doses total by the end of 2021.
Last week, Pfizer and BioNTech inked a deal with the U.K. government to supply 30 million doses of their vaccine, which will enter phase 2b/3 trials later this month.
The drugmakers are studying four vaccine candidates as part of their BNT162 program, Pfizer said. Last week, the FDA fast-tracked its review of two of those hopefuls—BNT162b1 and BNT162b2—both of which are currently in phase 1/2 trials.
Monday, the partners released new data from the BNT162b1 studies showing a dose-dependent response of neutralizing antibodies for SARS-Cov-2 and elevated T cells in 60 patients.
The companies said a regulatory filing could come as early as October, teeing up a possible early emergency use authorization by the fourth quarter if the vaccine proves effective in preventing severe COVID-19 infection, at the very least.
Meanwhile, Pfizer and BioNTech have been hard at work piecing together supply pacts around the globe.
The partners said Wednesday they "provided an expression of interest" to supply the COVAX facility, a joint endeavor from Gavi, the Vaccine Alliance; the Coalition for Epidemic Preparedness Innovations; and the World Health Organization that acts as a clearinghouse, of sorts, to provide global pandemic vaccines to developing nations.
The companies are also reportedly in talks with the EU for an additional supply pact alongside other major players in the race, including Johnson & Johnson, Moderna and CureVac.
To help fund their expansive distribution goals, BioNTech said Wednesday it would offer roughly $492 million in stock with Pfizer pledging to purchase around $200 million on its own.
Cash raises for COVID-19 vaccine makers aren't uncommon as potential demand for a functional shot stretches into the billions. Earlier this week, German vaccine maker Curevac closed a $642 million financing round as it pursues its own mRNA-based vaccine. British drugmaker GlaxoSmithKline—which is partnering with Sanofi on their own COVID-19 shot—put $100 million into that investment round.