On the hunt for a COVID-19 vaccine, Pfizer and BioNTech are laying plans for manufacturing their candidates for trials—and producing millions of doses if trials succeed.
The partners could have "millions" of doses of a COVID-19 vaccine ready to go by year-end if the companies begin human testing as planned by late April, the partners said Thursday.
BioNTech plans to turn out supplies for clinical trials at its European mRNA facility, with the help of its CDMO partner Polymun. Those supplies would fan out to "multiple" sites across Europe and the U.S. for human testing.
If the testing does begin on time—no easy feat given regulatory hurdles—the drugmakers plan to go ahead and scale up manufacturing "at risk," Cantor Fitzgerald analysts wrote in a recent investor note. That way, if they win FDA approval, they could quickly "provide worldwide supply in response to the pandemic," the analysts said.
The two companies say they can rapidly ramp up manufacturing to produce millions of doses by the end of 2020 and churn out "hundreds of millions" in 2021.
But to hit that timeline, the partners need to launch testing by the end of the month, and that's a big "if:" BioNTech and CureVac, another vaccine maker, are hard at work to get regulators to rewrite the rules on vaccine trials to speed their candidates to human subjects.