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.
CureVac, which is hoping to advance its own candidates to human testing in June, told the Financial Times last week that regulators would need to “abbreviate” the regulatory process for vaccine testing or face the consequences.
“It would take too much time to get a vaccine to market to fight against the current pandemic on time,” a CureVac spokesman said. “To speed this process up, authorities would have to allow us to abbreviate the approval process.”
Pfizer and BioNTech are hoping to advance multiple mRNA vaccine candidates. Under the partnership deal, BioNTech gets $185 million in up-front cash with an additional $563 million in possible milestone payments, the companies said.
The partners will jointly commercialize the vaccine if it is approved, with Pfizer picking up 100% of the development costs.
CureVac said it could produce 1 billion vaccines in one manufacturing run, depending on the dose, once it completed its fourth production facility, which is being built. –Fierce Pharma