With its Pfizer-partnered COVID-19 vaccine authorized in the U.S., Europe, the U.K. and a slate of other countries, German mRNA specialist BioNTech is wasting no time scaling up its 2021 pandemic ambitions—namely, 2 billion shots by year-end, plus a slate of new approvals and a temperature-stable formulation, too.
BioNTech set its sights on producing 2 billion doses of its pandemic vaccine, now dubbed Comirnaty, this year, up from a previous estimate of 1.3 billion, CEO Uğur Şahin said at the virtual J.P. Morgan Healthcare Conference.
That production boost will rely on six global manufacturing sites tapped in Pfizer and BioNTech’s alliance, including a facility in Marburg, Germany, that's expected to go live by the end of February, the company said. Besides tapping that site, which will have a 75 million-dose capacity, the company plans to call on new suppliers and CMOs, Sahin said.
That’s not all BioNTech promises for the second year of the pandemic fight; the Mainz-based drugmaker plans to simplify storage by rolling out a six-dose vial, and it's eyeing label expansions in children, pregnant women and other sub-populations, too.
Easing distribution is also a goal. Aside from extending Comirnaty’s patient reach, BioNTech is plotting further stability testing for its current formulation—shackled by stringent cold chain requirements—plus a formula free of polyethylene glycol, which may be linked to side effects, and a more temperature-stable version of the shot.
Back in November, Pfizer was already weighing next-generation vaccine formulas to ease Comirnaty’s cold chain concerns. "For the COVID-19 disease, I think we'll roll out next year a vaccine in powder format," Pfizer's chief scientist, Mikael Dolsten, told Business Insider at the time.
With its production estimate dialed up, BioNTech hopes to deliver Comirnaty to upward of 1 billion people globally this year. The company says it has so far shipped 32.9 million doses worldwide.
The partners will need that extra manufacturing firepower as their vaccine distribution network continues to swell.
At the tail end of 2020, Pfizer and BioNTech, later joined by Moderna, kicked off an unprecedented vaccine rollout campaign, and the partners have continued to expand supply deals since then. In mid-December, BioNTech leveraged its agreement with local drugmaker Shanghai Fosun to supply the China mainland with an initial 100 million Comirnaty doses in 2021—assuming the shot passes muster with regulators.
Meanwhile, the U.S. in late December—after a highly publicized back-and-forth with the company—secured an additional 100 million Pfizer doses for a total order of 200 million shots.