- The U.S. government has recruited contract drug manufacturer Emergent BioSolutions to aid in its ambitious efforts to develop, make and distribute a coronavirus vaccine by early next year, announcing Monday plans to pay the Maryland-based company more than half a billion dollars for vaccine production and assembly.
- Part of 'Operation Warp Speed,' the government's contract promises up to $543 million to secure manufacturing capacity for coronavirus vaccine candidates at Emergent's three facilities in Maryland through 2021. The government will also invest $86 million to boost Emergent's capabilities for "filling and finishing" drug vials under sterile conditions.
- Emergent has worked with the U.S. government, through the Biomedical Advanced Research and Development Authority, since 2012. The newly announced contract will expand that partnership, adding on to work the contract company is already doing with coronavirus vaccine developers Johnson & Johnson and Novavax.
'Operation Warp Speed', an aggressive project announced last month by the White House, aims to accomplish in months what normally takes many years. A large part of that effort is committing to manufacturing vaccine candidates before testing definitively proves them safe and effective.
BARDA's contract with Emergent isn't for one particular vaccine, but rather to set aside production capacity for the multiple vaccine manufacturers working with the U.S. government. Emergent estimates it can produce tens to hundreds of millions of vaccine doses annually, depending on which type of vaccine it's tasked to produce.
"Before a vaccine is even approved, Emergent’s manufacturing capabilities will pave the way for drug companies with candidates approaching approval to begin turning out doses," Health and Human Services Secretary Alex Azar said in a statement.
So far, BARDA has partnered with J&J, Moderna, Sanofi and AstraZeneca on their coronavirus vaccine research. The agency recently announced plans to invest as much as $1.2 billion to help develop and obtain supplies of AstraZeneca's vaccine, which originated at the University of Oxford.
Emergent has the advantage of being based in the U.S., making it an attractive partner at a time when governments are positioning to ensure supplies of any successful vaccine for their own citizens.
Emergent's center in Baltimore is one of three sites to be designated by BARDA as a Center for Innovation in Advanced Development and Manufacturing, and the first to be tapped for coronavirus-related efforts. The Baltimore site would handle drug substance production under the new BARDA contract, while Emergent's Camden and Rockville, Maryland locations would be responsible for drug product manufacturing.
The $86 million dedicated to building out Emergent's "fill/finish" capabilities is important, too. Large drugmakers like Pfizer, AstraZeneca and J&J are already concerned about limited global capacity for filling vaccine vials, which could become a bottleneck as companies work to produce hundreds of millions or even billions of doses.