The U.S. government has shelled out big money to help develop a possible COVID-19 vaccine and boost manufacturing of COVID-19 drugs stateside. Now, in order to amp up production of its chosen vaccine hopefuls, the government will enlist a Maryland CDMO to get production quickly up to speed.
Emergent BioSolutions has won a $628 million deal with the U.S. government to scale production of targeted COVID-19 vaccine candidates to make "tens to hundreds of millions" of doses available through 2021, the CDMO said Monday.
The contract is part of the government's "Operation Warp Speed" development initiative to speed promising COVID-19 vaccines through clinical trials and into mass production before the end of 2020.
As part of the agreement, the government will shell out $542.7 million to reserve bulk manufacturing capacity at Emergent's Baltimore Bayview facility, which was constructed as part of a Biomedical Advanced Research and Development Authority (BARDA) pandemic preparedness contract signed in 2012. The remaining $85.5 million will be spent expanding fill/finish capacity at two Emergent plants at Camden in Baltimore and Rockville, Maryland.
The massive order will allow Emergent to set aside the needed manufacturing space to mass-produce what could be two or three promising vaccine candidates identified by BARDA and the U.S. Department of Health and Human Services (HHS), Emergent CEO Robert Kramer said Monday.
The Maryland-based CDMO previously signed manufacturing deals with Johnson & Johnson, Novavax and Vaxart to produce their COVID-19 vaccine candidates at scale, but the BARDA contract would take precedent if other hopefuls beat those three companies to the punch.
"The government has the right to prioritize what work we do in the Baltimore facility," Kramer said. "We’re having a very close dialogue with 'Operation Warp Speed,' HHS and BARDA to make sure we are 100% aligned."
That could mean that Emergent's private partners have to wait their turn at the company's Baltimore facility, but Kramer noted that J&J had already signed an agreement with BARDA to co-develop a possible vaccine. In a deal valued at $135 million, Emergent agreed to set aside some of its manufacturing capacity at the Baltimore Bayview plant to help J&J reach its stated goal of producing up to 1 billion doses of a potential vaccine each year.
But all of the reservations Emergent is taking are ultimately dependent on one thing: Will a vaccine be ready to go in the next couple years? Kramer said the likelihood the U.S. government will identify at least one promising candidate for production later this year is "entirely possible and likely," and the CDMO said it would be ready to roll on scaled-up production immediately.
Emergent, a "public health threat solutions provider" that has most of its manufacturing in the U.S. , sees BARDA's order as a continuation of its sustained business with the government.
"When we say as a company that we are made to do what we are doing right now, that’s exactly what it is," Kramer said.
Emergent will aim to help "Operation Warp Speed" meet its stated manufacturing goals of 100 million doses within the year and up to 300 million doses by the end of 2021, when the order comes to a close, Kramer said.
The government's Emergent deal is only the most recent of the massive contracts BARDA has shelled out in recent weeks to produce COVD-19 drugs and potential vaccines.
In late May, the Trump administration floated a four-year, $354 million contract with a fledgling company, Phlow Corporation, to build a generic medicine and active pharmaceutical ingredient (API) plant in Richmond, Virginia, and supply COVID-19 treatments produced there.
That deal can be expanded up to 10 years and a total of $812 million, making it among the largest in BARDA's history. It's part of the administration's push to boost drug manufacturing on U.S. soil, HHS said in a release at the time.
To fulfill the government deal, Phlow has teamed up with CivicaRx, a generics maker started by hospitals fed up with rising drug prices and API supplier AMPAC, among others. CivicaRx and its partners will manufacture the finished dosage forms of essential medications, including vials and syringes.
The U.S. partnership "immediately enabled" the company to deliver 1.6 million doses of five generic drugs used to treat hospitalized COVID-19 patients, including sedatives for patients on ventilators, to the U.S. Strategic National Stockpile, Phlow said in a release.
Aiming to hedge its bets on a potential vaccine, BARDA has also shelled out big bucks to another drugmaker, AstraZeneca.
In late May, BARDA agree to pay $1.2 billion to access 300 million of AstraZeneca's vaccine doses starting in the fall. AstraZeneca has signed up to deliver 400 million doses through its initial supply agreements, including a U.K. pact for 100 million total doses.
BARDA also agreed in mid-April to pay out $483 million to Moderna to support development of its mRNA vaccine for COVID-19.