A Maryland-based drug maker awarded $628 million by the Trump Administration’s Operation Warp Speed in June 2020 specifically to prepare itself to ramp up production of a then-undiscovered coronavirus vaccine said in a Securities and Exchange Commission filing that it cannot guarantee it will ever be able to produce any vaccines at all.

According to Roll Call, Emergent BioSolutions stated in an SEC report, “The manufacturing processes for our [contract development and manufacturing organization] COVID-19 programs are under development and will be complex.  As a result, there can be no assurance that we will be able to produce any significant quantity of these products in a timely basis or at all.”

Emergent is contracted, through Operation Warp Speed, to make what’s known as “drug substance,” the active ingredient in the vaccine.  The company, however, never gained FDA regulatory approval to make the ingredient in the Johnson & Johnson vaccine, though it was contracted to through Operation Warp Speed to do so for J&J nine months ago.

The delay jeopardizes the ability of J&J to fulfill its obligation to manufacture 20 million vaccine doses by the end of March.  If J&J cannot manufacture all the doses, the federal government has the ability to cancel the contract.

Emergent has a long history with federal government contracts.  It received $1.2 billion in contracts to manufacture biodefense vaccines, specifically for anthrax, as well as the coronavirus vaccine from Strategic National Stockpile, which was headed by Trump appointee Robert Kadlec, a consultant to Emergent until 2015.

Emergent made more than 40% of the anthrax vaccine stockpile.  In July 2020, a month after Emergent contracted to make the coronavirus ingredient in mass amounts, it contracted through the  Assistant Secretary of Health and Human Services (Preparedness and Response), headed by Kadlec, for $258 million, for an as-yet unapproved next-gen anthrax vaccine, NuThrax, which had been in development since 2016.