President Joe Biden’s administration is “assured” that Johnson & Johnson will meet its U.S. vaccine delivery targets despite a setback at a Baltimore site, White House Press Secretary Jen Psaki said.
Psaki spoke Thursday at the White House after J&J and one of its subcontractors, Emergent BioSolutions Inc., acknowledged that a batch of drug substance had been spoiled. She said the U.S. doesn’t expect J&J to miss any delivery targets, and alluded to having some room with a larger supply of Pfizer Inc. and Moderna Inc. The U.S. has said it will have enough vaccine doses for all American adults in May from those companies.
“We have been assured that they expect to meet those deadlines,” Psaki said, when asked about J&J. “We are looking forward to that. Obviously, these are doses that the U.S. government has purchased but we also have plenty of doses from Pfizer and Moderna, regardless.”
The disruption affected a batch of drug substance at a Baltimore plant that isn’t yet authorized to produce doses, and has not provided any to the U.S. so far. It’s not expected to affect Biden’s May target, several people familiar with the matter have said.
Psaki said the Department of Health and Human Services informed the White House late last week, but didn’t say when HHS learned of the problem at the facility.
Flawed Batch
In a statement Thursday, Emergent said it has set up rigorous quality checks that caught the flawed batch. “Through these checks a single batch of drug substance was identified that did not meet specifications and our rigorous quality standards. We isolated this batch and it will be disposed of properly,” it said.
The company called the issue disappointing yet said it “does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process.”
Emergent says it remains “confident” in its ability to meet Food and Drug Administration requirements and receive authorization.
J&J said it remains on pace to deliver the U.S. order by the end of June. The administration has said it wants all of the supply or nearly all of it by the end of May; J&J hasn’t committed to meeting that timeline.
Source: Newmax
