The Food and Drug Administration is investigating what caused a batch of the active ingredient for Johnson & Johnson’s JNJ -0.92% Covid-19 vaccine to be scrapped for failing to meet quality standards at a contract manufacturing plant, according to a person familiar with the matter.
The FDA may send an inspection team to assess the situation at the Baltimore plant operated by contractor Emergent BioSolutions Inc., EBS -13.40% the person said.
The regulatory scrutiny follows J&J’s disclosure Wednesday that a batch of the main ingredient for its Covid-19 vaccine manufactured at the Emergent plant didn’t meet standards. The batch didn’t reach the vial-filling and finishing stage, and no doses from it were distributed.
J&J says the quality lapse didn’t affect vaccine doses that have been distributed in the U.S. since the vaccine was authorized in late February, and the company still has enough supply to meet near-term commitments. J&J also makes the main ingredient for the vaccine at its own plant in the Netherlands.
Emergent BioSolutions, of Gaithersburg, Md., said in a statement Thursday that it isolated the batch of vaccine ingredients because it didn’t meet specifications and quality standards. Emergent said it would dispose of the batch properly.
The company said that discarding a batch is disappointing but occasionally happens during the complex vaccine manufacturing process.
The White House said Thursday it didn’t expect the issue to affect the promised U.S. supply of J&J’s vaccine. J&J expects to deliver about 100 million doses for use in the U.S. by midyear, under the terms of a $1 billion purchase agreement with the federal government.
“We have been assured that they expect to meet those deadlines,” White House press secretary Jen Psaki said at a briefing.
Ms. Psaki said “the issue was identified as part of rigorous quality control system checks,” and the Department of Health and Human Services notified the White House late last week.
Asked if the White House should have revealed the problem publicly earlier, Ms. Psaki said the plant hasn’t yet been FDA-approved. “This is probably the process of working as it should,” she said. Drug plants can manufacture ingredients for a drug or vaccine, but finished products can’t be released until the FDA authorizes them.
J&J’s vaccine is the third to be authorized in the U.S., after shots from Pfizer Inc. with its partner BioNTech SE, and Moderna Inc. Health authorities have been counting on the arrival of the single-shot J&J vaccine to boost the overall supply of shots and to simplify vaccinations because it doesn’t require a second dose.
Emergent said that it was confident in its ability to meet FDA requirements.
Emergent makes the main ingredient for AstraZeneca PLC’s Covid-19 vaccine at the same plant, though that vaccine isn’t authorized for use in the U.S. An AstraZeneca spokeswoman said the company was “aware of the reports regarding the facility and we understand Emergent is investigating the matter.”
Emergent Chief Executive Robert Kramer told CNBC Thursday “it wasn’t the case where an ingredient from one vaccine contaminated or impacted the other.” He said the J&J batch didn’t meet quality specifications but he didn’t elaborate on what happened.
Vaccine manufacturing experts say the issues at the Emergent plant have to be addressed, but the detection of the problem, before doses from the batch were released, was an encouraging sign.
“It’s definitely alarming but it also shows that this is a system that eventually works,” said Tinglong Dai, associate professor of operations management and business analytics at Johns Hopkins University’s Carey Business School, who has researched the vaccine supply chain. “I have high confidence in the error detection part.”
J&J said it was sending additional experts in manufacturing, technical operations and quality to be on-site at Emergent to oversee all manufacturing of the J&J vaccine there.