The Food and Drug Administration is investigating what caused a batch of the active ingredient for Johnson Johnson's 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 the company Emergent BioSolutions Inc.
The regulatory scrutiny follows J& J's disclosure Wednesday that a batch of the main ingredient for its Covid 19 vaccine manufactured in the Emergent plant did n't meet standards. The batch did not reach the vial-filling and finishing stage and no doses from it were distributed.
J& J says the quality lapse did not affect vaccine doses that have been approved in the U.S. since the vaccine was distributed 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 did n't meet specifications and quality standards.
Emergent said it would dispose of the batch properly; GET FOX BUSINESS ON THE GO BY CLICKING HERE.
The company said that discarding a batch is occasionally unpleasant but happens during the complex vaccine manufacturing process.
The White House said Thursday that it did n'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 mid-year under the terms of a$ 1 billion buy agreement with the federal government.
The White House Press Secretary Jen Psaki said at a briefing that they expect to meet these deadlines.
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 whether the White House should have disclosed the problem earlier, Ms. Psaki said the plant has n't yet been FDA-approved. This is probably the whole process of working as it should, said she. Drug plants can manufacture ingredients for a drug or vaccine, but finished products ca n't be released until the FDA approves them.
COMPANY BEHIND J& J COVID- 19 VACCINE BLUNDER CITED FOR CRACKED VIALS, MOLD ISSUES IN PAST, REPORT REVEALS The J& J vaccination is the third to be approved in the U.S. after shots from Pfizer Inc. and Moderna Inc. Health authorities have been counting on the arrival of the single shot J& J vaccine to increase the overall supply of shots and simplify vaccinations since it does n't require a second dose.
Emergent said that it was confident in its ability to meet FDA requirements.
Emergent makes the main ingredient for the AstraZeneca PLC Covid- 19- vaccine at the same plant, though this vaccine is n't authorized for use in the US.
An AstraZeneca spokeswoman said the company was aware of the reports regarding the facility and we understand Emergent is investigating the matter.
Chief Executive Robert Kramer told CNBC Thursday that it was n't the case where an ingredient from one vaccine impacted or contaminated the other. He said the batch of J& J did n't meet quality specifications, but he did not elaborate on what happened.
Vaccine manufacturing experts say that 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.
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It is definitely alarming but it also shows that this is a system that eventually works, said Tinglong Dai, professor of operations management and business analytics at Carey Business School who has researched the vaccine supply chain. I have high confidence in the part of error detection.
J& J said it was sending additional technical experts in manufacturing, technical operations and quality to be at Emergent to oversee all production of the J& J vaccine there.