BOSTON (CBS/CNN) — Drugmaker Johnson & Johnson said Wednesday it had found a quality problem at a Baltimore plant helping manufacture its coronavirus vaccine under contract.
The New York Times reported Wednesday. that workers at Emergent, the Baltimore plant that has been making Johnson & Johnson’s Covid-19 vaccine, accidentally mixed up some of the ingredients, ruining as many as 15 million potential doses of vaccine and delaying US Food and Drug Administration authorization of the plant.READ MORE: Massachusetts' 3 Casinos Have Encouraging Month In March
Emergent is also making the AstraZeneca vaccine which has yet to be authorized for use in this country.
Johnson & Johnson said in a statement to CNN Wednesday that the quality control process at the plant identified “one batch” of drug substance that did not meet quality standards. The batch in question was part of a test run and quality check. The site is not yet authorized by the FDA to make the drug substance used in the vaccine.
“This batch was never advanced to the filling and finishing stages of our manufacturing process,” the emailed statement from the company said.
None of the lost doses impact the company’s goal of delivering 20 million Covid-19 vaccine doses in March. For that, the company said Wednesday, it is on track.
Massachusetts is expected to receive more than 100,000 doses of the vaccine next week. The state’s Covid-19 command center said the news will not impact current appointments.
“At this time, the Administration has not received any notice of delay in shipment of J&J vaccine to the Commonwealth from the federal government, and this week received 383,000 doses as part of the state allocation from the federal government of Moderna, Pfizer and J&J doses. This news does not impact current appointments or allocations for any sites statewide and we remain prepared to work collaboratively with the federal government to avoid any disruption in vaccine shipments,” said Kate Reilly, communications director of the COVID-19 Command Center.READ MORE: Coronavirus In Massachusetts: Today's Developments
Johnson & Johnson said, “This is an example of the rigorous quality control applied to each batch of drug substance.”
“Quality and safety continue to be our top priority. Therefore, as we continue to work with FDA and Emergent toward the Emergency Use Authorization of the Emergent Bayview Facility, Johnson & Johnson is providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine. In coordination with the U.S. Department of Health & Human Services, these steps will enable us to safely deliver an additional 24 million single-shot vaccine doses through April.”
The FDA told CNN it is “aware of the situation, but we are unable to comment further” and referred CNN back to J&J. The manufacturer, Emergent, also referred CNN back to J&J.
Last week, the Biden administration expressed some doubts the company could meet its self-imposed deadline, but by Friday, the administration seemed more confident that J&J would meet its goal, as White House coronavirus coordinator Jeffrey Zients said, “they appear on track to meet that goal with at least 11 million doses delivered next week.”
The FDA authorized J&J’s single-dose Covid-19 vaccine in late February, but the company had struggled to ramp up production and failed to meet earlier production timelines that had been laid out in its contract with the federal government.
The Biden administration has worked with all three authorized vaccine manufacturers to ramp up the supply of the Covid-19 vaccines. President Joe Biden used the Defense Production Act to acquire new materials and equipment and brokered a rare partnership between J&J and pharmaceutical rival Merck & Co., to make more vaccines. That vaccine supply won’t be available until later in the year.
In February, J&J also said it had been working to expand its own manufacturing capacity and was expanding the number of third-party vaccine manufacturers with which it was working.MORE NEWS: Plainville Firefighter In Coma After Contracting COVID-19
(© Copyright 2021 CBS Broadcasting Inc. All Rights Reserved. CNN’s Jen Christensen contributed to this report.)