Drugmaker Johnson & Johnson said Wednesday it had found a quality problem at a Baltimore plant helping manufacture its single-dose coronavirus vaccine under contract.
The New York Times reported Wednesday. that workers at Emergent BioSolutions, 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.
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. Those doses come from J&J’s Janssen vaccine plant in the Netherlands.
“This is an example of the rigorous quality control applied to each batch of drug substance. The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration (FDA),” the statement said.
“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.
Emergent manufactures the vaccines at its plant, then ships the material to other plants for what’s known as fill and finish — the process of putting the vaccine into vials and completing the packaging.
On Wednesday evening, Biden administration officials stressed that the quality issue with Johnson & Johnson’s Baltimore manufacturing plant won’t affect the president’s ultimate goal of making vaccines available to all Americans by May.
The White House says J&J has told them to still expect 24 million doses of their vaccine for next month — though officials cautioned this depends on J&J, given questions about their production timelines.
Officials were frustrated by what has happened over the last 24 hours, but emphasized it has not affected any of the J&J vaccines administered in the U.S. How this affects the authorization for the Emergent plant’s production lines also remains to be seen.
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.
