Johnson & Johnson vaccine: Baltimore plant quality issue delays part of J&J supply

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The New York Times reported on Wednesday. that workers at Emerg BioSolutions, the Baltimore plant that made Johnson & Johnson’s Covid-19 vaccine, accidentally mixed up some of the ingredients, ruining up to 15 million potential doses of the vaccine and delaying the authorization of the factory by the US Food and Drug Administration.

Emergent also manufactures the AstraZeneca vaccine, which has not yet been approved for use in this country.

Johnson & Johnson said in a statement to CNN on Wednesday that the plant’s quality control process had identified “a batch” of drug substance that did not meet quality standards. The batch in question was part of testing and quality control. The site is not yet cleared by the FDA to manufacture the drug substance used in the vaccine.

“This batch has never been advanced to the filling and finishing stages of our manufacturing process,” the company emailed statement read.

None of the doses lost affect the company’s goal of delivering 20 million doses of the Covid-19 vaccine by March. For that, the company said on Wednesday that it is on the right track. These doses come from J&J’s Janssen vaccine plant in the Netherlands.

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“This is an example of the rigorous quality control applied to each batch of drug substance. The problem has been identified and addressed with Emergent and shared with the United States Food & Drug Administration (FDA),” the statement said.

“Quality and safety remain our top priority. Therefore, as we continue to work with the FDA and Emergent towards emergency use clearance for the Emergent Bayview facility, Johnson & Johnson is providing expert advice. additional manufacturing, technical operations and quality. -site at Emergent to oversee, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine. In coordination with the US Department of Health and Human Services, these steps will allow us to safely deliver 24 million additional single-dose vaccines through April. “

The FDA told CNN it was “aware of the situation, but we are unable to comment further” and referred CNN to J&J. The maker, Emergent, also referred CNN to J&J.

Emergent makes the vaccines in its factory, then ships the equipment to other factories for what’s called filling and finishing – the process of putting the vaccine into vials and finishing the packaging.

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On Wednesday evening, officials in the Biden administration stressed that the quality issue with the Johnson & Johnson manufacturing plant in Baltimore would not affect the president’s ultimate goal of making vaccines available to all Americans. here may.

The White House said J&J told them to still expect 24 million doses of their vaccine for next month – although officials have warned that it depends on J&J, given questions about their production times.

Officials were frustrated with what happened in the past 24 hours, but stressed that it did not affect any of the J&J vaccines given in the United States. How this affects the authorization of the production lines at the Emergent plant also remains to be seen.

Last week, the Biden administration expressed doubts about the company’s ability to meet its self-imposed deadline, but on Friday the administration seemed more confident that J&J would hit its target, as the ‘White House Coronavirus Coordinator Jeffrey Zients said, “they appear to be on track to meet this target with at least 11 million doses delivered next week.”
The FDA cleared J & J’s single-dose Covid-19 vaccine at the end of February, but the company had struggled to ramp up production and missed previous production deadlines that were set in its contract with the federal government.
The Biden administration has worked with the three licensed vaccine manufacturers to increase the supply of Covid-19 vaccines. President Joe Biden used the Defense Production Act to acquire new materials and equipment and negotiated a rare partnership between J&J and pharmaceutical rival Merck & Co., to manufacture more vaccines. This vaccine supply will not be available until later this year.

In February, J&J also said it was working to develop its own manufacturing capacity and increasing the number of third-party vaccine manufacturers it worked with.

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