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Quality issue at US plant delays some Johnson & Johnson's vaccine

ANI | Updated: Apr 01, 2021 08:30 IST

Maryland [US], April 1 (ANI): US pharmaceutical giant Johnson & Johnson has found a quality issue at a plant in Baltimore, Maryland helping manufacture its single-dose COVID-19 vaccine. The mix-up has said to have ruined as many as 15 million potential doses of vaccine.
US media reports on Wednesday reported that workers at the Baltimore plant, making Johnson & Johnson's COVID-19 vaccine, mistakenly mixed up some of the ingredients, CNN reported.
Incidentally, the Baltimore plant is also making the AstraZeneca vaccine, which has yet to be authorised for use in the US.
The quality control process at the plant identified "one batch" of drug substance that did not meet quality standards, the company said in a statement, adding that that the batch in question was part of a test run and quality check.
CNN reported that the site is not yet authorised by the United States Food & Drug Administration (FDA) to make the drug substance used in the vaccine.

Johnson & Johnson also stated that none of the lost doses impact the company's goal of delivering 20 million Covid-19 vaccine doses in March.
"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 company 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 US Administration authorised J&J's single-dose COVID-19 vaccine in late February.
The US continues to be the worst affected country by the pandemic with 30,459,105 cases and 552,033 deaths. (ANI)