The United States Food and Drug Administration (FDA) on Friday directed Johnson & Johnson (J&J) to discard 60 million doses of its single-shot COVID-19 vaccination made at Baltimore plant, Maryland, U.S.
J&J is an American multinational corporation founded in 1886 that develops medical devices, pharmaceuticals, and consumer packaged goods.
In April 2020, it entered a partnership with Catalent Pharmaceutical Company to provide large-scale manufacturing of the J & J vaccine for COVID at Catalent’s Bloomington, Indiana facility.
The U.S. agency said the shots made at the troubled Baltimore plant had to be thrown away due to potential contamination.
The plant, operated by the company Emergent BioSolutions, is the same one that had manufacturing issues with the same vaccine back in April.
Earlier, the health agency allowed approximately 10 million doses to be used in the U.S. and other countries.
However, they will come with a warning that the agency cannot guarantee the manufacturing plant followed good manufacturing practices.
The plant, had in April, lost up to 15 million vaccine doses, according to reports.
“This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine.
“This batch was never advanced to the filling and finishing stages of our manufacturing process,” J&J said in a statement at that time.
As the COVID-19 vaccine efforts continues to scale up in developing countries and the U.S. government had made a commitment to donate COVID-19 vaccines, this could cause timely delays.
The Biden administration is expected to send 500 millions of doses of vaccines abroad to almost 100 countries in need, however, this was still evolving as no updates had been made on vaccine distribution. (NAN)