FDA: Throw Out 60 Million COVID-19 Vaccine Doses

The Food and Drug Administration (FDA) has asked Johnson & Johnson to throw out 60 million doses of its single-shot COVID-19 vaccine, Ad26.COV2.S, due to potential contamination issues, created at a manufacturing plant in Baltimore. The plant, operated by the company Emergent BioSolutions, is the same one that had manufacturing issues with the same vaccine back in April.

This latest news comes from a report in the NY Times.

According to the report, FDA will allow approximately 10 million doses to be used in the US and other countries; however, they will come with a warning that the agency cannot guarantee the manufacturing plant followed good manufacturing practices.

The single-shot COVID-19 vaccine was developed by Janssen Pharmaceutical Companies of Johnson & Johnson, and has had some challenges along the way. Also in April, the FDA recommended a pause in the administration of the Ad26.COV2 vaccine after it was reported that a small number of people who were vaccinated with it developed cerebral venous sinus thrombosis (CVST) in combination with low-levels of platelets in the blood (thrombocytopenia) 6-13 days after vaccine administration.

A couple of weeks later, the United States Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to reaffirm recommendation of the vaccine.

Back in April, the plant lost up to 15 million vaccine doses, according to a report.

"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 US government had made commitments to donate millions of doses of COVID-19 vaccines, this could cause timely delays. The Biden administration expected to send both the Johnson & Johnson and AstraZeneca vaccines abroad to countries in need. As this is evolving, no updates have been made on vaccine distribution.