FDA greenlights batches of J&J COVID-19 vaccine from embattled Emergent site: report

Emergent BioSolutions Bayview plant
The FDA authorized additional batches of Johnson & Johnson’s COVID-19 vaccine. (Emergent BioSolutions)

The FDA authorized two more batches of Johnson & Johnson’s COVID-19 vaccine produced at the Emergent BioSolutions Bayview facility, where the company halted production in April due to contamination issues that resulted in millions of doses being thrown out.

After manufacturing snafus led to a temporary shutdown of the site, the Maryland facility scored approval in July to resume production of the J&J vaccine following extensive reviews and coordination with the agency. This week, FDA authorized two more batches to be shipped out, The Baltimore Sun reports

With the new approvals, the Emergent facility has scored the green light to ship out eight batches, the newspaper reports. It's unclear how many vaccine doses are in each batch.

“We remained focused on helping secure the release of additional batches of vaccine drug substance under FDA review and returning to full production of J&J’s vaccine drug substance as soon as possible,” Emergent spokesman Matt Hartwig told The Baltimore Sun.

J&J contracted with Emergent in 2020 for large-scale drug substance manufacturing at the Bayview facility, as did AstraZeneca for its COVID-19 vaccine, which is currently not authorized for use in the U.S.

RELATED: Emergent wins FDA all-clear to restart J&J COVID-19 vaccine production in Baltimore

The saga of the Bayview facility began in March when out-of-specification test results raised red flags. After additional tests by J&J uncovered the batch had been contaminated, regulators combed the plant, flagging it for cleanliness and quality control issues.

The problems resulted in the launch of a congressional investigation into Emergent that could put the company’s lucrative federal contract at risk.