After multiple setbacks, FDA authorizes Emergent BioSolutions to resume J&J vaccine production

Emergent BioSolutions.jpg
Posted at 10:28 AM, Jul 29, 2021

BALTIMORE — The U.S. Food and Drug Administration (FDA) has authorized Emergent BioSolutions to resume production of the Johnson & Johnson Covid-19 vaccine at their Bayview manufacturing facility in Southeast Baltimore.

It's been a long process filled with setbacks.

Back in April, Emergent was forced to pause all production of the vaccine after the FDA raised several red flags during a multi-day inspection.

RELATED: FDA raises several concerns with Emergent BioSolutions following inspection

That happened a month after the facility reportedly ruined 15 million doses by mixing up certain ingredients.

Congress also got involved by launching an investigation into how the company ended up with a federal contract to manufacture vaccines in the first place.

In June, the FDA issued their first use authorizations for vaccines manufactured at the facility.

However, it wasn't without difficulty.

The FDA recommended they come with a disclosure stating the batches were not made in total compliance with requirements.

While those doses were ultimately authorized for distribution, another 60 million had to be tossed due to potential contamination and conflation with the AstraZeneca vaccine, which the facility had also been contracted to manufacture.

MORE: FDA authorizes more J & J vaccine doses from Baltimore Emergent facility after 60 million were tossed

“The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves,” said Kramer. “We have fallen short of those lofty ambitions over the past few months but resumption of manufacturing is a key milestone and we are grateful for the opportunity to help bring this global pandemic to an end. We’d like to thank our government partners as well as Johnson & Johnson for their support.”

According to the Maryland Department of Health, only 271,698 Johnson & Johnson doses have been given in the state.