Baltimore Vaccine Plant Shutdown, Ready to Return to Operation by FDA

A Baltimore factory that was forced to close by the U.S. Food and Drug Administration (FDA) in April will soon be back in operation.

Emergent BioSolutions, which was contracted to manufacture the Johnson & Johnson and AstraZeneca vaccines at the facility, confirmed the news on Thursday. The Wall Street Journal.

In April, J&J had to throw away millions of doses of its vaccine after the plant swapped ingredients with those of the AstraZeneca vaccine.

After a thorough review, the FDA found that the vaccines had been produced in unsanitary conditions and the workers had not been properly trained.

Emergent has not said exactly when production will resume at the plant.

A Baltimore factory that was forced to close after producing contaminated doses of Johnson & Johnson vaccine will reopen soon

The factory (above) was forced to close after Johnson & Johnson vaccines were contaminated with AstraZeneca vaccine ingredients, and a further investigation found unsanitary conditions

The factory (above) was forced to close after Johnson & Johnson vaccines were contaminated with AstraZeneca vaccine ingredients, and a further investigation found unsanitary conditions

“Based on our current observations of the corrective actions implemented, the FDA has no objection to the resumption of production,” the FDA wrote to Emergent in a letter obtained by The Journal.

Up to 30 million doses produced by the plant before its closure could potentially be FDA-approved for use.

However, in June, the FDA ordered millions of doses produced at that plant thrown away because of the pollution.

Factory-produced AstraZeneca vaccines are not yet approved for use.

Once the factory reopens and is running at full capacity, up to 120 million doses can be produced each month.

Since April, FDA inspectors have searched the plant and viewed CCTV footage to identify defects in material handling at the plant and have worked with Gaithersburg, Maryland-based Emergent to resolve a host of issues.

Problems include unsanitary conditions and poorly trained workers.

The agency also reviewed data on factory-made vaccine substance for months and allowed several large batches of vaccine doses made from it to be released for distribution.

Emergent is one of several J&J contractors producing its one-time vaccine in bulk.

The concentrated vaccine is then sent to other factories for final steps, including dilution to the correct strength, vialization and packaging.

The Baltimore plant failures have hampered J&J’s efforts to be a major player in vaccinating people, particularly in remote areas and poor countries, as it is the only drug manufacturer with an authorized single-dose vaccine. and standard cooling required.

It is also cheaper than some other vaccines.

Problems in Baltimore aren’t the only hurdle the vaccine has faced, however.

The use of the vaccine was paused by the FDA and the U.S. Centers of Disease Control and Prevention (CDC) in April after 13 cases of rare or serious blood clots were found in people who had received the vaccine.

Mike Duggan, mayor of Detroit, even refused initial allotment of the city of the J&J vaccine in March, saying the Pfizer and Moderna vaccines were better.

“So Johnson & Johnson is a very good vaccine. Moderna and Pfizer are the best. And I’m going to do everything I can to make sure the residents of the city of Detroit get the best,” Duggan said.

Earlier this month, the FDA revising the vaccine label, with a warning that the shot had been linked to Guillain-Barré, a rare autoimmune disease in which a person’s immune system attacks their own nerves.

The J&J vaccine has only been administered 13.2 million times in the US, in total less than the 191.5 million uses of the Pfizer vaccine and the 138.2 million uses of the Moderna vaccine.