Shut-down Baltimore vaccine plant cleared to return to operation by FDA

A Baltimore factory that had to be shut down by the U.S. Food and Drug Administration (FDA) in April will return to operation soon.

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

In April, J&J had to trash millions of doses of its vaccine after the plant mixed-up  ingredients with those of the AstraZeneca vaccine.

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

Emergent did not say exactly when production will resume at the factory.

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

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

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

‘Based upon our current observations of the implemented corrective actions, FDA does not object to the resumption of manufacturing,’ the FDA wrote to Emergent in a letter obtained by The Journal. 

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

In June, however, the FDA ordered millions of doses produced at that factory be discarded due to the contamination. 

AstraZeneca vaccines produced at the factory have not yet been cleared for use.

Once the factory reopens and is operating at full capacity, up to 120 million doses could be produced every month. 

Since April, FDA inspectors have combed the factory and reviewed security camera footage to identify lapses in handling material inside the factory and worked with Gaithersburg, Maryland-based Emergent to resolve a host of problems.

Among the issuses include unsanitary conditions and poorly trained workers.

The agency also has been reviewing data on months’ worth of vaccine substance made in the factory and has allowed several large batches of vaccine doses made from it to be released for distribution.

Emergent is one of several J&J contractors that produce its one-shot vaccine in bulk.

The concentrated vaccine then is shipped to other factories for final steps, including diluting them to the correct strength, putting them in vials and packaging them up.

The lapses at the Baltimore factory have hampered J&J’s efforts to be a major player in vaccinating people, particularly in remote areas and poor countries, given that it’s the only drug maker with an authorized vaccine that only requires one dose and standard refrigeration. 

It’s also cheaper than some other vaccines.

Issues in Baltimore are not the only hurdle the vaccine has faced, however.  

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 severe blood clots were found in people who had received the vaccine.  

Mike Duggan, mayor of Detroit, even declined the city’s initial allotment 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 am 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 revised the vaccine’s label, adding a warning that the shot had been linked to Guillain-Barré, a rare auto-immune disorder where a person’s immune system attacks their own nerves.  

The J&J vaccine has been administered just 13.2 million times in the U.S., a total dwarfed by the 191.5 million times the Pfizer vaccine has been used and the 138.2 million uses of the Moderna vaccine. 

Read more at DailyMail.co.uk