FDA: Problems at factory making J&J vaccine

The Baltimore factory contracted to make Johnson & Johnson’s COVID-19 vaccine was dirty, didn’t follow proper manufacturing procedures and had poorly trained staff, resulting in contamination of material that was going to be put in the shots, U.S. regulators said Wednesday.

The Food and Drug Administration released a statement and a 13-page report detailing findings from its recent inspection of the nowidle Emergent Biosciences factory.

Agency inspectors said a batch of bulk drug substance for J&J’S single-shot vaccine was contaminated with material used to make COVID19 vaccines for another Emergent client, Astrazeneca. That batch, reportedly enough to make about 15 million J&J vaccine doses, had to be thrown out.

Other problems cited in the inspection report were peeling paint, black and brown residue on floors and walls in the factory, inadequate cleaning and employees not following procedures to prevent contamination.

Nothing made at the factory for J&J has been distributed, the FDA noted. The nearly 8 million doses of J&J vaccine given in the U.S. came from Europe.

Both Emergent and Johnson & Johnson said Wednesday that they are working to fix the problems as quickly as possible.

After quality problems surfaced late last month, J&J took control of the factory. The Biden administration now is working to move Astrazeneca vaccine manufacturing to another factory. Astrazeneca’s vaccine is not yet authorized in the U.S.

The Baltimore factory halted production late last week at the request of the FDA. The agency hasn’t given emergency approval to the factory, which is needed before vaccine material made there can be distributed.

All the bulk vaccine substance Emergent has made, plus early batches made there and then put in vials and packaged by other J&J contractors, are being stored and will undergo additional testing by the FDA, the agency said.

“We are doing everything we can to ensure that the COVID-19 vaccines that are given to the people of this nation have met the agency’s high standards for quality, safety and effectiveness,” the FDA said.

Use of the J&J vaccine is on hold in the U.S. as government health officials investigate its possible connection to very rare blood clots. Their decision on whether to allow the vaccine to be given could come Friday.

On Tuesday, the European Medicines Agency’s safety committee said its review found the blood clots are a very rare side effect but that the J&J vaccine’s benefits outweigh that risk.

Emergent, a little-known drug manufacturing contractor, was granted a major role in the Trump administration’s response to the coronavirus. The company has been repeatedly cited by the FDA for problems ranging from poorly trained employees to cracked vials and mold around one of its facilities, according to records obtained by The Associated Press.