The FDA halted vaccine production at the J&J plant in Baltimore, where health code violations were found.
On Wednesday, April 21, U.S. President Joe Biden announced that since he entered the White House, U.S. residents have received 200 million doses of the vaccine – double the original goal of 100 million. President Biden called this “an incredible achievement for the nation” and announced that employers who provide paid time off for employees to get vaccinated will receive additional tax breaks.
“No working American should lose a single dollar from their paycheck just because they do their patriotic duty and get vaccinated,” the White House chief said.
Meanwhile, the federal Food and Drug Administration (FDA) issued a press release Wednesday saying that a pharmaceutical factory in Baltimore, which received a large order to produce the COVID-19 vaccine from Johnson & Johnson, was found to have violations of health regulations. Poorly trained factory personnel did not follow proper manufacturing procedures, leading to contamination of one of the ingredients for the vaccine.
The 13-page report released by the FDA details the results of a just-completed inspection of the Emergent BioSciences factory, whose operations are currently suspended.
Agency inspectors said a batch of the drug substance for the J&J vaccine was contaminated with material that was used to make AstraZeneca vaccines, another Emergent BioSciences customer. The batch of the substance, which reportedly could have been enough to create 15 million doses of the vaccine, had to be disposed of.
Other problems listed in the inspection report included peeling paint and “brown and black” fouling on floors and walls, lack of cleanliness, and a lack of employee compliance with hygiene standards.
The FDA noted that none of the vaccines produced at the plant were used as intended. Nearly 8 million doses of the J&J vaccine already administered to U.S. residents were imported from Europe.
Executives at Emergent and Johnson & Johnson said Wednesday that they are working to “fix the problems as quickly as possible.”
After problems with the quality of production became known late last month, J&J took control of the plant. The Biden administration is now working to move AstraZeneca’s vaccine production to another factory. The developers of AstraZeneca have not yet sought emergency approval for the use of their vaccine in the United States.
According to the federal office, all vaccine production materials, as well as the first batches produced, packaged and packaged by other J&J contractors, are still being held at the plant and will undergo additional testing for now.
“We are doing everything we can to ensure that the COVID-19 vaccines administered to people in this country meet high standards of quality, safety and efficacy,” the FDA said.
Use of the J&J vaccine is currently on hold in the U.S. as health authorities investigate the drug’s possible association with a very rare complication of thrombosis. A decision to resume use of the vaccine could be made Friday.
The European Medicines Agency’s safety panel concluded Tuesday that thrombosis is an extremely rare side effect and that the benefits of the vaccine outweigh the risk.
Emergent BioSciences, a little-known drug maker, was given an important role in the Trump administration’s vaccine development and manufacturing plan. According to documents obtained by the Associated Press, the company has repeatedly been cited negatively by the FDA for numerous problems, from poorly trained personnel to cracked vials and mold at one of its industrial facilities.
After contaminating a batch of J&J vaccine, FDA inspectors began inspecting Emergent’s Baltimore factory April 12 and concluded their investigation Tuesday.
They also reviewed surveillance footage showing employees carrying open bags of drug waste around the factory, with the bags coming into contact with materials used to make the vaccine.
The footage also shows employees moving between the two vaccine production sites without documenting whether they changed protective gowns or showered between moving to another site, and removing protective clothing near the finished ingredients for vaccine production. Clothing was simply thrown on the floor and then discarded in open trash cans.
The report notes that Emergent management did not sufficiently investigate the circumstances surrounding the contamination of J&J vaccine ingredients and did not appear to have done any additional cleaning