The new production was discontinued at the request of the FDA, Dr. Janet Woodcock, acting FDA commissioner, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a joint statement released Wednesday.
“For the vaccines already produced, the products will undergo additional testing and rigorous evaluation to ensure their quality before distribution,” said Woodcock and Marks. “We will not allow a product to be released until we are sure that it meets our quality expectations.”
In the new report, the FDA says that Emergent has not thoroughly investigated the cross-contamination of a batch of viral vaccines with drugs, and that there has not been an in-depth assessment of how people move around the facility as a potential source of contamination.
“There is no guarantee that other batches have not been subject to cross-contamination,” the report said.
Based on images from security cameras and direct observation, the FDA report says written procedures to prevent cross-contamination are not followed or documented during manufacturing. Components and product containers were not handled or stored in a way to prevent contamination; written procedures to ensure that drug substances are manufactured of the correct quality, strength and purity “are inadequate”; and employees were not properly trained.
The building used to manufacture the vaccine drug was not of a suitable size or design to facilitate cleaning and proper surgery, and the equipment used “is not of a size enough” to function as intended, the report said.
In addition, the FDA inspection document lists peeling paint, unsealed bags of medical waste, residue on walls and damaged floors, and rough surfaces that “do not allow for adequate cleaning and disinfection.”
In a statement, Emergent said it is “committed to working with the FDA and Johnson & Johnson to quickly resolve the identified issues.”
J&J is seeking license for Emergent factory
Changes have already been made to reduce the risk of contamination at the Baltimore plant.
Johnson & Johnson was also contracted to fully take over production of the vaccine at the Emergent plant. The independent manufacturing company does not yet have FDA clearance to manufacture or distribute Johnson & Johnson vaccines or components, and no factory-manufactured vaccine has been distributed for use in the United States.
“Johnson & Johnson will exercise its regulatory authority to ensure that all comments from the FDA are promptly and fully addressed,” the company said on Wednesday.
In the meantime, Johnson & Johnson said it has expanded the number of production sites to 10, in addition to the internal production site in the Netherlands.
“We are working around the clock to develop and broadly activate our manufacturing capabilities to deliver our COVID-19 vaccine globally, and we appreciate the continued and extensive collaborations and partnerships we have with governments, health authorities and other companies to create a end this pandemic, ”it said.
No vaccines will go out ‘unless the FDA is pretty sure’
The actions surrounding Emergent have nothing to do with the pause in the use of Johnson & Johnson’s shot in the United States.
Nearly 8 million people in the United States have been vaccinated with the Johnson & Johnson Covid-19 vaccine, but its administration was halted after the U.S. Centers for Disease Control and Prevention and the FDA identified six cases of rare, serious blood clots among people taking got. .
Emergent’s situation is unlikely to influence or reverse any decision about the possible resumption of Johnson & Johnson vaccinations in the future, Dr. Anthony Fauci, chief medical adviser to President Biden, told CNN’s Victor Blackwell on Wednesday.
“I don’t think this will be a factor in whether or not to take the CDC and the Advisory Committee on Immunization Practices, and ultimately the FDA,” said Fauci, director of the National Institute on Allergy and Infectious Diseases. .
“The decision of what to do with this vaccine as a vaccine product will not be affected by that. It will be affected by the data and safety – not what is going on there,” Fauci said. “But you can be sure, and the American public can be sure, that no vaccines will go out unless the FDA is pretty sure about it.”