The new production has been stopped at the request of the FDA, Dr. Janet Woodcock, the FDA’s acting commissioner, and Dr. Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, said in a joint statement released Wednesday.
“For vaccines already manufactured, the products will be subjected to additional testing and carefully evaluated to ensure their quality before any potential distribution,” said Woodcock and Marks. “We will not allow any product to be launched until we are confident that it meets our quality expectations.”
In the new report, the FDA says Emergent did not investigate in detail the cross-contamination of a batch of viral vaccine drugs and there was no in-depth review of how people moved in and around the facility as a potential source of contamination. .
“There is no assurance that other lots have not been subjected to cross-contamination,” the report said.
Based on safety camera records and direct observation, the FDA report says that written procedures to prevent cross-contamination are not followed during production or documented. Product components and containers have not been handled or stored in a manner that prevents contamination; written procedures to ensure that medicinal substances are manufactured to the appropriate quality, strength and purity “are inadequate”; and employees were not properly trained.
The building used to manufacture the vaccine drug was not the right size or design to facilitate proper cleaning and operation, and the equipment used “is not of the right size” to function as intended, the report said.
In addition, the FDA inspection document notes peeling paint, unsealed bags of medical waste, debris on damaged walls and floors, and rough surfaces that “do not allow for proper cleaning and sanitation.”
In a statement, Emergent said it was “committed to working with the FDA and Johnson & Johnson to resolve the issues quickly.”
J&J is pursuing the authorization for the emerging plant
Modifications have already been made to reduce the risk of contamination at the Baltimore plant.
Johnson & Johnson was also told to take over vaccine production at the Emergent plant. The independent production company does not yet have FDA approval to manufacture or distribute any Johnson or Johnson vaccine or component, and no factory-made vaccine has been distributed for use in the United States.
“Johnson & Johnson will exercise its oversight authority to ensure that all FDA observations are addressed promptly and comprehensively,” the company said in a statement Wednesday.
Meanwhile, Johnson & Johnson said it has increased the number of production units to 10, in addition to the domestic production unit in the Netherlands.
“We work non-stop to broadly develop and activate our production capacity to deliver our COVID-19 vaccine worldwide, and we appreciate the ongoing and extensive collaborations and partnerships we have with governments, health authorities and other companies for to contribute to the end of this pandemic, “he said.
No vaccine will come out “unless the FDA is confident enough”
Actions surrounding Emergent are not related to the break in the use of Johnson & Johnson photography in the United States.
Nearly 8 million people in the United States have been vaccinated with the Johnson & Johnson Covid-19 vaccine, but the administration was stopped after the US Centers for Disease Control and Prevention and the FDA identified six cases of rare and severe blood clots among the people who received it. .
The Emergent situation is unlikely to influence or push back any decision on the possible resumption of Johnson & Johnson vaccinations, Dr. Anthony Fauci, President Biden’s chief medical adviser, said on Wednesday.
“I don’t think that will be a factor in whether the CDC and the Advisory Committee on Immunization Practices and, ultimately, the FDA will make a decision,” said Fauci, director of the National Institute of Allergy and Infectious Diseases. .
“The decision to deal with this vaccine as a vaccine product will not be influenced by that. It will be influenced by data and safety – not by what is happening there,” Fauci said. But you can be sure, and the American public can be sure, that no vaccine will come out of it, unless the FDA is confident enough in them.