U.S. federal health authorities say sanitary conditions at a plant contracted to make raw materials for Johnson & Johnson’s (COVID-19) vaccine are substandard.
The U.S. Food and Drug Administration (FDA) on Friday ordered Emergent BioSolutions to suspend production and inspected the plant’s manufacturing facilities to address “potential quality issues,” according to a Securities and Exchange Commission (SEC) filing.
In a statement, the FDA wrote: “The FDA cited numerous observations regarding the facility’s processes and compliance with our requirements and standards.”
These observations (pdf) included “cross-contamination” of vaccine material, that the building used for manufacturing was “not maintained in a clean and sanitary manner” and was not suitable for “maintenance of cleanliness, maintenance, and proper operation. “.
The FDA has not authorized this facility to sell or distribute vaccine materials, and to date, none of the vaccines produced at the facility have been distributed in the United States. They will be tested and evaluated again by the FDA before distribution.
Johnson & Johnson said in a statement Wednesday (April 21) that on April 3, they had announced that they would strengthen “oversight of the API manufacturing process at the Emergent BioSolutions Bayview facility, including additional controls and personnel to ensure that our company and FDA quality standards are met. “.
“Johnson & Johnson will exercise oversight to ensure that all FDA comments are addressed in a timely and comprehensive manner. The company will also redouble its efforts to get drug ingredients manufactured by Emergent Bayview, authorized for emergency use in the United States as soon as possible.”
Earlier this month, federal health authorities suspended the use of Johnson & Johnson vaccines to clarify the cause of blood clot symptoms in some vaccine recipients.
The FDA wrote on April 13: “Out of an abundance of caution, the FDA and CDC are recommending suspension of Johnson & Johnson’s COVID-19 vaccine while we review data from six cases in the United States that developed a rare and severe clotting symptom after receiving this vaccine.”
According to the Centers for Disease Control and Prevention (CDC), as of April 21, 134 million people (40.5 percent of the U.S. population) had received at least one dose of the vaccine, and 87.59 million people (26.4 percent of the U.S. population) had been fully vaccinated.
The Vaccine Adverse Event Reporting System (VAERS) recorded 3,005 deaths following COVID-19 vaccination between December 14, 2020, and April 12, 2021. Approximately more than 189 million doses of vaccine were distributed during this time period.
Emergent BioSolutions did not respond to requests for comment at press time.
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