On April 21, the U.S. Food and Drug Administration (FDA) announced about taking responsibility to ensure medical product quality, COVID-19 vaccines safety and effectiveness very seriously.
“The American public puts its trust in the agency to ensure that all medical products, including COVID-19 vaccines, meet the agency’s standards for quality, safety and effectiveness. As part of our regulatory processes for reviewing all manufacturing facilities, the FDA recently completed an inspection of Emergent BioSolutions, a proposed manufacturing facility for the Johnson & Johnson COVID-19 Vaccine.
As Johnson & Johnson announced the External Link Disclaimer last month, the FDA has not authorized this facility to manufacture or distribute any of Johnson & Johnson’s COVID-19 Vaccine or components and, to date, no COVID-19 vaccine manufactured at this plant has been distributed for use in the U.S.,” – comment FDA.
The FDA’s Inspections And COVID-19 Vaccines Safety
The FDA’s inspections are thorough, and these assessments review the quality of manufacturing procedures, including records, staff training, facility operations, drug production and testing and the systems in place to ensure product quality. During an inspection of Emergent BioSolutions that ended Tuesday, the FDA cited a number of observations concerning whether the facility’s processes met our requirements and standards. These observations are outlined in the inspection closeout report, also known as a “FDA Form 483.”
The FDA Form 483 notifies the company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.
“The FDA’s observations are intended to identify certain conditions observed during an inspection that have the potential to lead to quality issues during the manufacturing of a product. Once we observe such conditions, we can then work with a company to help identify a path forward to remedy the issues,” – the FDA said.
Emergent BioSolutions Investigation
It is often in the public’s best interest that the FDA work with firms to quickly resolve compliance matters to ensure that the public has access to medical products that meet the agency’s high standards for quality, safety and effectiveness.
In the case of Emergent BioSolutions, the FDA are working with the company to address the conditions identified. At the agency’s request, Emergent BioSolutions has agreed to pause new production while it works with the FDA to resolve potential quality issues. For the vaccines already manufactured, the products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distribution. “We will not allow the release of any product until we feel confident that it meets our expectations for quality,” – Acting commissioner of Food and Drugs – Food and Drug Administration, Janet Woodcock M.D. and director – Center for Biologics Evaluation and Research (CBER) Peter Marks M.D., PhD., said.
These actions are unrelated to an ongoing evaluation by the FDA and U.S. Centers for Disease Control and Prevention of extremely rare cases of a specific type of blood clot reported in a very small number of individuals after receiving the Johnson & Johnson COVID-19 Vaccine.
