J&J COVID-19 Vaccines Authorized for Worldwide Deployment
The U.S. Food and Drug Administration (FDA) confirmed it is taking action to supply the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made available in the USA and globally.
On June 11, 2021, the FDA announced that it is authorizing for use under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, two batches of vaccine drug substance previously manufactured at the Emergent BioSolutions facility in Baltimore, MD.
Before making this decision, the FDA stated it ‘conducted a thorough review of facility records and the manufacturer’s quality testing results. Based on this review and considering the current COVID-19 public health emergency, the FDA concluded these batches are suitable for use.’
While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management.’
A condition on any export of these batches, or of vaccine manufactured from these batches, is that Janssen and Emergent agree that the FDA may share relevant information about the manufacture of the batches under an appropriate confidentiality agreement with the regulatory authorities of the countries in which the vaccine may be used.
The FDA has also revised the letter of authorization for the Janssen vaccine to help facilitate export to other countries. Under the revised letter of authorization, the distribution and administration of exported vaccines must comply with the laws of the recipient countries.
The FDA has determined several other batches are not suitable for use. However, additional batches are still under review, and the agency will keep the public informed as those reviews are completed.
“These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product. This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s current good manufacturing practice requirements,” commented Peter Marks, M.D. Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a related press statement.
Based in Maryland, the FDA is an agency within the U.S. Department of Health and Human Services.
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