The FDA announced Friday that batches of Johnson & Johnson COVID-19 vaccine manufactured at Emergent BioSolutions’ beleaguered facility will be authorized under emergency use authorization (EUA) for use.
However, in a highly unusual move, the agency said it is only authorizing the vaccine batches under EUA, not the manufacturing facility itself.
In order to fill a “critically needed supply” of Johnson & Johnson COVID-19 vaccine, the FDA said it is authorizing two batches of “vaccine drug substance” manufactured at the Emergent BioSolutions plant in Baltimore. While the agency characterized the batches as “suitable for use,” it added, “the FDA is not yet ready to include the Emergent BioSolutions plant in the [Johnson & Johnson] EUA as an authorized manufacturing facility.”
According to the New York Times, the FDA told Emergent that 60 million batches of vaccine cannot be used, and only 10 million doses can be kept. The company recently came under fire from Congress about its spoiled doses.
In its statement, the FDA said “additional [vaccine] batches are still under review.”
These authorized batches can either be used in the U.S. or sent to other countries, and the FDA said it revised the authorization of the Johnson & Johnson vaccine to ensure that distribution and administration of these vaccines are in line with the recipient countries’ laws.
Separately, following additional information from Johnson & Johnson, the agency said it will also extend the vaccine’s expiration dating to 4.5 months from 3 months when kept at 2 to 8º C.
“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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.
The agency said it is continuing to work through issues with Johnson & Johnson and Emergent BioSolutions management.