FDA Boosts Johnson & Johnson’s COVID-19 Vaccine for Export

FDA recently updated its letter of authorization for Johnson & Johnson’s COVID-19 vaccine to help facilitate potential export to other countries. 

Under the revised letter, FDA authorized for use two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore. The distribution and administration of exported vaccines must follow the laws of the recipient countries. 

Prior to the authorization, the agency conducted a thorough review of results of quality testing performed by the manufacturer and determined that these batches were suitable for use during the coronavirus public health emergency.

FDA’s decision to include these two batches in the authorization means that the vaccine can be used in the US or exported to other countries. 

Notably, one condition of the updated authorization is that FDA may share relevant information about the manufacture of the batches under an appropriate confidentiality agreement with regulatory authorities of the countries in which the vaccine may be used.

The agency has not yet decided whether Emergent BioSolutions can reopen the factory, which has been closed for two months because of regulatory concerns.

“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,” Peter Marks, MD, PhD, said in the letter of authorization update. 

“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,” Marks continued. 

According to NBC News, FDA told Johnson & Johnson to discard nearly 60 billion doses of its vaccine at the Baltimore plant after the doses were found to be “not suitable for use.” But 

additional batches are still under review and the agency will keep the public informed as those reviews are completed. 

In April, the Biden Administration appointed Johnson & Johnson to lead COVID-19 vaccine production at the Baltimore manufacturing plant, which had contaminated 15 million doses of the company’s vaccine.

At the time, Emergent BioSolutions, a contract manufacturer that has been manufacturing both the Johnson & Johnson and AstraZeneca vaccines, mixed up ingredients from the two.