The U.S. Food and Drug Administration (FDA) on March 4 authorized a shelf-life extension, from six to nine months, for the Janssen COVID-19 vaccine produced by Johnson & Johnson.
The concurrence letter is posted on FDA’s website and explains that the extension now applies “to all refrigerated vials of Janssen COVID-19 Vaccine that have been held in accordance with the manufacturer’s storage conditions,” at 2-8 degrees Celsius.
“This extension was granted following a thorough review of data submitted by Janssen,” according to the FDA.
The extension is based on the FDA’s review of data submitted by Janssen and “applies to all batches that have been released to the US market.”
The concurrence letter, addressed to the manufacturers, notes that “any changes that you (Janssen Biotech) plan to implement to the description of the product, manufacturing process, facilities, or equipment, will need to be submitted as an amendment to the EUA and not implemented without concurrence by the Agency”.
