FDA Approval of Johnson & Johnson COVID-19 Vaccine Shelf-Life Extension

June 14, 2021

Johnson & Johnson announced that the Food and Drug Administration (FDA) has authorized an extension of the shelf life for its single-shot COVID-19 vaccine from three months to 4.5 months. The FDA issued a concurrence letter noting that Johnson & Johnson’s amendment provides information and data to support extending the vaccine shelf life. The FDA’s decision is based on stability assessment studies that demonstrated that the vaccine is stable for 4.5 months when refrigerated at temperatures of 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius).

Johnson & Johnson noted that expiration dates will be updated on and encourages vaccine providers to visit the site and confirm the latest expiration dates for their Johnson & Johnson vaccine inventory.

GNYHA will share any additional information on this as it becomes available.