The U.S. Food and Drug Administration (FDA) has authorized a second extension of the shelf life for the Johnson & Johnson (Janssen) COVID-19 vaccine by 45 days from 4½ months to six months.
This decision is based on data from ongoing stability assessment studies show that the vaccine remains safe and effective for administration at least six months when refrigerated at temperatures of 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius), according to Johnson & Johnson.
COVID-19 vaccines with an emergency use authorization do not have fixed expiration dates, and the dates can be extended as more stability data is received and analyzed, according to the FDA. In June, the FDA first extended the vaccine’s shelf life by six weeks from three months (90 days) to 4½ months (135 days). Upon further study, the FDA granted a second extension July 28.
The FDA’s announcement gives vaccine providers six more weeks to administer doses that were originally set to expire in August. For example, any doses in unopened, unpunctured vials that were set to expire on Saturday, August 7, will be viable until Tuesday, September 21, provided they have been consistently refrigerated at appropriate temperatures.
The shelf-life extension is applicable to vials that expired prior to this announcement, as long as the vials were unopened and unpunctured, and those vials were stored as recommended, according to a letter the FDA sent to Johnson & Johnson on July 28. Vaccine providers should confirm the new expiration date before administration. Johnson & Johnson officials said in a news release the company is in the process of updating those expiration dates, available through its website search.
The Johnson & Johnson COVID-19 vaccine vials and cartons do not contain a printed expiration date. The FDA advises vaccine providers to check the manufacturer’s website to obtain the most up-to-date expiration dates for COVID-19 vaccines in storage. Vaccine providers will be able to enter the vaccine lot number into the Johnson & Johnson Expiry Checker website or by phone using an automated response system at 1.800.565.4008. This process should take less than one minute to complete.
Please visit the Janssen website for vaccine providers for step-by-step instructions on how to obtain the expiration date. With every new lot, obtain the expiration date prior to the first patient administration. Continue to follow a “first-in-first-out” approach to use the oldest vaccine doses first. Prior to discarding any doses, please confirm the expiration date. Expired vaccine should be removed immediately from storage units that contain viable vaccine to avoid inadvertently administering those doses. Discard/return unused doses according to state and federal regulations.