FDA Extends Shelf Life of Johnson & Johnson’s COVID-19 Vaccine

The Food and Drug Administration (FDA) has agreed to extend the shelf life on Johnson & Johnson’s single-shot COVID-19 vaccine from four-and-a-half months to six months.

In a July 28 concurrence letter (pdf), the FDA said Johnson & Johnson had provided sufficient data to support the extension of the company’s vaccine to six months, including for already expired batches, provided they have been stored within the required temperature range of between 36–46 degrees Fahrenheit (2–8 degrees Celsius).

Johnson & Johnson said in a statement that it is “pleased” with the FDA’s decision, adding that the pharmaceutical firm had provided the agency with data from ongoing stability assessment studies that have demonstrated the vaccine remains stable at six months if stored at the required temperature.

Health authorities in a number of states have warned that they may be forced to throw out thousands of doses of Johnson & Johnson’s vaccine absent an extension.

The FDA has been reviewing expiration dates on all three COVID-19 vaccines authorized for emergency use in the United States, as manufacturers have continued to test batches for stability following their roll-out. Pfizer and Moderna’s two-dose vaccines have a shelf life of six months.