J&J says U.S. FDA agrees to extend shelf life of its COVID-19 vaccine

he U.S. Food & Drug Administration extended the shelf life for Johnson & Johnson’s (JNJ.N) single-shot COVID-19 vaccine to six months from four-and-a-half months, the company said late Wednesday.

The FDA’s decision is based on data from ongoing studies, which showed the vaccine is stable at six months when refrigerated at 2 to 8 degrees Celsius (36–46 degrees Fahrenheit), the drugmaker said. (https://bit.ly/3ypgpTT)

In a letter to the company, the FDA said it had completed the review of data provided by J&J, and based on the information submitted, it concurs with the extension. (https://bit.ly/3zRuTMB)

The agency also said the extension was applicable to batches that might have expired prior to the issuance of the letter provided they were stored at the recommended temperature.