J&J says U.S. FDA agrees to extend shelf life of its COVID-19 vaccine
The U.S. Food & Drug Administration extended the shelf life for Johnson & Johnson’s 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.
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.
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.
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