FDA extends Johnson & Johnson vaccine shelf life

FDA extends Johnson & Johnson vaccine shelf life
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The Food and Drug Administration (FDA) extended the Johnson & Johnson COVID-19 vaccine’s shelf life on Wednesday to six months amid state officials’ concerns of expiring doses.

The federal agency approved an amendment to Johnson & Johnson’s emergency use authorization to allow its single-dose vaccine to be stored at normal refrigeration temperatures of 36 to 46 degrees Fahrenheit for half a year. 

Before the update, the vaccine was set to expire after 4 1/2 months. 

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The FDA cited company data in its decision, saying in a letter that the change was “applicable to batches that might have expired prior to the issuance” of the amendment as long as the doses had been stored at the correct temperatures. 

Johnson & Johnson noted in a press release that the agency’s authorization for longer storage time is “based on data from ongoing stability assessment studies.”

The shelf life of the single-dose vaccine was previously extended in June from three months to 4 1/2 months. 

More than 13.1 million Americans have been fully vaccinated with the Johnson & Johnson vaccine, much less than the 87.2 million and the nearly 63.2 million fully vaccinated with the Pfizer-BioNTech and Moderna vaccines, respectively.

The Johnson & Johnson shot was granted emergency use authorization in February, months after the other two vaccines. The vaccine also underwent a temporary pause in April as health officials examined cases of very rare blood clots. 

With only one dose and the ability to be stored at regular refrigerator temperatures, experts have also viewed the shot as a way to vaccinate people in hard-to-reach areas.