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FDA Solves Problem of Expiring Vaccines

Doses will be considered good for 4.5 months now, up from 3
By Bob Cronin,  Newser Staff
Posted Jun 10, 2021 5:10 PM CDT

(Newser) – State health officials have been nervous about hundreds of thousands of doses of Johnson & Johnson coronavirus vaccine scheduled to expire in June. It's not an issue anymore. The Food and Drug Administration told the company Thursday to consider the shelf life of the product to be 4½ months, up from the three months everyone has been following till now, Axios reports. So the doses in question will be good into July. The revised viability only appears to be arbitrary. Johnson & Johnson said the change is based on "data from ongoing stability assessment studies, which have demonstrated that the vaccine is stable at 4.5 months when refrigerated at temperatures of 36 to 46 degrees." The vaccine can be stored at higher temperatures than the Pfizer and Moderna versions, and it requires only one shot.

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A former FDA commissioner who's on the Johnson & Johnson board said it's not known how long the vaccine is good. "The J&J vaccine is one you can refrigerate for a long time but as part of this emergency, we weren't able to take the time to see just how long they could last," Dr. Mark McClellan told CNN. Ongoing studies could still provide the answer. The nearing expirations highlight the slowdown in vaccine distribution. CDC data show more than 10.1 million Johnson & Johnson doses have been delivered but not given to anyone. States with more than they need, or whose stock is about to expire, could share with other states, but officials said that's complicated. And sharing with other nations is even more complicated—and essentially not possible now. (Read more Johnson & Johnson stories.)

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