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Friday, October 1, 2021

FDA won't extend shelf life of J&J Covid vax, may extend life of Moderna shots

 The government will not extend the shelf life of hundreds of thousands of unused Johnson & Johnson Covid vaccine doses, but may soon extend the life of millions of Moderna vaccine doses, according to an internal email obtained by NBC News.

In an email sent to state health officials and health-care providers Friday morning, the Centers for Disease Control said the Food and Drug Administration will not further extend the life of Johnson & Johnson vaccines sitting on states' shelves across the country, leading to the potential waste of hundreds of thousands of doses.

The CDC told officials and health-care providers to check their Covid vaccine inventories for "many lots" of expiring Johnson & Johnson vaccine doses and told them that despite previous shelf-life extensions for Johnson & Johnson doses, the FDA will not take further action.

The email says, "There will be no more extension."

In the same message, the CDC notified states that the FDA will likely extend the expiration date of millions of doses of Moderna vaccine. Two sources who did not want to be identified told NBC News that an extension for Moderna would likely add up to two months to the life of vaccine doses.

The FDA referred inquiries to the companies and declined comment on the email. Moderna declined to comment. Johnson & Johnson did not immediately respond to a request for comment.

On July 28, the FDA extended the shelf life of the J&J doses to six months from manufacture. Doses have been rolling out to states in batches since the vaccine was approved in late February. Unused doses sent to states in April or earlier should expire soon.

It's unclear how many J&J doses could be wasted but the federal government has shipped 22 million doses to states and only 15 million have been administered so far, according to data from the CDC's website.

West Virginia Covid czar Dr. Clay Marsh said the state had recently disposed of 9,000 J&J doses. Virginia health officials told NBC News they had 26,936 J&J doses on the shelves, and Washington state had 57,883 doses as of Sept. 27. Arkansas has 11,284, Rhode Island has 6,825 as of this morning according to state officials.

Most states stopped ordering new J&J shots a few months ago and demand for the shot has not been strong, according to state health officials.

It's possible that doses on the shelves could be used as booster shots but only if the company files for authorization quickly and the FDA takes action by providing emergency use authorization for a J&J booster.

As of Sept. 21, Johnson & Johnson said it had provided all available booster data to the FDA but a formal filing has still not happened. In order for the booster approval to happen, the company would have to file, FDA officials would have to review the data and the CDC advisory committee would need to meet to weigh in.

Late Friday afternoon, the FDA announced an agency advisory committee would meet in mid-October to discuss boosters for both the J&J and Moderna vaccines.

https://www.nbcnews.com/health/health-news/fda-won-t-extend-shelf-life-j-j-covid-vaccine-n1280579

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