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J&J vaccine shelf life gets FDA extension

Doses stable 6 more weeks, firm says by NOAH WEILAND THE NEW YORK TIMES | June 11, 2021 at 3:57 a.m.

The Food and Drug Administration on Thursday authorized an extension of the expiration date of Johnson & Johnson's coronavirus vaccine, the company said in a statement, expanding the shelf life by six weeks shortly before millions of doses were set to possibly go to waste.

"The decision 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 36-46 degrees Fahrenheit," Johnson & Johnson said in a statement.

The move gives states extra time to figure out how to use up their supply of the single-dose vaccine, even as local officials have struggled to use up stockpiles of the vaccine, which has lately faced sagging demand. Since it was authorized by the FDA in late February, it has been a critical resource in reaching more isolated communities and people who prefer to receive just one shot.

But the vaccine took a major hit in April when the FDA and Centers for Disease Control and Prevention recommended a pause in its use after a rare blood-clotting disorder occurred in some recipients of the vaccine.

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State officials have said that decision significantly curtailed interest in the vaccine, and roughly 10 million doses delivered to states remain unused, according to data collected by the CDC. The pace of vaccinations has fallen in recent weeks for all three federally authorized vaccines, and the Biden administration has shifted its strategy from relying on mass vaccination sites to highlighting more targeted approaches, some with incentives.

Dr. Marcus Plescia, who represents state health agencies as the chief medical officer for the Association of State and Territorial Health Officials, said last week that he believed every state was facing looming expiration dates on the vaccine, prompting local officials to search for ways to exhaust even their limited supply of it.

Gov. Mike DeWine of Ohio on Monday pleaded with health providers in his state to use about 200,000 doses of the vaccine that he said were set to expire on June 23. The state's health department directed providers to adopt a "first-in, first-out" process for the shot to ensure doses with earlier expiration dates were used first.

Officials across the South, where vaccination rates have lagged, have also been searching for ways to use up tens of thousands of doses in their possession. In Arkansas, officials are hoping to use as much as they can at weekend pop-up clinics, including on Juneteenth, said Dr. Jose Romero, the Arkansas health secretary.

Dr. Clay Marsh, West Virginia's coronavirus czar, said Thursday that the state had ample supply of the three vaccines, giving residents plenty of choice among the shots from Pfizer-BioNTech, Moderna and Johnson & Johnson. But he said the extension could breathe some life into his state's efforts to continue reaching vulnerable people: those with disabilities, those who are homebound or homeless, and those with some kind of social instability.

He added that the single-shot vaccine still appealed to people wary of two doses of a vaccine, and that West Virginia was looking to offer Johnson & Johnson's vaccine at summer fairs and festivals, and in parks. Around 25,000 doses there had been due to expire this month, he said.

"The J&J vaccine in those settings is, I think, highly preferable," he said.

Marsh said he was still wary of having excess doses, even with an extended shelf life, and that the state was talking to the federal government about how to possibly give them away in time.

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