F.D.A. Extends Shelf Life of J.&J. Shots by Six Weeks

F.D.A. Extends Shelf Life of J.&J. Shots by Six Weeks

2021-06-10 18:14:01

The Food and Drug Administration on Thursday approved an expiration date extension of Johnson & Johnson's coronavirus vaccine, the company said in a statement, extending its shelf life by six weeks shortly before millions of doses could potentially be lost.

"The decision is based on data from ongoing stability assessment studies, which have shown that the vaccine is stable after 4.5 months when refrigerated at temperatures of 36-46 degrees Fahrenheit," Johnson & Johnson said in a statement.

The move gives states additional time to figure out how to use up the stock of the single-dose vaccine, even as local officials have struggled to use up stocks of the injection, which have recently faced a declining demand. Since it was approved by the F.D.A. in late February, it was a critical resource in reaching more isolated communities and people who prefer to get just one shot. But about ten million doses delivered to states go unused, according to data collected by the Centers for Disease Control and Prevention.

As the rate of vaccinations has fallen in recent weeks, the extra time may not lead to a significant increase in the use of Johnson & Johnson's injection. The vaccine took a big hit in April when the F.D.A. and CDC recommended discontinuing its use after a rare blood clotting disorder occurred in vaccine recipients. State officials have said this decision has significantly curtailed interest in the vaccine.

dr. Marcus Plescia, who represents the state's health authorities as the chief medical officer of the Association of State and Territorial Health Officials, said last week that he believed every state was facing impending vaccine expiration dates, prompting local officials to to look for ways to exhaust even their limited stock of it.

Ohio Governor Mike DeWine on Monday pleaded with health care providers in his state to use about 200,000 doses of the vaccine that he said would expire on June 23. The state's health department instructed suppliers to implement a "first-in, first-out" process for the injection to ensure doses with earlier expiration dates were used first.

Officials in the South, where vaccination rates have lagged, have also looked for ways to use up tens of thousands of doses in their possession. In Arkansas, officials hope to use pop-up clinics on weekends as much as possible, including on Juneteenth, said Dr. José R. Romero, the Arkansas Secretary of Health.

dr. Clay Marsh, the coronavirus czar of West Virginia, said on Thursday the state had adequate supplies of all three federally authorized vaccines, giving residents plenty of choice. But he said the extension could breathe some life into his state's efforts to continue reaching out to vulnerable people: those with disabilities, those who are house-bound or homeless, and those with some sort of social instability.

He added that the injection still appealed to those wary of two doses of a vaccine, and that West Virginia wanted to offer Johnson & Johnson's vaccine at summer fairs and festivals and in parks. About 25,000 doses would have expired this month, he said.

"The J. & J. vaccine in those environments is, I think, highly preferred," he said.

dr. Marsh said he was still wary of having excessive doses, even with longer shelf lives, and that the state was in talks with the federal government about how to potentially give them away in time.


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