FDA extends expiration date on Johnson & Johnson COVID-19 vaccine, saving doses from destruction
The Food and Drug Administration on Thursday extended the expiration date on hundreds of thousands of doses of Johnson & Johnson's COVID-19 vaccine that otherwise would have expired within the next month, requiring them to be discarded.
The FDA authorization extends the shelf life for the J&J vaccines from three months to four-and-a-half months, the company said in a news release.
The extension is based on ongoing vaccine stability assessment studies that demonstrated the one-shot vaccine remains stable and protective for 18 weeks when refrigerated at 36 to 46 degrees.
The news will be welcome in states faced with the prospect of discarding doses of the J&J vaccine when they reached their expiration date – many on June 24.
Slowing demand and the lingering effects of an 11-day pause on the J&J vaccine meant states were having trouble finding willing arms.
"When we had more demand than the supply could meet, expiration dates weren't a problem. Vaccine was being used up as fast as it came in the door," said Dr. Kelly Moore, deputy director of the Immunization Action Coalition.
That changed in the past month.
As of Wednesday in Arkansas, there were 93,271 doses of unadministered J&J vaccine. Of those, 42,971 were set to expire on June 23 and 10,042 on July 4, the Arkansas Department of Health said.
In Iowa, 33,000 doses of the vaccine were on the verge of expiring, the state Department of Public Health said Wednesday.
In Ohio, the governor warned 200,000 J&J doses would have to be tossed June 24 if they don't get takers.
In Arizona, as many as 100,000 doses with the June 23 expiration date hadn't found people to use them. Other states reported soon-to-expire doses as well.
"You've got three choices," said John Grabenstein, a former Merck executive and former director of a Department of Defense military immunization program. "You increase demand and use the doses up, you extend the expiration date, or you throw them away."
J&J vaccine demand trails Pfizer-BioNTech and Moderna
Increasing demand has been difficult. Almost 52% of people in the USA have received at least one COVID-19 shot, but vaccination rates are falling to new lows.
Twelve states have seen vaccinations sink to 15 daily shots per 10,000 residents; Alabama had just four people per 10,000 residents get vaccinated last week,
On top of that, confidence in the J&J vaccine plummeted after the Food and Drug Administration and the Centers for Disease Control and Prevention paused the administration of the vaccine April 13, when a small number of cases of a rare blood-clotting disorder were associated with the shot.
The pause was lifted after 11 days when an investigation showed that out of nearly 8 million who received the vaccine, 15 people had developed the condition, and three had died.
Demand for the J&J shot is lower than for the Pfizer/BioNTech or Moderna vaccines, despite being "one and done."
The vaccine was authorized Feb. 27, and production ramped up in April. That came just as the pause was initiated, leading to increasing supplies even as demand sank.
Vaccine produced in April would have begun to expire in June.
CDC data this week shows about 10 million doses of J&J vaccine have yet to be administered, about half of the doses delivered. When those doses might reach their expiration dates isn't known.
Extending the shelf life requires extensive testing and FDA approval, a process J&J and FDA have been engaged in since the vaccine was approved.
As they're manufactured, vials of vaccine are put aside for stability testing to determine how long they stay potent, Grabenstein said.
"Every month, you test five or 10 vials and see how they do," he said. The numbers are reported to the FDA, which can extend the shelf life if warranted. "A vaccine approved 10 years ago might have started with a 12-month stability at first, and then, over time, testing might extend that two years."
'You're not allowed to guess about expiration dates'
When J&J first presented its data to the FDA's Vaccines and Related Biological Products Advisory Committee on Feb. 26, the vaccine had a shelf life of three months when refrigerated at 36 to 46 degrees. It remained stable for two years when frozen at minus 4 degrees.
Each vial of vaccine is shipped with a code that can be entered into a website, which will tell when the vial expires. That is being updated.
Even expired, the J&J doses aren't necessarily ineffective, Moore said, but without the data, they couldn't be used.
"You're not allowed to guess about expiration dates," she said.
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Any vaccine that isn't used by its expiration date must be disposed of properly, which means a process of "controlled destruction" such as incineration.
"You don't want this stuff to get diverted so that substandard or counterfeit vaccine could be sold to unsuspecting people," Grabenstein said.
Some public health officials hoped more creative answers could be found in the two weeks that remained for some of the doses.
William Humble, executive director of the Arizona Public Health Association, hoped Arizona could find a way to get its unused vaccine to people in Mexico across the border, where the J&J vaccine is authorized but little is available.
The Arizona Department of Health Services does have vaccination options near the border that don't require proof of citizenship, and the state participates in the federal vaccine pool, which is where vaccines to be donated internationally will come from, spokesman Steve Elliott said.
Humble suggested a big push to make sure every last dose gets used before it reaches its expiration date.
"If we even did big mass vaccination clinics in Nogales, Arizona, where people could walk across the border, you could probably give tens of thousands of vaccine doses if you did a several-day event," he said. “That would be a creative way of not wasting it."