Slowing demand and the lingering effects of an 11-day hiatus on the Johnson & Johnson COVID-19 vaccine mean states have hundreds of thousands of doses that may expire before they can find consenting weapons.
“When we had more demand than supply could meet, expiration dates were not a problem. The vaccine was used up as quickly as it arrived,” said Dr Kelly Moore, deputy director of the Immunization Action Coalition.
That changed last month.
As of Wednesday, in Arkansas, there were 93,271 doses of unadministered J&J vaccine. Of those, 42,971 expire on June 23 and another 10,042 expire on July 4, the Arkansas Department of Health said.
In Ohio, the governor has warned that 200,000 doses of J&J will have to be thrown away on June 24 if they don’t get takeaway.
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In Arizona, up to 100,000 doses with the expiration date of June 23 have yet to find weapons. Other states have also reported near-expiration doses.
“You have three choices,” said John Grabenstein, former Merck executive and former director of the US Department of Defense military vaccination program. “You increase the demand and use the doses, you extend the expiration date or you throw them away.”
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Increasing demand has proven difficult. So far, nearly 52% of people in the United States have received at least one injection of COVID-19, but vaccination rates are now falling to new lows.
Twelve states have seen immunizations drop to 15 daily injections per 10,000 population; In Alabama, only four people per 10,000 people got 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 suspended administration of the vaccine on April 13, when a small number of cases of a disorder rare blood clotting has been associated with the stroke.
The hiatus was lifted after 11 days when an investigation showed that of nearly 8 million people who received the vaccine, only 15 people had developed the disease and three had died.
Despite this, the demand for the J&J vaccine is lower than that of the Pfizer / BioNTech or Moderna vaccines.
While the vaccine was first authorized on February 27, production increased in April. Unfortunately, this happened just as the hiatus began, leading to an increase in supply even as demand plummeted.
The vaccine produced in April will begin to expire in June, which is why so many doses are now reaching the end of their shelf life.
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CDC data this week shows that about 10 million doses of J&J vaccine were never given, or about half of the doses delivered. It is not known when these doses may reach their expiry date.
Extending shelf life requires extensive testing and FDA approval.
As they are made, the vaccine vials are set aside for stability testing to determine how long they stay active, Grabenstein said.
“Every month you test five or 10 vials and see how they work,” he said. The numbers are reported to the FDA, which can extend the shelf life if warranted.
“A vaccine approved 10 years ago could have started with a stability of 12 months at first, then over time testing could extend those two years,” he said.
“You are not allowed to guess the expiration dates”
When J&J first presented its data to the FDA’s Vaccines and Related Biologics Advisory Committee on February 26, the vaccine had a three-month shelf life when refrigerated between 36 and 46 degrees. It remained stable for two years when it was frozen at minus-4 degrees.
As more and more data is collected, the company and the FDA are examining whether the date can be extended.
Currently, each vaccine vial is shipped with a code that can be entered on the website that will indicate when the vial expires.
Even expired, J&J doses aren’t necessarily ineffective, Moore said. But without data, they cannot be used.
“You are not allowed to guess the expiration dates,” she said.
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Any vaccine that is not used before its expiration date must be disposed of properly, which means a “controlled destruction” process such as incineration.
“You don’t want these products to be diverted so that substandard or counterfeit vaccines can be sold to unsuspecting people,” Grabenstein said.
Some public health officials are hoping more creative answers can be found within the remaining two weeks for some of the doses.
William Humble, executive director of the Arizona Public Health Association, hopes Arizona can find a way to deliver its unused vaccine to people in Mexico just across the border, where the J&J vaccine is licensed but not readily available. .
The Arizona Department of Health Services has near-border vaccination options that do not require proof of citizenship, and the state participates in the federal vaccine pool, where the vaccine will come from to be donated to scale. international, said spokesman Steve Elliott.
Humble hopes for a great effort to ensure that every last dose is used up before it needs to be destroyed.
“If we even had big mass vaccination clinics in Nogales, Arizona where people could walk across the border, you could probably administer tens of thousands of doses of vaccine if you had a multi-day event,” did he declare. “It would be a creative way not to waste it.”