How the U.S. Let 20 Million Doses of Monkeypox Vaccine Expire
Less than a decade ago, the United States had some 20 million doses of a new smallpox vaccine — also effective against monkeypox — sitting in freezers in a national stockpile.
As the wait for a freeze-dried vaccine to be approved by the Food and Drug Administration dragged on over the last decade, the United States purchased vast quantities of raw vaccine product, which has yet to be filled into vials. “We have to prepare against multiple threats with a limited budget,” said Dr. Gary Disbrow, director of Biomedical Advanced Research and Development Authority, or BARDA, the federal agency that supported the development of Jynneos and other drugs and vaccines to protect against pandemics, bioterrorism and other hazards. “Our planning was for smallpox.”
In the years since Sept. 11, the United States stockpiled well over 100 million doses of smallpox vaccines — versions of the vaccine that eradicated the virus. With names like Dryvax and ACAM2000, they use a live virus that replicates and can have dangerous side effects, including inflammation of the heart in about six recipients out of 1,000. One or two people of every million vaccinated are expected to die.
The new vaccine, which back then went by the name Imvamune, not Jynneos, was never intended to replace the far larger stockpile of older generations of smallpox vaccines, but to be offered to those at higher risk of complications from the older vaccines and their family members, according to a 2014 report by the U.S. Department of Health and Human Services. That included people with conditions ranging from eczema to HIV, and pregnant women and infants.
As the 20 million Jynneos doses began to expire, the United States ordered another 8 million, which were shipped to the nation’s stockpile in 2015, according to Bavarian Nordic and the U.S. Health and Human Services personnel. That order was to be “a bridge” until the freeze-dried version emerged, according to a federal planning body of mainly Health and Human Services personnel.
“In fairness, I’m not sure anybody in their right mind would have thought we needed more smallpox vaccine,” said Dr. Nicole Lurie, who oversaw the stockpile during her eight-year tenure as assistant secretary for preparedness and response within Health and Human Services under President Barack Obama.
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