The Department of Health and Human Services has announced that healthcare providers will be able to administer monkeypox vaccines in a way that would increase the limited supply of doses fivefold as part of an effort to accelerate the response to the worsening outbreak.
To combat shortages, the Biden administration will allow healthcare providers to stretch out limited doses of the Jynneos vaccine, which works both pre-exposure to the monkeypox virus and can also lessen the severity of illness post-exposure. The FDA will allow the shots to be administered using one-fifth of the current dose into the top layer of the skin instead of a full dose into the fat underneath the skin.
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“Today’s action will allow FDA to exercise additional authorities that may increase availability of vaccines to prevent monkeypox while continuing to ensure the vaccine meets high standards for safety, effectiveness, and manufacturing quality,” said HHS Secretary Xavier Becerra.
But the revised method of giving the shots will require new supplies as well as training. The Centers for Disease Control and Prevention will oversee an outreach and education program for healthcare providers who may not be as familiar with intradermal administration.
The method known as “dose-sparing” does not sacrifice safety, the administration officials said Tuesday. The immunological response to the vaccine administered intradermally was equivalent to the response spurred when the shot was given subcutaneously. The effectiveness of the vaccine, which was initially approved for smallpox but can be repurposed for monkeypox, is still being evaluated. The CDC has been developing “a portfolio of vaccine effectiveness projects that we will identify data from various locales, populations and time points,” according to Director Rochelle Walensky.
“I do want to reiterate that while additional vaccine effectiveness studies are underway, we at CDC are very much recommending that people who get vaccinated continue to take steps to protect themselves from infection, especially if they have only had a single dose, by avoiding close skin to skin contact, including intimate contact with somebody who has monkeypox, because we don’t yet know how well these vaccines work,” Walensky said.
Becerra declared monkeypox a public health emergency last week, a designation meant to drive awareness of symptoms to look out for, as well as to unlock additional funding to deal with the outbreak.
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The move to use just a fifth of the vaccine vials would free up about 2 million more doses, the demand for which has outpaced supply. While the Biden administration has scaled up the procurement and distribution of Jynneos vaccines in recent months, it’s not enough. Nearly 800,000 doses were just made available from the vaccine manufacturer’s plant in Denmark. The administration also purchased roughly 5 million more doses to be delivered by mid-2023. The United States has so far made 1.1 million doses of vaccine available to states, and about 670,000 doses have been delivered, a drop in the bucket relative to the number of people who could benefit from them.
Nearly 9,000 cases of monkeypox across all but one state have been reported in the U.S. since mid-May, when the first cases were detected in Europe. The disease is typically not fatal, and no deaths have been reported in the U.S., but the disease is very painful. Infection typically causes flu-like symptoms as well as pustules and lesions on the skin of the arms, hands, feet, face, and inside the mouth. The recent outbreak is unusual in that lesions have been detected most often in the genital region among men who have sex with men. Its resemblance in these cases to sexually transmitted diseases has made it difficult for healthcare providers to diagnose infection accurately.
