FDA expands monkeypox vaccine authorization to increase dose supply, allows

The Food and Drug Administration on Tuesday expanded its authorization for the monkeypox vaccine in a way that would significantly boost the limited supply of shots.

The FDA is also now allowing children to receive the vaccine if they are at high risk of monkeypox infection. Dr. Peter Marks, head of the FDA’s vaccine division, said there has been an increase in possible exposures among children over the past week.

Health-care providers can now administer the shots to adults through intradermal injection, or between the layers of the skin. This will increase the supply of doses by as much as fivefold, according to FDA. The vaccine is traditionally administered through subcutaneous injection, which goes into the fat layer beneath the skin.

Children will receive the vaccine through the typical subcutaneous injection. Marks said there isn’t enough data to allow intradermal injections for kids and this method is also difficult to administer to very young children.

Jynneos is the only FDA approved monkeypox vaccine in the U.S. The shots are administered in two doses 28 days apart. Jynneos is manufactured by Bavarian Nordic, a biotech company based in Denmark.

Demand for the shots has outstripped available supply as the monkeypox outbreak grows. People have struggled to get appointments, which book up quickly, and there have been long lines outside clinics around the country.

The U.S. is fighting the largest monkeypox outbreak in the world with nearly 9,000 cases across 49 states, Washington D.C. and Puerto Rico, according to the Centers for Disease Control and Prevention.

The intradermal injections for adults use a lower volume dosage that will allow 400,000 vials in the strategic national stockpile to provide up to 2 million shots, according to Robert Fenton, the White House monkeypox response coordinator.

HHS has made more than 1 million doses available to state and local health departments since May. More than 620,000 doses have been shipped to jurisdictions so far, according to HHS.

Monkeypox is rarely fatal and no deaths have been reported in the U.S. so far. But the virus causes lesions that can be very painful. Some patients need hospitalization to manage the pain.

Monkeypox is primarily spreading through skin-to-skin contact during sex, according to public health officials. But people can also catch the virus through close physical contact in general, such as hugging and kissing, as well as through contaminated materials such as towels or bedsheets.

Health and Human Services Secretary Xavier Becerra declared the outbreak a public health emergency last week. The U.S. last declared a public health emergency in response to Covid-19 in 2020.

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