FDA expands monkeypox vaccine authorization to increase dose supply five-fold

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 will allow health-care providers to administer the shots through intradermal injection, or between the layers of the skin, which will increase the supply of doses by as much as fivefold. The vaccine is traditionally administered through subcutaneous injection, which goes into the fat layer beneath the skin. The intradermal injections are only for adults.

The emergency authorization also allows people under age 18 to receive the vaccine if they are at high risk of monkeypox infection. People under age 18 would receive the shot through subcutaneous injection.

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.

The U.S. has struggled to keep with up demand for the shots as the monkeypox outbreak grows, which has made it difficult for people to get appointments and lead to long lines outside clinics.

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.

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.

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.

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