Feds propose new dosing strategy for monkeypox vaccine: Shots

The monkeypox epidemic is growing in the United States and vaccines remain rare.

Patrick Semansky/AP

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Patrick Semansky/AP

The monkeypox epidemic is growing in the United States and vaccines remain rare.

Patrick Semansky/AP

With the monkeypox vaccine still in short supply, the Biden administration is changing how the vaccine is administered to expand its limited number of doses.

On Tuesday afternoon, federal health officials announced their decision to allow the JYNNEOS vaccine to be administered between the layers of skin — known as an intradermal injection — rather than into the fat as is currently done. .

By delivering the injections in this way, only one-fifth of the full dose is needed for each person.

To effect the change, the Food and Drug Administration issued an Emergency Use Authorization to authorize the new dosage and the vaccine injection strategy. (This follows the decision last week by the U.S. Department of Health and Human Services to declare monkeypox a public health emergency, and an additional statement today.)

“Over the past few weeks, the monkeypox virus has continued to spread at a rate that has made it clear that our current vaccine supply will not meet current demand,” said FDA Commissioner Dr. Robert M. Califf. “This will increase the total number of doses available for use up to five times.”

Even with the switch, a person will still need to receive two doses of the vaccine.

The FDA clearance also allows those under 18 considered to be at high risk for monkeypox infection to get vaccinated. However, this population will still receive the vaccine by subcutaneous injection – not the alternative method of injection between layers of skin.

About 1.6 to 1.7 million people in the United States are considered most at risk of contracting the disease, but only about 1.1 million vaccine doses were made available, due to expiring vaccine supplies and delays in ordering replacements. Of those doses, about 670,000 have already been shipped to states and other jurisdictions.

Under the new dosing plan, the remaining 400,000 vaccine vials “will have the potential to deliver up to 2 million doses to Americans,” said Robert Fenton, White House monkeypox response coordinator.

The skin is home to a number of immune cells that trigger a potentially better immune response and this approach has been used with other vaccines, said Dr. Jon Andrus, an infectious disease specialist at George Washington University.

“It’s actually a very good technique and it makes sense going forward,” he said.

But it also presents challenges: it is more difficult to administer a vaccine between the layers of skin and requires special training. Although this method has worked for poliomyelitis and yellow fever, the evidence that it will work for monkeypox is based on a single 2015 study.

Federal health officials acknowledge that there are still questions about the effectiveness of the monkeypox vaccine.

“There is no traditional evaluation of this vaccine,” Califf said, adding that the vaccine was approved based on its “immunological response, not clinical findings.”

So far there have been approximately 9,000 confirmed cases of monkeypox in the United States, and that’s likely an undercount given the ongoing testing challenges.

“Right now, we need a lot of vaccines in a very short period of time if we are going to come face to face with this virus,” said Anne Rimoin, epidemiologist at UCLA. “And these vaccines are probably going to be very effective.”

During this current epidemic, the vast majority of cases in the United States are occurring in gay and gay sex networks, primarily among men who have sex with men.

Monkeypox causes lesions on the skin or mucous membranes. When lesions rub against another person’s skin or mucous membranes, the virus can be transmitted, especially if uninfected skin is damaged or broken. Most cases in the United States have been traced to sexual contact between men, according to the latest data from the Centers for Disease Control and Prevention.

It is possible that monkeypox is transmitted non-sexually: people can catch the virus during face-to-face interactions with someone via respiratory droplets or by touching a surface that has been contaminated. But the data from this epidemic shows that these transmission routes are extremely rare in public places. When they do occur, it most likely happens when you live with an infected person and have prolonged contact with them.

“Gay, bisexual and other men who have sex with men in recent history have demonstrated significant confidence in vaccines, with COVID vaccination rates well over 90%,” said Dr Demetre Daskalakis. , director of the HIV/AIDS Division and the deputy coordinator of the White House monkeypox response. “I think we’re going to see that we’ll probably still run out of vaccines before we run out of weapons.”

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