WATCH: White House monkeypox response team says US will expand vaccine supply with smaller doses

US health officials on Tuesday approved a plan to increase the nation’s limited supply of monkeypox vaccine by giving people only one-fifth of the usual dose, citing research suggesting a reduced amount is effective.

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The so-called dose-sparing approach also calls for the Jynneos vaccine to be given by injection directly under the skin rather than into the deep tissue — a practice that may better speed up the immune system. Recipients will still get two shots four weeks apart.

The highly unusual move is a stark admission that the United States currently lacks the supplies to vaccinate everyone seeking protection from the fast-spreading virus.

This includes 1.6 million to 1.7 million Americans who federal officials consider to be most at risk of contracting the disease, especially men with HIV or men who have a higher risk of contracting it. It would require more than 3.2 million injections to be vaccinated for that group.

White House officials said the new policy would immediately double the 440,000 currently available in full doses to more than 2 million smaller doses.

“It’s safe and effective and will greatly increase the volume of vaccine doses available to communities across the country,” Robert Fenton, the White House monkeypox response coordinator, told reporters.

The Biden administration declared monkeypox a public health emergency last week in an effort to slow the growing outbreak of the disease that has infected more than 8,900 Americans. Officials announced a separate decision Tuesday that allows the Food and Drug Administration to expedite its review of medicinal products or new uses for them, such as Jynneos’ own dose-reduction technology.

Read more: What are the symptoms of monkeypox? Here’s what you need to know

The US Food and Drug Administration (FDA) has approved the new approach for adults age 18 and older who are at risk of developing monkeypox infection. The agency said that younger people can also get the vaccine if they are considered to be at high risk, although they should receive the traditional injection.

FDA officials stressed that a second dose is necessary to ensure protection.

Dr. said. Peter Marks, chief of the Food and Drug Administration’s Vaccine.

The regulators cited a 2015 study showing that vaccination with one-fifth of the conventional two-dose vaccine elicited a robust immune system response similar to that of the full dose. About 94 percent of people receiving a smaller dose had adequate levels of anti-virus antibodies, compared to 98 percent of those receiving the full dose, according to the study funded by the National Institutes of Health.

The National Institutes of Health plans to further trial this technology in the coming months. Rochelle Wallinsky, director of the Centers for Disease Control and Prevention, said her agency has already begun tracking real-world efficacy in American communities, although initial estimates will take time.

But some experts and advocates worry that the lack of data to support the policy may backfire if it reduces the effectiveness of the vaccine.

Said David Harvey of the National Coalition of STD Managers, with the current situation.

Smaller doses also require a different type of injection that only penetrates the top layer of the skin, rather than the bottom layer between the skin and muscle. This is a less common technique and may require training for some health practitioners. It is also associated with more side effects such as redness, itching, and swelling.

Superficial injections are thought to help stimulate the immune system because the skin contains many immune cells that target external invaders.

Watch: How a new national emergency declaration could slow the spread of monkeypox

The CDC will provide educational materials on this technology along with a broader awareness campaign for US health departments.

Rationalization of vaccine doses is common in Africa and other parts of the world with limited health resources. In recent years, the World Health Organization has endorsed an approach to address outbreaks of yellow fever, polio, and other diseases.

Dr. said. William Moss of the Johns Hopkins Vaccine Access Center. “It’s about public health decision making: In the midst of an outbreak where you have insufficient supplies, are you making that trade-off?”

Both the United Kingdom and Canada have adopted a single-dose vaccination strategy that prioritizes people at the highest risk of developing monkeypox. Health departments in several major US cities have adopted a similar strategy amid tight supplies, including New York, San Francisco and Washington.

US officials have shipped more than 617,000 full doses of vaccine to state and local health departments. So far, the shots have been recommended for people who have already been exposed to monkeypox or are likely to contract it due to recent sexual contact in areas where the virus is common.

The Biden administration has been criticized for not mobilizing millions of additional doses from the country’s Strategic National Stockpile. Officials have ordered 5 million injections since July, but most are not expected to be delivered until 2023. Under the new dosing strategy that would account for 25 million doses.

The US government owns vaccine ingredients in large quantities equivalent to 16.1 million doses under contracts with the Danish-Bavarian manufacturer Nordic. But the material must be sealed in vials, a process that is expected to take months as the small business orders from other countries.

The U.S. Food and Drug Administration approved the Jynneos vaccine in 2019 to prevent smallpox and monkeypox based in part on studies in monkeys. Animals who received the two-dose vaccination were more than twice as likely to survive than those who did not have monkeypox infection, according to the U.S. Food and Drug Administration’s classification.

Additional human studies showed that people who received Genio had a similar immune response to those who received an older smallpox vaccine. But Jynneos has not been tested on humans with monkeypox or the relative smallpox, which were eradicated decades ago.

The Associated Press’s Department of Health and Science receives support from the Howard Hughes Medical Institute’s Division of Science Education. AP is solely responsible for all content.

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