US Gives Smaller Doses of Monkeypox Vaccine to Expand Limited Supply – National

U.S. health officials on Tuesday approved a plan to expand the country’s limited supply of monkeypox vaccine by giving people just one-fifth the usual dose, citing research that suggests the reduced amount is about that is effective.

The so-called dose-sparing approach also involves giving the Jynneos vaccine with an injection just under the skin rather than into deeper tissues — a practice that could better boost the immune system. Recipients would still get two shots four weeks apart.

The highly unusual move is a clear acknowledgment that the US currently lacks the supplies needed to vaccinate everyone seeking protection from the fast-spreading virus.

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That includes 1.6 to 1.7 million Americans considered by federal officials to be most at risk from the disease, mostly men with HIV or men at higher risk of contracting it. Vaccination of this group would require about three times more full doses than the roughly 1.1 million officials have provided.

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White House coordinator for monkeypox control Robert Fenton said the plan would help the US “stay one step ahead of the virus”.

“It’s safe, it’s effective and will significantly increase the volume of vaccine doses available to communities across the country,” Fenton told reporters.

Click here to play the video: “Dr. Fauci welcomes emergency declaration of monkeypox and considers the way forward

dr Fauci welcomes declaration of emergency over monkeypox, considers way forward

dr Fauci welcomes declaration of emergency over monkeypox, considers way forward

The Biden administration last week declared monkeypox a public health emergency to slow the growing outbreak that has infected more than 8,900 Americans. Officials on Tuesday announced a separate rule that would allow the Food and Drug Administration to expedite its review of medicinal products or new uses for them, such as: B. the dose-saving technique for Jynneos.

The FDA approved the new approach for adults 18 and older who are at high risk of monkeypox infection. Younger people can also get the vaccine if they’re classified as high risk, although they should get the traditional injection, the agency said.

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The announcement marks a reversal from last month, when the FDA and other agencies repeatedly emphasized that two full doses of the vaccine are required for adequate protection.

But regulators are now pointing to a 2015 study showing that vaccination at a fifth the traditional dose produces a robust immune system response comparable to that of the full dose. According to the National Institutes of Health-funded study, about 94% of people who received the smaller dose had adequate levels of virus-fighting antibodies, compared with 98% of people who received the full dose.

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According to the agency, the NIH is planning another attempt with the technology in the coming months.

Vaccine manufacturers often formulate their vaccines to provide more than enough protection, so it’s not uncommon that a smaller dose could still prove effective.

However, some experts and advocates warned that there is little data to support the directive and feared it could backfire if the vaccine’s effectiveness was reduced.

“We are seriously concerned about the limited amount of research that has been done on this dose and delivery method, and we worry it will give people a false sense of confidence that they are protected,” said David Harvey of the National Coalition of STD Directors , in a statement.

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White House says declaration of emergency for monkeypox will speed up vaccine distribution

White House says declaration of emergency for monkeypox will speed up vaccine distribution

The smaller doses also require a different type of injection that only penetrates the top layer of skin and not the bottom layer between the skin and muscle. This is a less common technique that may require training for some healthcare practitioners. It is also associated with more side effects like redness, itching, and swelling.

The shallower injection is believed to stimulate the immune system as the skin contains numerous immune cells that attack outside invaders.

The Centers for Disease Control and Prevention said they will provide educational materials on the technique to US public health officials along with a broader awareness campaign.

Vaccine dose rationing is common in Africa and other parts of the world with limited health resources. In recent years, the World Health Organization has endorsed the approach to combating outbreaks of yellow fever, polio and other diseases.

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“This is not an unusual situation,” said Dr. William Moss of the Johns Hopkins Vaccine Access Center. “It comes down to public health decision-making: In the midst of an outbreak where you’re undersupplied, are you making that compromise?”

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When the first COVID-19 vaccines became available in late 2020, the UK government prioritized giving a first dose to as many people as possible over providing second shots.

Both the UK and Canada have adopted a single-dose vaccine strategy, prioritizing people at highest risk of monkeypox. And public health departments in several major US cities, including New York, San Francisco and Washington, followed a similar strategy in the face of limited supplies.

US officials have shipped more than 617,000 full doses of the vaccine to state and local health authorities and plan to distribute another 380,000 in the coming weeks. Previously, it was recommended for people who have been exposed to, or are likely to be exposed to, monkeypox due to recent sexual contact in areas where the virus is spreading.

The Biden administration has come under fire for not quickly assembling millions more doses from the nation’s strategic national stockpile. Officials have ordered 5 million shots since July, but most are not expected to be delivered until 2023.

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The US government owns 16.1 million doses of vaccine ingredients under contracts with Danish manufacturer Bavarian Nordic. But the material must be sealed into vials, a process that is expected to take months as the small company takes orders from other nations.

HHS last week responded to criticism of the pace and timing of the government’s vaccination decisions.

“We’ve been thinking about how and when to use the bulk vaccine because once you remove it from the bulk, you lose years of shelf life,” a spokesman said in an emailed statement.

The FDA approved the Jynneos vaccine in 2019 for the prevention of smallpox and monkeypox based in part on studies in monkeys. Animals who received the two-dose vaccine were more than twice as likely to survive after contracting monkeypox as those who didn’t, according to FDA labeling.

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Additional human studies showed that people who received Jynneos had a similar immune response to those who received an older smallpox vaccine. But jynneos has not been tested on humans with either monkeypox or the related smallpox that was eradicated decades ago.

This is typical of many of the vaccines and drugs in the national stockpile that treat rare or deadly pathogens such as anthrax or the plague.

The US government has spent more than $1 billion developing and stockpiling the freeze-dried vaccine, which replaced an earlier liquid version with a shorter shelf life. Bavarian Nordic has a 10-year contract with the US to supply the new vaccine.

© 2022 The Canadian Press US Gives Smaller Doses of Monkeypox Vaccine to Expand Limited Supply – National


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