US expands supply of monkeypox vaccine with smaller doses

On Tuesday, US health officials announced that the country's who have approved plans to expand the limited supply could reduce the effectiveness of the monkeypox vaccine by administering only one-fifth of the normal dose.

The so-called dose-sparing approach also calls for administering the ginneos vaccine by injection just under the skin rather than in deeper tissues. The recipient will get his two shots at four week intervals.

The highly unusual measure underlines that the United States currently lacks the supplies needed to vaccinate everyone seeking protection from the rapidly spreading virus. I acknowledged it.

This includes the 1.6 million to 1.7 million Americans who federal officials consider to be at the highest risk of the disease, primarily because of his HIV infection or infection. men at high risk. To vaccinate that group would require about three times the full dose of about 1.1 million people the authorities have made available.

The White House monkeypox response coordinator, Robert Fenton, said the plan would help the US "get ahead of the virus."

"It will significantly expand the dose of a vaccine that is safe, effective, and available to communities across the country," Fenton told reporters.

The Biden administration declared monkeypox a public health emergency last week, seeking to slow the spread of an epidemic that has infected more than 8,900 Americans. Officials announced another decision on Tuesday. This will allow the Food and Drug Administration to expedite the review of medical products or their new uses, such as the dose-saving technology of Gineos.

Approved a new approach for adults 18 years and older who are at high risk of infection. Young people can be vaccinated if they are judged to be at high risk, but they must have a conventional injection.

The announcement represents a shift from last month, when the FDA and others repeatedly stressed that two full doses of his vaccine were required for adequate protection. ing.

However, regulators now believe that a 2015 study found that one-fifth the conventional dose of the vaccine produced a strong immune system response comparable to that of the full dose. pointing out. A study funded by the National Institutes of Health found that about 94% of people given low doses had sufficient levels of antibodies to fight the virus, whereas those given full doses

According to the agency, the NIH plans additional trials of this technique in the coming months.

Since vaccine manufacturers often prescribe shots to provide adequate protection, it is not uncommon for lower doses to prove effective.

But some experts and advocates warn that there is little data to support the policy, and fear it could backfire if the vaccine becomes less effective. .

``We are gravely concerned about the limited amount of research that has been done on this dose and method of administration, giving people false confidence that they are protected. "I am concerned that the National Coalition of STD Directors will continue to do so," David Harvey said in a statement.

For lower doses, another type of injection is also required that penetrates only the top layer of skin rather than the lower layer between skin and muscle. This is a less common technique and may require training of some healthcare workers. It also has side effects such as redness, itching, and swelling.

Shallow injections are thought to help stimulate the immune system because the skin contains numerous immune cells that target foreign invaders.

The Centers for Disease Control and Prevention said it would provide educational materials on the technology and conduct a broader awareness campaign for the US health sector.

Vaccine dose distribution is common in Africa and other parts of the world where medical resources are limited. In recent years, the World Health Organization has endorsed approaches to combat yellow fever, polio, and other disease outbreaks.

"This is not an uncommon situation," said Dr. William Moss of the Vaccine Access Center at Johns Hopkins. “It comes down to public health decision-making. Do we make this trade-off during an outbreak of inadequate supply?”

First COVID-19 vaccine available in late 2020 When it became possible, the UK government made it a priority to give as many people as possible the first dose before giving the second dose.

Both the United Kingdom and Canada have adopted single-dose vaccine strategies that prioritize those at highest risk of monkeypox. And the health departments of several large US cities, including New York, San Francisco and Washington, have adopted similar strategies amidst limited supplies. of vaccines have been shipped to state and local health departments, and an additional 380,000 doses will be distributed in the coming weeks. So far, it has been recommended for people who are likely to contract monkeypox due to previous exposure to monkeypox or recent sexual contact in areas where the virus is endemic.

The Biden administration has been criticized for not promptly clearing millions more doses from the country's strategic national stockpile. Most are not expected to be delivered until 2023.

The US government has a large quantity of vaccine components, equivalent to 16.1 million doses, under contract with Danish manufacturer Bavarian Nordic. However, the material must be sealed in vials, and the process is expected to take several months as the small company handles orders from other countries.

HHS announced last week that the government critics about the pace and timing of vaccine decisions.

"We carefully considered when and how we would use bulk vaccines because years of shelf life would be lost when they were taken out of bulk," said a spokesperson. The official said in an emailed statement.

The FDA approved his Jynneos vaccine to prevent smallpox and monkeypox in 2019, based in part on studies in monkeys. Animals that received two doses of the vaccine were more than twice as likely to survive after being infected with monkeypox as animals that did not, according to FDA labeling.

Additional Human Studies In , people given Jynneos had immune responses similar to those given previous smallpox vaccines. not tested in humans.

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

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