WASHINGTON (AP) — U.S. health officials Tuesday allowed up to five health care workers to vaccinate a limited number of people. approved a new monkeypox vaccination strategy aimed at increasing the supply of Not one, but one him per vial.
The so-called dose-sparing approach uses a fraction of the usual dose of the Jynneos vaccine and administers it 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 is that the United States currently lacks the supplies needed to vaccinate everyone seeking protection from the rapidly spreading virus. It is a clear acknowledgment that This includes the 1.6 to 1.7 million Americans who federal officials consider to be at the highest risk of the disease, mostly men who have or are at high risk of contracting HIV. To vaccinate that group would require about three times the amount made available to about 1.1 million officials.
Declaring it a public health emergency, it seeks 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 Gineos dose-saving technology.
The announcement was made last month. , FDA and others have repeatedly stressed that two full doses of the vaccine are required for adequate protection.
But regulators are now finding, in a 2015 study, that one-fifth of his conventional dose of vaccine produced a strong immune system response comparable to that of the full dose. pointing out that A study funded by the National Institutes of Health found that about 94% of people who received a small dose developed robust levels of virus-fighting antibodies compared to 98% of those who received a full dose.
The NIH plans additional trials of the technology in the coming months, according to the agency.
Because vaccine manufacturers often prescribe shots to provide adequate protection, it is not uncommon for lower doses to prove effective.
However, 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.
"I am deeply concerned by the limited amount of research that has been done on this dosage and method of administration, giving people a false sense of confidence that they are protected." "I'm afraid that we're going to be out of business," said David Harvey of the National Coalition of STD Directors.
Lower doses also require another type of injection that penetrates only the top layer of the skin rather than the lower layer between the skin and muscle. Requires training of department health care workers. The Centers for Disease Control and Prevention said it is providing educational materials about the technology as well as conducting a broader awareness campaign to the U.S. health sector.
Because the skin contains numerous immune cells that target foreign invaders, shallow injections are thought to help activate the immune system.
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 UK and Canada have adopted single-dose vaccine strategies that prioritize those at highest risk of monkeypox. Health departments in several large US cities have adopted a similar strategy amidst limited supplies. , and plans to distribute another 380,000 doses in the coming weeks. So far, it is recommended for people who have already had monkeypox or who may develop it from recent sexual contact in areas where the virus is endemic.
The Biden administration has been accused of 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 a 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 are lost when they are 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. According to the FDA label, animals that received two doses of the vaccine were more than twice as likely to survive after being infected with monkeypox than animals that did not.77} In an additional human study, people given Jynneos had immune responses similar to those given previous smallpox vaccines. It has not been tested in humans for smallpox or its relatives.
This is typical of many 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 on developing and stockpiling freeze-dried vaccines, replacing earlier liquid versions with shorter shelf lives. Bavarian Nordic has a 10-year contract with the US to supply the new vaccine.
AP's Health Sciences Division is supported by the Howard Hughes Medical Institute's Science Education Division. AP is solely responsible for all content.