The FDA has issued emergency authorization for a dosing technique that would allow for more shots per vial.
The United States Food and Drug Administration (FDA), a federal health agency, has announced an emergency use authorization (EUA) for a monkeypox vaccination method that could expand the availability of doses.
Under the order, health care providers can use a dosing technique that allows them to dispense more doses of JYNNEOS vaccine per vial. The FDA issued a statement Tuesday saying the change could increase the availability of the vaccine “up to five-fold.”
“In recent weeks, the monkeypox virus has been spreading at a rate that has made it clear that our current vaccine supply will not meet current demand,” FDA Commissioner Robert Calif said in a statement. Statement, “The FDA explores other scientifically appropriate options to facilitate access to the vaccine for all affected individuals.”
The authority was described as a “game changer” by Robert Fenton, who is overseeing the White House’s monkeypox response, at a press conference on Tuesday, and could mark a new phase in the government’s efforts against the disease. Huh. The EUA also allows high-risk individuals under the age of 18 to receive the vaccine.
The dosing method involves administering the vaccine “intravenously”, or between layers of the skin, “subcutaneously”, or subcutaneously. Administering the vaccine intrauterinely will allow medical workers to receive five doses per vial of JYNNEOS vaccine, which was approved in 2019 for the prevention of monkeypox. Calif called the practice “safe and effective.”
The FDA stated that a 2015 study showed that “intradermal administration produced a similar immune response to subcutaneous administration”. While the intradermal method produced few side effects such as “redness, firmness, itching and swelling,” the FDA described those effects as “manageable.”
There have been more than 9,400 cases of monkeypox in the US, more than any other country in the world, and in cities such as San Francisco and New York, the demand for vaccines has exceeded the supply.
Public health officials assured members of the press that the decision was the result of a sound and sound scientific process, not a political justification.
The spread of monkeypox was declared a public health emergency last week, freeing up additional government resources to help stop the spread of the virus, which the Biden administration has called a top priority.
According to the CDC, monkeypox is spread through “close, personal, often skin-to-skin contact.” Men who have sex with men have largely been affected by the virus, but health officials insist that anyone can be affected.
In late July, the World Health Organization (WHO) urged men who have sex with men to reduce their number of sexual partners, to reduce their risk of exposure. Rochelle Valensky, director of the Centers for Disease Control and Prevention (CDC), stressed that such protective measures are still an important aspect of reducing the risk of infection.
The United Nations has said journalists and public health officials should take care to ensure that communication about the disease “does not reinforce homosexual and racist stereotypes”.
Men who have sex with men have “demonstrated significant confidence in vaccines,” said Dr. Demetre Daskalakis, the White House’s National Monkeypox Response deputy coordinator, in response to questions about potential skepticism towards the newly-approved dosing method. . “I think we’re going to see that we still run out of vaccines before we run out of weapons.”
Credit: www.aljazeera.com /