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The Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) for the Gynneos monkeypox vaccine on Tuesday.
The move will allow health care providers to use the vaccine in a shallower intradermal injection for individuals over the age of 18 who are determined to be at high risk of contracting the virus.
The agency said the update would increase the total number of available doses by up to five times, as fewer doses are required for intradermal administration.
In addition, the FDA’s EUA also permits the use of the vaccine by subcutaneous injection or subcutaneous injection for individuals under the age of 18 who are determined to be at high risk of infection.
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“In recent weeks, the monkeypox virus has continued to spread rapidly, making it clear that the current vaccine supply is not meeting current demand,” FDA Commissioner Dr. Robert M. Calif said in a release. Stated. “The FDA has quickly considered other scientifically sound options to make vaccines available to all affected individuals. more people who want the vaccine will have the opportunity.”
So far, vaccination is recommended for people who have had monkeypox or who are likely to contract monkeypox due to recent sexual contact in areas where the virus is endemic.
The virus can be spread to anyone through close, personal, often skin-to-skin contact, including direct contact with objects and surfaces used by monkeypox patients.
A pregnant person can spread the virus to the fetus through the placenta.
Two doses of the vaccine are given 4 weeks apart. Those who received the first dose subcutaneously may receive the second dose intradermally or subcutaneously. There are no data to show that her single dose of the vaccine provides long-term protection.
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Agency officials also stressed the importance of getting two doses of the vaccine.
FDA Vaccine Commissioner Dr. Peter Marks said in a statement.
The FDA’s action follows a 564 decision issued by Secretary of Health and Human Services (HHS) Xavier Becerra.
HHS said it had made more than 1.1 million doses of monkeypox vaccine available for order as of Tuesday. The Biden administration said it has distributed more than 670,000 vaccines to states and jurisdictions from the Strategic National Stockpile (SNS).
SNS is preparing to distribute approximately 400,000 additional vials to states and jurisdictions as part of the next phase of the National Vaccine Strategy.
The White House said, “To implement this approach quickly and effectively, increasing the supply of Jynneos vaccine doses five-fold, the Biden-Harris administration will work with healthcare professionals on how to administer the Jynneos vaccine intradermally. We are launching a strong effort to train providers.” OK.
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The administration noted that the policy would increase the current 440,000 vials available as full doses to more than 2 million small doses.
The White House last week declared monkeypox a public health emergency. In the United States, he has nearly 9,500 confirmed cases of monkeypox and orthopoxvirus.
The Associated Press contributed to this report.