Monkeypox vaccine authorization has been extended by the FDA to increase dose availability


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The Food and Drug Administration (FDA) on Tuesday extended the Emergency Use Authorization (EUA) of the Zinios monkeypox vaccine.

The measure allows health care providers to use the vaccine with a shallow intradermal injection for individuals 18 years of age and older, who are at high risk of infection from the virus.

The update will increase the total number of doses available for use by five times as intradermal administration requires a lower dose, the agency said.

Additionally, the FDA’s EUA allows the vaccine to be used — administered by subcutaneous injection or injection under the skin — in individuals younger than 18 years of age determined to be at high risk of infection.

Monkeypox in America: Who’s at Risk and Why?

“The monkeypox virus has continued to spread in recent weeks, making it clear that our current vaccine supply cannot meet current demand,” said FDA Commissioner Dr. Robert M. Calif said in a release. “The FDA quickly explored other scientifically sound options to facilitate access to the vaccine for all affected individuals. By increasing the number of doses available, more individuals who wish to receive the vaccine against monkeypox will now have the opportunity to do so.”

FILE – A registered nurse prepares a monkeypox vaccine at the Salt Lake County Health Department Thursday, July 28, 2022, in Salt Lake City. On Tuesday, August 9, 2022, US health officials authorized a new monkeypox vaccination strategy designed to stretch limited supplies by allowing health professionals to vaccinate five people — instead of one — with each vial.
(AP Photo/Rick Baumer, File)

So far, the shots have been recommended for people who have already been exposed to monkeypox or are likely to get it through recent sexual contact in areas where the virus is endemic.

The virus can spread to anyone through close, personal and frequent skin-to-skin contact, including direct contact with objects and surfaces used by someone with monkeypox.

A pregnant woman can transmit the virus to her fetus through the placenta.

The vaccine is given in two doses four weeks apart. Those who received their first dose subcutaneously may receive their second dose intradermally or subcutaneously. No data are available to suggest that a single dose of the vaccine provides long-term protection.

A Westchester Medical Center staff member applies the monkeypox vaccine to a person at a drive-thru monkeypox vaccination point at Westchester Medical Center in Valhalla, New York, US, on July 28, 2022.

A Westchester Medical Center staff member applies the monkeypox vaccine to a person at a drive-thru monkeypox vaccination point at Westchester Medical Center in Valhalla, New York, US, on July 28, 2022.
(REUTERS/Eduardo Munoz)

A monkeypox vaccination campaign has begun in Italy

Agency officials stressed the importance of getting two doses of the vaccine.

“We feel strongly that two doses are necessary because, in part, we have no evidence that people are adequately protected by a single dose after three, six, eight months,” said FDA vaccine Dr. Chief Peter Marks said in a release.

The FDA’s action follows a 564 resolution issued by Health and Human Services (HHS) Secretary Xavier Becerra.

Syringes used for a monkeypox vaccine are seen inside a bucket at a drive-thru monkeypox vaccination point at Westchester Medical Center in Valhalla, New York on July 28, 2022.

Syringes used for a monkeypox vaccine are seen inside a bucket at a drive-thru monkeypox vaccination point at Westchester Medical Center in Valhalla, New York on July 28, 2022.
(Reuters/Eduardo Munoz)

HHS said it had made 1.1 million monkeypox vaccine doses available to 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 Immunization Strategy.

“To quickly and effectively implement this method to increase ZINIOS vaccine dose supply fivefold, the Biden-Harris administration is launching a robust effort to train healthcare workers and providers on how to administer ZINIOS vaccine intradermally,” the White House said. observed.

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The administration noted that the policy would multiply the currently available 440,000 bottles in full to more than 2 million in smaller quantities.

The White House last week declared monkeypox a public health emergency. About 9,500 cases of monkeypox and orthopox virus have been confirmed in the US

The Associated Press contributed to this report.



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