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One of the priorities of the Biden-Harris Administration is to combat the outbreak of monkeypox, which days ago was declared a health emergency in the country as part of a strategy to contain the pathogen and thus allow the release of more federal funds for health agencies and can accelerate the development of therapies, as well as diagnostics and medicines that prevent the spread.
The White House has made known through an official statement that took measures to increase the number of vaccine doses available up to five times via an alternative dosing regimen, this as part of the US Emergency Use Authorization announcement for the JYNNEOS vaccine to be administered by the intradermal route which requires a smaller dose, allowing the amount of available doses increase up to five times while continuing to ensure that the vaccine meets high standards of safety and quality.
The White House Plan
The Department of Health and Human Services (HHS) announced a declaration of Section 564, which allows the FDA to use its authority to allow health care providers administer up to five times the number of vaccine doses per vial of JYNNEOS vaccine.
HHS Secretary Xavier Becerra issued a determination under the declaration of Section 564 of the Food, Drug, and Cosmetic Act that allows emergency use authorization of vaccines to prevent monkeypox and prevent serious illness from the virus.
HHS Assistant Secretary for Preparedness and Response Dawn O’Connell requested that the Secretary issue last week’s Section 564 determination and declaration of public health emergency. This statement allows HHS take emergency action based on currently available information on the monkeypox virus.
The FDA granted Emergency Use Authorization for that the JYNNEOS vaccine be administered intradermallyallowing the current vaccine supply to be increased fivefold without sacrificing safety and quality.
The administration requires a different type of needle to administer the current vaccine, similar to the administration of a tuberculin skin test (or PPD) or intradermal allergy tests.
The Administration, the Centers for Disease Control (CDC) will carry out trainings and outreach activities for physicians, public health officials, providers, and patients to ensure that jurisdictions can effectively administer the vaccine using this alternative dosing regimen.
The team of White House National Response to Monkeypox Outbreak to Oversee Rapid Implementation and coordination of this strategy by HHS, CDC, FDA, and state and local health officials.
The Administration will actively engage providers and physicians to ensure they are prepared to use this approach for most adults who need the JYNNEOS vaccine.
Following the White House announcement, the 400,000 vials of vaccine in the SNS inventory that have been allocated but not yet distributed have the potential to provide up to 2 million doses via intradermal administration. Also, vaccines that have been received by jurisdictions, but not yet administered, are eligible for intradermal administration.
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