One of the priorities of the Biden-Harris administration is the fight against the monkeypox outbreak, which was announced a few days ago. national emergency as part of a strategy to contain the pathogen and thus allows more federal funds to be allocated to healthcare facilities and could accelerate the development of treatments, as well as diagnostics and drugs to prevent spread.
The White House announced this in an official statement, which measures to increase the number of vaccine doses available up to five times through an alternative dosing regimen as part of the U.S. announcement of an emergency use authorization for the JYNNEOS vaccine, which will be given intradermally, requiring a lower dose, allowing up to five times the number of available doses, while continuing to ensure that the vaccine meets high safety and quality standards.
Plan of the White House
The Department of Health and Human Services (HHS) has announced a Section 564 declaration that allows the FDA to use its authority to allow health care providers to inject up to five times the number of vaccine doses per vial of JYNNEOS vaccine.
HHS Secretary Xavier Becerra issued the determination under Section 564 of the Food, Drug, and Cosmetic Act, stating that authorizes emergency authorization for the use of vaccines to prevent monkeypox and prevent serious illness from the virus.
HHS Assistant Secretary for Preparedness and Response Dawn O’Connell asked the Minister to issue a Section 564 decision and declaration of a public health emergency last week. This statement allows HHS is taking emergency action based on currently available information about the monkeypox virus.
FDA granted emergency use authorization for that the JYNNEOS vaccine be administered intradermallyallowing for a five-fold increase in the current vaccine supply without compromising safety and quality.
Administration demands a different type of needle to administer the current vaccine, similar to tuberculin skin test (or PPD) or intradermal allergy testing.
Administration, Centers for Disease Control (CDC) will conduct trainings and educational events for physicians, public health officials, health care providers and patients to ensure that jurisdictions can effectively administer the vaccine using this alternative dosing regimen.
Team 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 authorities.
The administration will actively involve providers and doctors to make sure they are ready to use this approach for the majority of adults who need the JYNNEOS vaccine.
Following the White House announcement, the 400,000 vials of vaccine in the SNS stockpile that have been isolated but not yet distributed could provide up to 2 million doses by intradermal injection. Also, vaccines that have been received by jurisdictions but not yet introduced are suitable for intradermal administration.
Source: La Opinion
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