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August 10, 2022 |
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FDA Authorizes Emergency Use of Monkeypox JYNNEOS Vaccine CDC Udpates Interim Clinicial Consideration for Monkeypox Vaccination |
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On August 9, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization. The EUA for the JYNNEOS vaccine allows healthcare providers to administer the vaccine by intradermal injection for individuals ages 18 years and older who are at high risk for monkeypox infection, which will results in an up to five-fold increase in the total number of doses available for use. The EUA also allows for use of the vaccine in individuals younger than 18 years old who are at high risk of monkeypox infection. In these individuals JYNNEOS is administered by subcutaneous injection.
In addition, the Centers for Disease Control and Prevention (CDC) has released Interim Clinical Considerations for Use of JYNNEOS and ACAM2000 Vaccines during the 2022 U.S. Monkeypox Outbreak that provides interim guidance for healthcare professionals and public health officials regarding use of JYNNEOS and ACAM2000 vaccines during the monkeypox outbreak that began in the United States on May 17, 2022. Considerations apply only to the use of vaccine products in the United States. JYNNEOS vaccine is licensed as a series of two doses administered 28 days (4 weeks) apart. In the context of the current national Public Health Emergency (PHE), two dosing regimens may be used.
The standard regimen involves a subcutaneous (Subcut) route of administration with an injection volume of 0.5mL. The standard regimen is the FDA-approved dosing regimen. Since August 9, 2022, the standard regimen has been authorized for people 18 years old under an Emergency Use Authorization.
An alternative regimen may be used for people ages ≥18 years or older under an EUA beginning August 9, 2022. The authorized alternative regimen involves an intradermal (ID) route of administration with an injection volume of 0.1mL. This approach could increase the number of available JYNNEOS vaccine doses by up to five-fold. Results from a clinical study showed that the lower intradermal dose was similar to the standard subcutaneous dose (Frey SE et al, Vaccine, 2015; 33(39):5225-5234).
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