| |
FDA Memo Monkeypox Dose Vaccine - JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Non- replicating)
|
| |
| |
Download the PDF here
Assessment of two doses (each 0.1 mL dose containing 2 x 107 TCID50 of MVA-BN) of JYNNEOS via the intradermal (ID) route of administration for prevention of monkeypox disease in individuals 18 years of age and older determined to be at high risk for monkeypox infection and the use of two-doses (each 0.5 mL dose containing 1 x 108 TCID50 of MVA-BN) of JYNNEOS via the subcutaneous (SC) route of administration for prevention of monkeypox disease in individuals under 18 years of age determined to be at high risk for monkeypox infection.
This memorandum provides a summary, review, and recommendation for the emergency use authorization (EUA) of JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Non-replicating) to authorize the administration of: (i) two doses (each 0.1 mL dose containing 2 x 107 TCID50 of MVA-BN, hereafter referred to as 0.1 mL) of JYNNEOS 4 weeks apart via the intradermal (ID) route of administration to individuals 18 years of age and older determined to be at high risk for monkeypox infection; and (ii) two doses (each 0.5 mL dose containing 1 x 108 TCID50 of MVA-BN, hereafter referred to as 0.5 mL) of JYNNEOS 4 weeks apart via the subcutaneous (SC) route of administration to individuals under 18 years of age determined to be at high risk for monkeypox infection.
|
|
| |
| |
|
|
|
