JYNNEOS Smallpox and Monkeypox Vaccine
The vaccine uses a live attenuated, non-replicating vaccinia virus (Modified Vaccinia Ankara, MVA) that elicits humoral and cellular immune responses following the infection with the smallpox or monkeypox viruses.
The vaccine is manufactured by Bavarian Nordic A/S.
Indication For Use and Limitations
The vaccine’s indication for use is for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.
Vaccination with JYNNEOS may not protect all recipients. In particular, Immunocompromised persons may have a reduced immune response to JYNNEOS.
Safety and effectiveness of JYNNEOS have not been established in individuals less than 18 years of age.
The vaccine consists of ready-to-use single-dose vials of 0.5 mL. The vaccine is shipped at -20°C and stored frozen at -25°C to -15°C. Just before use, the vaccine is allowed to thaw and reach room temperature.
The vaccine is administered by subcutaneous (SQ) injections. The vaccine consists of two doses of 0.5 mL each, administered 28 days apart.
The JYNNEOS Smallpox and Monkeypox Vaccine is a milky, light yellow to pale white colored suspension.
The non-replicating vaccinia virus MVA is cultured in Chicken Embryo Fibroblast cells and a serum-free medium. It is purified and filtered from the Fibroblast cells using various methods.
The JYNNEOS vaccine is provided as a sterile suspension without preservatives.
Each 0.5 mL vaccine dose contains 0.5 x 10E8 to 3.95 x 10E8 infectious units of the MVA live virus in:
- 10 mM Tris (tromethamine, a buffer), pH 7.7
- 140 mM sodium chloride (a salt)
Each 0.5 mL vaccine dose may contain residual amounts of:
- Host-cell DNA (≤ 20 micrograms).
- Various Proteins (≤ 500 micrograms).
- Benzonase (≤ 0.0025 microgram). This an en enzyme that attacks and degrades all forms of DNA and RNA.
- Gentamicin (≤ 0.163 microgram). This an antibiotic used to treat several types of bacterial infections.
- Ciprofloxacin (≤ 0.005 microgram). This is another antibiotic used to treat a number of bacterial infections.
- JYNNEOS. Retrieved from https://www.fda.gov/vaccines-blood-biologics/jynneos
- JYNNEOS Package Insert. Retrieved from https://www.fda.gov/media/131078/download
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