Jynneos FDA Approval History
Last updated by Judith Stewart, BPharm on April 1, 2025.
FDA Approved: Yes (First approved September 24, 2019)
Brand name: Jynneos
Generic name: smallpox and mpox vaccine
Dosage form: Injection
Company: Bavarian Nordic A/S
Treatment for: Mpox, Smallpox Prophylaxis
Jynneos (smallpox and mpox vaccine, live, non-replicating) is a vaccine for the prevention of smallpox and mpox disease.
- Jynneos is indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or mpox infection.
- Jynneos is made from a modified form of the vaccinia virus called Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), which is non-replicating and incapable of reproducing in human cells. Jynneos is therefore suitable for use in people with weakened immune systems or who are at high risk of adverse reactions to traditional smallpox vaccines, which are based on replicating vaccinia virus strains.
- Jynneos is administered via subcutaneous injection as two doses, given four weeks apart.
- Common adverse reactions:
- in people who have not previously been vaccinated with a smallpox vaccine include pain, redness, swelling, induration (hardening of soft tissue), itching, muscle pain, headache, fatigue, nausea, and chills.
- in people who have previously been vaccinated with a smallpox vaccine include redness, pain, induration, swelling, itching, fatigue, headache, and muscle pain.
Development timeline for Jynneos
Further information
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