Jynneos FDA Approval History
Reviewed by J.Stewart BPharm. Last updated on Sep 24, 2019.
FDA Approved: Yes (First approved September 24, 2019)
Brand name: Jynneos
Generic name: smallpox and monkeypox vaccine
Dosage form: Injection
Company: Bavarian Nordic
Treatment for: Prevention of Smallpox; Prevention of Monkeypox
Jynneos (smallpox and monkeypox vaccine, live, nonreplicating) is a vaccine indicated for the prevention of smallpox and monkeypox in adults.
- Jynneos is indicated in people who have been determined to be at high risk for infection from smallpox or monkeypox, which both belong to the Orthopoxvirus genus of viruses. Smallpox was declared eradicated worldwide in 1980 after a global vaccination campaign, and no longer occurs naturally, but could potentially re-emerge as result of deliberate or accidental release. Monkeypox has been reported more recently, with all cases having origins in Nigeria. With increased observations of human-to-human transmission, and a large foreign workforce based in central Africa, monkeypox vaccination may become an option for prospective travelers to affected areas.
- Jynneos is made from a modified form of the vaccinia virus called Modified Vaccinia Ankara, 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 side effects include injection site reactions, muscle pain, headache, fatigue, nausea, myalgia and chills.
Development Timeline for Jynneos
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