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Jynneos FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 23, 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 disease in adults 18 years of age and older.

  • 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

Sep 24, 2019Approval  FDA Approves Jynneos (Smallpox and Monkeypox Vaccine, Live, Non-replicating) for Prevention of Smallpox and Monkeypox Disease in Adults
Jun 19, 2019Bavarian Nordic Initiates Phase 3 Trial of Freeze-dried MVA-BN® Smallpox Vaccine
Mar 11, 2019Bavarian Nordic Announces FDA Delay in the Review of the Biologics License Application for MVA-BN Smallpox Vaccine
Dec 21, 2018Bavarian Nordic Announces FDA Acceptance and Priority Review of Biologics License Application for MVA-BN Smallpox Vaccine
Feb  6, 2018Bavarian Nordic Announces Positive Results of Pivotal Phase 3 Study of Imvamune Smallpox Vaccine

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.