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Jynneos FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 16, 2022.

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: Monkeypox, Smallpox Prophylaxis

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.
  • 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.
    In August 2022, the U.S. FDA issued an emergency use authorization (EUA) for the Jynneos vaccine to allow healthcare providers to administer the vaccine by intradermal injection in high risk individuals 18 years of age and older, thereby increasing the total number of doses available for use by up to five-fold to meet demand. The EUA also allows for the use of the vaccine in individuals younger than 18 years of age determined to be at high risk of monkeypox infection; in these individuals Jynneos is administered by subcutaneous injection.
  • Common adverse reactions in people who have previously been vaccinated with a smallpox vaccine include redness, pain, induration (hardening of soft tissue), swelling, itching, fatigue, headache, and muscle pain.
    Common adverse reactions in people who have not previously been vaccinated with a smallpox vaccine include pain, redness, swelling, induration, itching, muscle pain, headache, fatigue, nausea, and chills.

Development timeline for Jynneos

Aug  9, 2022Monkeypox Update: FDA Authorizes Emergency Use of Jynneos Vaccine to Increase Vaccine Supply
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.