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The two-dose monkeypox vaccine, JYNNEOS, licensed by FDA in 2019

Daniel R. Lucey, MD, MPH, FIDSA
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WHO, the U.S. CDC and additional sources in the U.K., Spain, Portugal, Sweden, Italy, Canada, and the USA have reported investigating confirmed and/or suspected cases of monkeypox in those countries this week. The epidemiology, clinical manifestations and sequencing of the viruses are being studied. WHO will convene a special meeting next week, coincidentally during the start of the annual World Health Assembly, May 22-28, to discuss monkeypox, an orthopoxvirus in the same family as smallpox. FDA in 2019 licensed one vaccine explicitly for monkeypox, as well as smallpox, using the vaccinia virus (a related but separate third orthopoxvirus).

Given some confusion in an early media report regarding the presence or absence of an FDA-licensed vaccine against monkeypox, FDA’s summary of the approval of this two-dose vaccine on Sept. 24, 2019, may be useful: The full statement provides information on the vaccine’s safety, immunogenicity and efficacy (not directly involving persons with monkeypox). In addition, the link to the 11-page package insert for this vaccine, named JYNNEOS and made by Bavarian Nordic in Denmark, can be found on FDA’s product information page for the vaccine.

Editor’s Note: Join experts for a webinar on May 24 at 6 a.m. ET on the recent outbreak of monkeypox cases across Europe and the U.S. Co-organized by IDSA and the European Society of Clinical Microbiology and Infectious Diseases, the joint web symposium will include panelists highlighting cases and a roundtable discussion. An on-demand version will be available for those unable to attend the live event. 

A CDC COCA Call on “What Clinicians Need to Know about Monkeypox in the United States and Multiple Countries” is also scheduled for May 24 at 2 p.m. ET.

Additional Monkeypox Resources:

  • CDC Health Advisory (May 20)
  • ESCMID update (May 20)
  • CDC’s vaccine guidance and related ACIP presentation
  • Free, self-paced WHO online course for public health officers and health care workers on monkeypox transmission, clinical presentation, diagnostics and treatment


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