Criteria & Principles
JYNNEOS is a FDA approved (2019) vaccine indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. It is a replication-deficient live Vaccinia virus vaccine.
Vaccination can occur at Health Departments across the state and in the Duke 1J and 1K clinics. Vaccination is restricted to the outpatient setting at this time.
Treatment
Severity
All Severity
Administer two doses (0.5 mL) subcutaneously 28 days apart.
CDC recommends that the vaccine be given within 4 days from the date of exposure for the best chance to prevent onset of the disease. If given between 4 and 14 days after the date of exposure, vaccination may reduce the symptoms of disease, but may not prevent the disease.
Preparation and Administration
- Allow the vaccine to thaw and reach room temperature before use. Once thawed, the vaccine may be kept at +2°C to +8°C (+36°F to +46°F) for 12 hours. Do not refreeze.
- When thawed, JYNNEOS is a milky, light yellow to pale white colored suspension. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.
- Swirl the vial gently before use for at least 30 seconds.
- Withdraw a dose of 0.5 mL into a sterile syringe for injection.
- Administer JYNNEOS by subcutaneous injection, preferably into the upper arm (deltoid).
Adverse Effects
Most common (> 10%) solicited injection site reactions were pain (84.9%), redness (60.8%), swelling (51.6%), induration (45.4%), and itching (43.1%); the most common solicited systemic adverse reactions were muscle pain (42.8%), headache (34.8%), fatigue (30.4%), nausea (17.3%) and chills (10.4%)
References
Package Insert - JYNNEOS (fda.gov)
Vaccine Information Sheet (VIS)
Duke Infection Prevention Monkeypox ToolKit
**** Emergency Use Authorization: Issued 8/9/22***
EUA was provided to Jynneos to allow for subcutaneous administration in < 18 year olds and intradermal injection of 0.1 mL in those 18 years of age and older. When utilizing in this population the patient must be provided the Fact Sheet for Patients and Caregivers . More information can be found in the Fact Sheet for Providers.
Individuals less than 18 years of age:
- For subcutaneous injection only.
- Administer two doses (0.5 mL each) 4 weeks apart.
Individuals 18 years of age and older:
- For intradermal injection only.
- Administer two doses (0.1 mL each) 4 weeks apart. (2.1, 2.2)
Once thawed, the vaccine may be kept at +2°C to +8°C (+36°F to +46°F) for 8 weeks. After first puncture vial can be stored at +2°C to +8°C (+36°F to +46°F) for up to 8 hours.