Smallpox/monkeypox vaccine is approved by the FDA as a primary (2-dose) series to prevent infection caused by smallpox or monkeypox vaccine in people 18 years of age and older. The FDA has also approved an Emergency Use Authorization (EUA) for the Smallpox/Monkeypox vaccine (Jynneos) to allow:
- 2 doses of smallpox/monkeypox vaccine given 4 weeks apart in children and adolescents younger than 18 years of age.
Why get vaccinated?
Smallpox/Monkeypox vaccine can prevent infection with some types of orthopoxviruses including Smallpox, Monkeypox, and Vaccinia viruses.
Smallpox infection can cause a serious illness characterized by rash and fever that may result in death, for some.
Monkeypox infection can cause an illness similar to Smallpox. Although generally milder, it can still cause death.
Vaccinia virus infection can occur after someone is exposed to a person or an animal who has been exposed to the virus. It generally causes a self-limiting illness.
What is Smallpox/Monkeypox vaccine?Smallpox/Monkeypox vaccine is approved to prevent Smallpox or Moneypox disease in adults at high risk for Smallpox or Monkeypox infection. The Center for Diseases Control and Prevention recommend:
giving the vaccine to certain laboratory workers and emergency response team members who may be exposed to any of the covered orthopox viruses
consider giving the vaccine to people who administer ACAM2000 (Smallpox vaccine) or who care for people that are infected with an orthopox virus
Smallpox/Monkeypox vaccine is given as 2 doses 4 weeks apart. If you have already received another Smallpox vaccine, you may only need 1 dose.
Booster doses are recommended every 2 to 10 years to people who remain at high risk of exposure to orthopox viruses.
Smallpox/Monkeypox vaccine can be administered at the same time as other vaccines.
Talk with your healthcare providerTell your vaccination provider if the person getting the vaccine:
Has had an allergic reaction after a previous dose of Smallpox vaccine, or has any severe life-threatening allergies.
Is pregnant or thinks they might be pregnant or is breastfeeding.
Has a weakened immune system.
In some cases, your healthcare provider may decide to postpone pre-exposure Smallpox/Monkeypox vaccination until a future visit.
People with minor illnesses, such as a cold, may be vaccinated. People who are moderately or severely ill should usually wait until they recover before getting pre-exposure Smallpox/Monkeypox vaccine.
If you have been recommended to receive Smallpox/Monkeypox vaccine due to an exposure to Monkeypox vaccine, you should receive it regardless of concurrent illness, pregnancy, breastfeeding or weakened immune system.
Your healthcare provider can give you more information.
What are the risks of a vaccine reaction?
Soreness, redness, itching or swelling where the shot is given can happen after Smallpox/Monkeypox vaccination.
Fatigue, headache and muscle pain can also happen after Smallpox/Monkeypox vaccination.
People sometimes faint after medical procedures, including vaccination. Tell your doctor if you feel dizzy, or have vision changes or ringing in the ears.
As with any medication, there is a very remote chance of a vaccine causing a severe allergic reaction, other serious injury, or death.
What if there is a serious problem?
An allergic reaction could occur after the vaccinated person leaves the clinic. If you see signs of a severe allergic reaction (hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, or weakness), call 9-1-1 and get the person to the nearest hospital.
For other signs that concern you, call your health care provider.
Adverse reactions should be reported to the Vaccine Adverse Event Reporting System (VAERS). Your health care provider will usually file this report, or you can do it yourself. Visit the VAERS website at http://www.vaers.hhs.gov or call 1-800-822-7967. VAERS is only for reporting reactions, and VAERS staff members do not give medical advice.
The National Vaccine Injury Compensation Program
The National Vaccine Injury Compensation Program (VICP) is a federal program that was created to compensate people who may have been injured by certain vaccines. Claims regarding alleged injury or death due to vaccination have a time limit for filing, which may be as short as two years. Visit the VICP website at http://www.hrsa.gov/vaccinecompensation or call 1-800-338-2382 to learn about the program and about filing a claim.
How can I learn more?
Ask your healthcare provider.
Call your local or state health department.
Visit the website of the Food and Drug Administration (FDA) for vaccine package inserts and additional information at http://www.fda.gov/vaccines-blood-biologics/vaccines .
Contact the Centers for Disease Control and Prevention (CDC): call
1-800-232-4636 (1-800-CDC-INFO)or visit CDC's website at http://www.cdc.gov/vaccines .
Visit CDC's website at www.cdc.gov/poxvirus/monkeypox
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
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Selected Revisions: November 15, 2022.