Smallpox and monkeypox vaccine

This vaccine helps prevent smallpox and monkeypox diseases.

Like any vaccine, the smallpox and monkeypox vaccine may not protect every person from disease.

Your doctor or pharmacist can give you more information about this vaccine. You can also find extra information from your local health department or the Centers for Disease Control and Prevention.

Smallpox and monkeypox vaccine is injected under the skin, ideally into the upper arm, or between the layers of the skin. You will receive this vaccine at a doctor's office, clinic, or pharmacy.

Smallpox and monkeypox vaccine is given in two doses 4 weeks apart. Speak with your doctor if you had a severe reaction after the first dose.

Use only as directed. Inform your doctor if you are taking other medicines or if you have other medical conditions or allergies.

You should not receive this vaccine if you have ever had a life-threatening allergic reaction to a smallpox and monkeypox vaccine.

Tell your doctor if you have a weak immune system due to certain medicines like steroids, chemotherapy, or radiation.

Tell your doctor if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Common side effects of smallpox and monkeypox vaccine may include:

• pain, redness, swelling, or itching where the vaccine was injected;
• muscle pain;
• headache;
• tiredness;
• nausea; or
• chills.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1 800 822 7967.

Usual Adult Dose for Smallpox Prophylaxis:

SMALLPOX AND MONKEYPOX PROPHYLAXIS (FDA Authorized Use):Two subcutaneous doses of 0.5 mL each, 4 weeks apartComment:-For subcutaneous injection onlyUse: Prevention of smallpox and monkeypox disease in adults 18 years or older at high risk of infection.EMERGENCY USE AUTHORIZATION (EUA) TO MEET NEEDS DURING MONKEYPOX OUTBREAK:Two intradermal doses of 0.1 mL each, 4 weeks apartComments: -For intradermal injection only-This drug has not been approved for this use.Use: Issued as EUA for prevention of monkeypox disease in adults 18 years or older at high risk of infection.

Usual Adult Dose for Monkeypox:

SMALLPOX AND MONKEYPOX PROPHYLAXIS (FDA Authorized Use):Two subcutaneous doses of 0.5 mL each, 4 weeks apartComment:-For subcutaneous injection onlyUse: Prevention of smallpox and monkeypox disease in adults 18 years or older at high risk of infection.EMERGENCY USE AUTHORIZATION (EUA) TO MEET NEEDS DURING MONKEYPOX OUTBREAK:Two intradermal doses of 0.1 mL each, 4 weeks apartComments: -For intradermal injection only-This drug has not been approved for this use.Use: Issued as EUA for prevention of monkeypox disease in adults 18 years or older at high risk of infection.

Usual Pediatric Dose for Monkeypox:

EMERGENCY USE AUTHORIZATION (EUA) TO MEET NEEDS DURING MONKEYPOX OUTBREAK:Two subcutaneous doses of 0.5 mL each, 4 weeks apartComments:-For subcutaneous injection only-This drug has not been approved for this useUse: Issued as EUA for prevention of monkeypox disease in individuals younger than 18 years of age.

Be sure to get all the recommended doses of this vaccine. You may not be fully protected against the disease if you do not complete the full series.

Since this vaccine is given by a healthcare professional, an overdose of smallpox and monkeypox vaccine is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Before getting this vaccine, let your doctor know about all the other vaccines you have had recently.

Also inform your doctor if you have recently taken any drugs or treatments that can weaken your immune system, such as:

• an oral, nasal, inhaled, or injectable steroid medicine;
• medications for psoriasis, rheumatoid arthritis, or other autoimmune disorders; or
• medicines to treat or prevent organ transplant rejection.

This list is not complete. Other medications may interact with smallpox and monkeypox vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are included in this medication guide.