This vaccine is used to help prevent smallpox and monkeypox diseases.

Like any vaccine, the smallpox and monkeypox vaccine may not provide protection from disease in every person.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Your doctor or pharmacist can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.

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

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

Usual Adult Dose for Smallpox Prophylaxis:

SMALLPOX AND MONKEYPOX PROPHYLAXIS (FDA Authorized Use):
Two subcutaneous doses of 0.5 mL each, 4 weeks apart

Comment:
-For subcutaneous injection only

Use: 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 apart

Comments:
-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 apart

Comment:
-For subcutaneous injection only

Use: 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 apart

Comments:
-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 apart

Comments:
-For subcutaneous injection only
-This drug has not been approved for this use

Use: Issued as EUA for prevention of monkeypox disease in individuals younger than 18 years of age.

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 caused by receiving certain medicines such as steroids, chemotherapy or radiation.

Tell your doctor if you are pregnant or breastfeeding.

Be sure you receive all recommended doses of this vaccine. You may not be fully protected against disease if you do not receive 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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult 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.

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

• an oral, nasal, inhaled, or injectable steroid medicine;

• medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders; or

• medicines to treat or prevent organ transplant rejection.

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