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ACAM2000: Uses, Side Effects and Dosage

Status:
Current status: Restricted Access Facts
Strength:
1250000 PFU
Active ingredient:
ATC code:
Similar drugs:

Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - ACAM2000

Serious Warnings and Precautions

  • Serious heart problems called myocarditis and/or pericarditis (swelling of the heart tissues), or heart attack or other diseases of the heart
  • Swelling of the brain or spinal cord
  • Problems with the vaccination site blister (such as it becoming infected)
  • Spreading of the vaccine virus to other parts of your body or to another person
  • Severe allergic reaction after vaccination
  • Accidental infection of the eye (which may cause swelling of the cornea and blindness)
  • Vaccinia virus can cross the placenta and cause infection in the fetus/baby

  • These risks, including risks of severe disability and/or death, are increased in individuals who already have/are:

    • Heart disease
    • Eye disease treated with topical steroids
    • Immune system problems
    • History or presence of eczema or atopic dermatitis, and other active skin conditions
    • Infants (less than 12 months old)
    • Pregnant or breastfeeding
  • ACAM2000 vaccine contains a live vaccinia virus that can be spread to persons who have close contact with the person who receives the vaccine (vaccinee). The risks for the contacts are the same as they are for the vaccinees.

What is ACAM2000 vaccine used for?

ACAM2000 vaccine is used for vaccination (active immunization) against smallpox (to protect people against smallpox disease). It is used in people who have a high chance of getting the disease.

How does ACAM2000 vaccine work?

ACAM2000 vaccine contains a live vaccinia virus (a “pox”-type virus) that activates your immune system to protect you against smallpox disease.

What are the ingredients in ACAM2000 vaccine?

Medicinal ingredients: Smallpox Vaccine

Non-medicinal ingredients: 5% mannitol, USP; 2% human serum albumin, USP (HSA); 0.5 – 0.7% sodium chloride, USP; 6 – 8 mM HEPES (pH 6.5 – 7.5); trace amounts of antibiotics (neomycin and polymyxin B), 50% (v/v) glycerin, USP and 0.25% (v/v) phenol, USP in Water for Injection (WFI) USP.

ACAM2000 vaccine comes in the following dosage forms:

You will be given 15 jabs into your arm with a special needle containing 2.5-12.5x105 plaque forming units (PFU) per dose (2.5 µL).

Do not use ACAM2000 vaccine if:

Your healthcare professional may not give you ACAM2000 vaccine if you have problems with your immune system such as:

  • have leukemia
  • have lymphoma
  • have had a bone marrow or organ transplant
  • have cancer that has spread
  • have HIV, AIDS
  • have cellular or humoral immune deficiency
  • are being treated with radiation
  • are being treated with steroids, prednisone, or cancer drugs

To help avoid side effects and ensure proper use, talk to your healthcare professional before you are given ACAM2000 vaccine. Talk about any health conditions or problems you may have, including if you have/are:

  • Heart disease
  • Eye disease treated with topical steroids
  • Allergies
  • Problems with your immune system
  • A history or presence of eczema or atopic dermatitis, and other active skin conditions

  • Infants < 12 months of age

  • Pregnant or breastfeeding

Other warnings you should know about:

Care of the Vaccination site:

  • The vaccination site must be completely covered with a bandage. Keep the site covered until the scab falls off on its own.
  • The vaccination site must be kept dry. Cover the vaccination site with waterproof bandage when bathing. Do not scrub the site. Cover the vaccination site with loose gauze bandage after bathing.
  • Don’t scratch the vaccination site.
  • Don’t scratch or pick at the scab.
  • Do not touch the lesion or soiled bandage and then touch other parts of the body like the eyes, anal and genital areas where the virus can spread.

  • After changing the bandage or touching the site, wash your hands thoroughly with soap and water or >60% alcohol-based hand-rub solutions.

  • Avoid touching objects that have come into contact with the lesion (e.g., soiled bandages, clothing, bedding, fingers) to keep the virus from spreading.
  • Wash separately clothing, towels, bedding or other items that may have come in direct contact with the vaccination site or drainage from the site, with hot water with detergent and/or bleach. Wash hands afterwards.
  • Soiled bandages must be placed in sealed plastic bags for disposal.
  • Wear a shirt with sleeves that covers the vaccination site to prevent spread of the vaccinia virus. This is important in case of close physical contact.
  • Change the bandage every 1 to 3 days. This will keep skin at the vaccination site intact and minimize softening.
  • Do not put salves or ointments on the vaccination site.
  • When the scab falls off, throw it away in a sealed plastic bag and wash hands afterwards.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ACAM2000 vaccine:

There are no known drugs that interact with ACAM2000 vaccine. Avoid getting vaccinated with other vaccines at the same time as ACAM2000. If you must get more than one vaccination at the same time, inform your healthcare professional you would like another limb as the vaccination site.

How to take ACAM2000 vaccine:

  • Your healthcare professional will vaccinate you with ACAM2000 vaccine in a healthcare setting.
  • DO NOT INJECT INTRAVENOUSLY.

Usual dose:

Your healthcare professional will administer the dose of ACAM2000 vaccine. A special needle will be used to puncture your skin 15 times.

What are possible side effects from using ACAM2000 vaccine?

These are not all the possible side effects you may have when taking ACAM2000 vaccine. If you experience any side effects not listed here, tell your healthcare professional.

  • Swollen lymph nodes
  • Sore arm
  • Fever
  • Headache
  • Body ache
  • Mild rash
  • Lymph node pain
  • Nausea
  • Diarrhea
  • Constipation
  • Vomiting
  • Itchiness, redness, swelling or pain at the vaccination site
  • Feel tired or unwell
  • Feeling hot
  • Chills
  • Exercise tolerance decreased
  • Muscle pain
  • Short of breath
  • Rash
  • Allergy

Serious side effects and what to do about them

Symptom / effectTalk to your healthcare professionalStop taking drug and get immediate medical help
Only if severeIn all cases
RARE:
Myocarditis: chest pain, tightening of chest (chest rub), shortness of breath, increase heart rate and tirednessXN/A
VERY RARE:
Cardiomyopathy: chest pain, tightening of chest (chest rub), shortness of breath, increase heart rate and tirednessXN/A

Serious side effects and what to do about them

Symptom / effectTalk to your healthcare professionalStop taking drug and get immediate medical help
Only if severeIn all cases
Encephalopathy: fatigue, mental confusion, problems with coordination, seizure, headache, personality changeXN/A
Skin diseases: ulcer, skin discharge, pain, skin lesion, bleeding, discolorationXN/A
Eye infection: blurry vision caused by the infection, eye pain, light sensitivity, white/yellow discharge, blurred visionXN/A
Infection by touch: rash, ulcer, skin discharge, pain, skin lesion, bleeding, discolorationXN/A

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

  • Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
  • Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Reporting Suspected Side Effects for Vaccines

For the general public: Should you experience a side effect following immunization, please report it to your healthcare professional.

Should you require information related to the management of the side effect, please contact your healthcare professional. The Public Health Agency of Canada, Health Canada and Emergent BioSolutions cannot provide medical advice.

For healthcare professionals: If a patient experiences a side effect following immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory (http://www.phac-aspc.gc.ca/im/aefi-essi-form-eng.php) and send it to your local Health Unit.

Storage:

Your healthcare professional is responsible for storing this vaccine and disposing of any unused product correctly. Do not use after the expiry date stated on the label. Keep out of reach and sight of children.

If you want more information about ACAM2000 vaccine:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.ACAM2000CanadaPM.com, by calling 1-800-768-2304, or by sending an email to medicalinformation@ebsi.com.

Last Revised: TBD

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02543699

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for ACAM2000

DIN 02543699
Schedule(s) SCHEDULE D
Active ingredient(s) Vaccinia virus, live 1250000 PFU
Dosage form(s) Powder For Solution
Route(s) of administration Percutaneous
Drug class (WHO ATC)
  1. J Antiinfectives for systemic use
    1. J07 Vaccines
      1. J07B Viral vaccines
        1. J07BX Other viral vaccines
          1. J07BX01 Smallpox and mpox vaccines
Company EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.
Current status Restricted Access
Current status date June 20, 2024

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.