Mpox vaccination clinical resources: Sample information sheets, consent forms, after care sheets

Download in Word format the sample information sheet (107 KB)

Please read this information sheet carefully and ensure all your questions have been answered by a health care provider before receiving the vaccine.

What is mpox?

• Mpox is a viral disease that can be transmitted from animals to humans, from person-to person (including during sexual contact) or through direct contact with contaminated objects. Transmission can also occur from a pregnant person to their fetus. For more information on each mode of transmission, please consult this link: Mpox: How it spreads, prevention and risks.
• Symptoms of mpox can typically include: lesions or sores on your skin (including lesions in the genital or anal areas); lesions in your mouth; fever; and swollen lymph nodes. The number of lesions can vary from a few to more than a thousand.
• You can be contagious from onset of first symptoms until scabs have fallen off and the skin is healed. This can take a few weeks.
• Vaccines given before or soon after mpox exposure can help prevent infection.

How does the Imvamune vaccine protect against mpox?

• Imvamune is a Modified Vaccinia Ankara (MVA) vaccine manufactured by Bavarian Nordic. It was initially developed to be used for the prevention of smallpox, but its use has been expanded to help prevent mpox as well. When a person is given the vaccine, the immune system (the body's natural defense system) will produce its own protection in the form of antibodies against the smallpox and mpox viruses.
• Studies on Imvamune report varying levels of protection, with better protection after receiving 2 doses than just one. Studies of 2 doses have found that the vaccine is 65 to 85% effective at preventing mpox infection, while 1 dose protection ranged from 35 to 85%. If someone who has had 1 or 2 doses of Imvamune, their infection is generally milder than those who are not vaccinated.
• We don't yet know how long protection against mpox lasts.
• It takes about 2 weeks after vaccination for your immune system to build up protective responses against mpox.

Who can and cannot receive the smallpox/mpox vaccine at this time?

• The Imvamune vaccine is authorized for adults 18 years of age and older who do not have contraindications.
• Although Imvamune is not authorized for children and evidence regarding its use in children is limited, children may be at higher risk of severe outcomes from mpox infection and may benefit from vaccination.

Table 1 indicates who should and should not receive the Imvamune vaccine and provides some questions you may be asked before being vaccinated and possible recommendations based on your response. These recommendations are based on the advice of the National Advisory Committee on Immunization (NACI).

How is the vaccine administered?

The vaccine is usually administered into the fatty layer under the skin (subcutaneous tissue). This is usually in the back of the upper arm (triceps area) or in young children, in the outer part of the thigh (anterolateral thigh area). Two doses are recommended, given at least 28 days apart.

What are the risks of the vaccine?

• Imvamune vaccine has been authorized by Health Canada for active immunization against smallpox, mpox and related orthopoxvirus infection and disease under the provision of the Extraordinary Use New Drug (EUND) regulations in individuals 18 years of age and older determined to be at high risk for exposure. Once approved, vaccines continue to be monitored closely for safety and effectiveness by Health Canada in cooperation with provinces, territories, other countries and international agencies.
• Imvamune does not contain smallpox or mpox virus and cannot spread or cause smallpox or mpox.
• Side effects can develop within a few days after receiving the vaccine. Although most side effects are not serious to your health, they may make you feel unwell for a few days; they will go away on their own. Some common and expected side effects include one or more of the following:
  • reactions where the vaccine was given (for example, pain, redness, swelling and itching)
  • tiredness
  • headache
  • muscle aches or pain
  • chills
  • nausea
• Rarely allergic reactions can occur after receiving a vaccine. Symptoms of an allergic reaction include:
  • difficulty breathing
  • hives (bumps on the skin that are often very itchy)
  • swelling of your face, tongue or throat
• The clinic staff are prepared to manage an allergic reaction should it occur. Seek medical care immediately if you develop any of these symptoms.

What should you do before coming to the clinic?

• Wear a short-sleeve shirt or top with sleeves that are easy to roll up.
• To help prevent feeling faint while being vaccinated, have something to eat before coming to the clinic.
• Be sure to adhere to public health measures as advised with regards to preventing infections at the clinic.
• Bring any identification required by the clinic, such as your health card and your immunization record.
• If you suspect you have mpox, you should avoid contact with others and consult a health care provider or public health unit for advice. If mpox is ruled out, a vaccine may be recommended.

What should you do after receiving the vaccine?

• You will be asked to wait at least 15 minutes after receiving the vaccine to be sure you are feeling well. Longer waiting times of 30 minutes may be recommended if there is concern about a possible vaccine allergy. Inform a health care provider right away if you feel unwell while waiting. You should not leave the clinic for at least 15 to 30 minutes after receiving your vaccine, based on the recommendation of the health care provider, and should not leave if you are feeling unwell.
• If you have left the clinic, call 9-1-1 right away if you develop any serious symptoms or symptoms of an allergic reaction such as hives (bumps on the skin that are often very itchy), swelling of your face, tongue or throat, or difficulty breathing.
• Inform your health care provider or public health unit in your community of any concerning side effects after receiving the vaccine.
• If possible, wait at least 2 weeks after completing your Imvamune vaccination series before starting drugs that suppress your immune system, as recommended by your health care provider.
• Immunity from the vaccine takes about 2 weeks to build-up. The likelihood of being protected after the second dose is better than after the first dose. It is still possible to develop an mpox infection if you've received 2 doses of mpox vaccine. Therefore, you should avoid contact with someone who has or may have mpox. If a person has mpox, contact should be avoided until the person's scabs have fallen off and the skin is healed.
• Continue to follow safer sex practices (such as condom use and regular testing for sexually transmitted infections) which can help protect you and your partner or partners from a number of other sexually transmitted infections.
• Keep your immunization record with information about the Imvamune vaccine in a safe place.

When should I return for my next dose of Imvamune?

• Two doses of Imvamune are recommended with at least 28 days between doses. If you are overdue for your second dose, you should try to get it as soon as possible.
• Bring your immunization record with you when you come for your next dose.
• Tell the person providing the second dose about any side effects you experienced after the first dose.

If you have any questions, please speak with the person providing the vaccine or contact your health care provider or local public health unit.

Download in Word format the sample consent form (109 KB)

Imvamune vaccine has been authorized by Health Canada for active immunization against smallpox, mpox and related orthopoxvirus infection and disease under the provision of the Extraordinary Use New Drug (EUND) regulations in individuals 18 years of age and older determined to be at high risk for exposure. All vaccines, including EUND vaccines, continue to be monitored closely for clinical safety and effectiveness once they are in use by the public.

1. Last name:
2. First name:
3. Health card number or First Nations Status Card Number:
4. Phone number:
5. Email address:
6. Street address:
7. City:
8. Province:
9. Postal code:
10. Date of birth:
    • Month
    • Day
    • Year
11. Age:
12. Gender or Sex: (insert options per data collection preferences)
13. How many doses of smallpox/mpox vaccine(s) have you had before?
    • None
    • One
    • Two
14. If you have previously received a smallpox/mpox vaccine, specify the name and date of the previous smallpox/mpox vaccine(s) you have received, if known.
    • Name of vaccine:
    • Date: (month / day / year)
    • Name of vaccine:
    • Date: (month / day / year)
15. Do you have or have you had an mpox infection?
    • No
    • Yes
    • Uncertain
    • If yes, please provide details including when the symptoms started, if known.
    • If uncertain, please indicate what symptoms you have and when they started.
16. Are you feeling ill today?
    • No
    • Yes
    • If yes, please provide details
17. If you have had 1 or more previous smallpox or mpox vaccines, did you have any side effects after any previous dose(s) (including allergic reactions)?
    • No
    • Yes
    • If yes, please provide details
18. Are you allergic to eggs?^{Footnote 1}
    • No
    • Yes
    • If yes, please provide details
19. Are you known or suspected to be allergic to tromethamine (trometamol, Tris)^{Footnote 2}, benzonase^{Footnote 3}R, gentamicin^{Footnote 4} or ciprofloxacin^{Footnote 4} which are contained in the Imvamune vaccine?
    • No
    • Yes
    • If yes, please provide details
20. Are you or could you be pregnant or are you breastfeeding?
    • No
    • Yes
    • Uncertain
21. Do you have any problems with your immune system or are you taking any medications that can affect your immune system (for example, high dose steroids, chemotherapy, some arthritis medications)?
    Ask the health care provider if you are not sure about your medical conditions.
    • No
    • Yes
    • Uncertain
    • If yes, please provide details
22. Have you ever felt faint or fainted after a past vaccination or medical procedure?
    • No
    • Yes
    • If yes, please provide details

I have read (or it has been read to me) and I understand the "Information sheet for Imvamune (smallpox/mpox) vaccine". I have had the opportunity to ask questions and to have them answered to my satisfaction. I consent to receiving the Imvamune vaccine.

• Signature:
• Print name:
• Date of signature:
• If signing for someone other than yourself, indicate your relationship to that other person:

I confirm that I am the parent or legal guardian or substitute decision maker.

Download in Word format the sample after care sheet (98 KB)

What should I do right after receiving the vaccine?

• Wait for at least 15 minutes after receiving your vaccine. Longer waiting times of 30 minutes may be recommended if there is concern about a possible vaccine allergy. Though uncommon, fainting or allergic reactions can occur after vaccination. Symptoms of an allergic reaction include hives (bumps on the skin that are often very itchy), swelling of your face, tongue or throat, or difficulty breathing. The clinic staff are prepared to manage these events should they occur.
• Immediately inform a health care provider at the clinic if you feel unwell while waiting. Do not leave the clinic if you are feeling unwell.
• Do not operate a vehicle or other form of transportation for at least 15 to 30 minutes after being vaccinated (as advised by the health care provider) or if you are feeling unwell.

What should I expect in the next few days?

• Side effects can develop in the few days after receiving the Imvamune vaccine. Although most of these side effects are not serious to your health, they may make you feel unwell for a few days. They will go away on their own.
  • The most common side effects are pain, redness and swelling where the injection was given. A cool, damp cloth or wrapped ice pack where the vaccine was given may help.
  • Other symptoms may include tiredness, headache, muscle aches or pain, chills and nausea.
  • If needed, pain medication (such as acetaminophen) may help with pain. Check with your health care provider or local public health unit if you need advice about medication.
• Serious side effects after receiving the vaccine are rare. However, should you develop any serious symptoms or symptoms that could be an allergic reaction, call 9-1-1 right away. Symptoms of an allergic reaction include:
  • difficulty breathing
  • hives (bumps on the skin that are often very itchy)
  • swelling of the face, tongue or throat
• If you have any concerns about the symptoms you develop after receiving the vaccine, contact your health care provider or local public health unit for advice. Any serious side effects after vaccination should be reported to your local public health unit.
• If you need another dose of Imvamune vaccine, tell the person providing the next dose about any side effects you may have experienced.

When will I get the protective benefits from the vaccine?

• Immunity from the vaccine takes about 2 weeks to build-up. The likelihood of being protected after the second dose is better than after the first dose. It is still possible to develop an mpox infection if you've received 2 doses of mpox vaccine. Therefore, you should avoid contact with someone who has or may have mpox. If a person has mpox, contact should be avoided until the person's scabs have fallen off and the skin is healed.
• Continue to follow safer sex practices (such as condom use and regular testing for sexually transmitted infections) which can help protect you, your partner or partners from a number of other sexually transmitted infections.

When should I return for my next dose of vaccine?

• Two doses of Imvamune are recommended with at least 28 days between doses. If you are overdue for your second dose, you should try to get it as soon as possible.
• Bring your immunization record with you for your next dose. Tell the person providing the vaccine about any side effects you experienced after previous dose.

Things to remember

• If possible, wait at least 2 weeks after completing your vaccination series before starting drugs that suppress your immune system, as recommended by your health care provider.
• Immunity from the vaccine takes about 2 weeks to build-up. The likelihood of being protected after the second dose is better than after the first dose. It is still possible to develop an mpox infection if you've received 2 doses of mpox vaccine. Therefore, you should avoid contact with someone who has or may have mpox. If a person has mpox, contact should be avoided until the person's scabs have fallen off and the skin is healed.
• Continue to follow safer sex practices (such as condom use and regular testing for sexually transmitted infections) which can help protect you, your partner or partners from a number of other sexually transmitted infections.
• Keep this sheet or other immunization record in a safe place.

Immunization record

• Name:
• Date of birth (month / day / year):
• Health card number or First Nations Status Card Number: