Vaccine Information: ACAM2000 (Page 5 of 6)

15 REFERENCES

1.
Fulginiti VA, Papier A, Lane JM, Neff JM, Henderson, DA. Smallpox vaccination: a review, part 1. background, vaccination technique, normal vaccination and revaccination, and expected normal reactions. Clin Infect Dis. 2003;37:241-250.
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Centers for Disease Control and Prevention. Notice to readers: Supplemental recommendations on adverse events following smallpox vaccine in the pre-event vaccination program: recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2003;52(13):282-284.
3.
Lane J, Millar J. Risks of smallpox vaccination complications in the United States. Am J Epidemiol. 1971;93:238-240.
4.
Lane, JM, Ruben FL, Neff JM, Millar JD. Complications of smallpox vaccination, 1968: results of ten statewide surveys. J Infect Dis. 1970;122(4):303-309.
5.
Poland GA, Grabenstein JD, Neff JM. The US smallpox vaccination program: a review of a large modern era smallpox vaccination implementation program. Vaccine. 2005;23:2078-2081.
6.
Casey GC, Iskander JK, Roper MH, Mast EE, Wen X-J, Torok TJ, et al..Adverse events associated with smallpox vaccination in the United States, January-October 2003. JAMA. 2005;94(21):2734-2743.
7.
Centers for Disease Control and Prevention.Update: Cardiac and other adverse events following civilian smallpox vaccination – United States, 2003. MMWR Morb Mortal Wkly Rep. 2003;52(27):639-42.
8.
Centers for Disease Control and Prevention. Cardiac adverse events following smallpox vaccination – United States, 2003. MMWR Morb Mortal Wkly Rep. 2003; 52(12):248-50.
9.
Centers for Disease Control and Prevention. Update: adverse events following smallpox vaccination – United States, 2003. MMWR Morb Mortal Wkly Rep. 2003; 52(13):278-282.
10.
Neff JM, Lane JM, Pert JH, Moore R, Millar JD, Henderson DA. Complications of smallpox vaccination. National survey in the United States, 1963. N Engl J Med. 1967;276:125-132.
11.
Centers for Disease Control and Prevention. Recommendations for Using Smallpox Vaccine in a Pre-event vaccination Program. Supplemental Recommendation of the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC). MMWR 2003;52 (No. RR-7).
12.
Centers for Disease Control and Prevention.Notice to Readers. National smallpox vaccine in pregnancy registry. MMWR Morb Mortal Wkly Rep. 2003;52(12):256.
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Centers for Disease Control and Prevention. Vaccinia (smallpox) vaccine recommendation of the Advisory Committee in Immunization Practices (ACIP). 2001. MMWR Morb Mortal Wkly Rep. 2001;50 (RR10):1-25.
14.
Sejvar J, Labutta RJ, Chapman LE, Grabenstein JD, Iskander J. Lane JM. Neurological adverse events associated with smallpox vaccination in the United States, 2002-2004. JAMA. 2005;294(24):2744-50.
15.
Nagao S, Inaba S, Iijima S. Langerhans cells at the sites of vaccinia virus inoculation. Arch Dermatol Res. 1976;256(1):23-31.
16.
Cole, G. Blanden R. Immunology of poxviruses. In. Nahmias AJ, O’Reilly RJ, eds Comprehensive Immunology, Immunology of Human Infection, Part II, Viruses and Parasites. Vol 9 New York, NY: Plenum; 1982:1-19.
17.
Mack TM, Noble J, Thomas DB. A Prospective Study of Serum Antibody and Protection Against Smallpox. Am. J Trop Med & Hygiene. 1972: 21(2):214-218.
18.
Department of Defense Directive. Number 6205.3 DoD immunization program for biological warfare defense. 1993. Available from http://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodd/620503p.pdf. Accessed February 28, 2018.
19.
Centers for Disease Control and Prevention. Recommendations for use of smallpox vaccine for bioterrorism preparedness and response. Available from https://www.cdc.gov/smallpox/bioterrorism-response-planning/index.html. Accessed May 30, 2017.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

ACAM2000, Smallpox (Vaccinia) Vaccine, Live, is supplied in multiple-dose 3 mL clear glass vials containing lyophilized powder (freeze‑dried vaccine). After reconstitution with 0.3 mL of diluent, the vial contains approximately 100 nominal doses of 0.0025 mL of vaccinia virus (live), 1.0 — 5.0×108 PFU/mL or 2.5-12.5×105 PFU/dose.

Diluent for ACAM2000, 50% (v/v) Glycerin USP, 0.25% (v/v) Phenol USP in Water for Injection USP, is supplied in 3 mL clear glass vials containing 0.6 mL of diluent.

Bifurcated needles are supplied in boxes (5 x 5 x 1 in) containing 100 needles.

1 mL tuberculin syringes with 25 gauge x 5/8” needles are supplied for vaccine reconstitution.

Both the vaccine and diluent vial stoppers are not made with natural rubber latex.

16.2 Storage and Handling

ACAM2000 should be stored in a freezer with an average temperature of -15°C to -25°C (+5°F to -13°F).

Prior to reconstitution, ACAM2000 vaccine retains a potency of 1.0×108 PFU or higher per dose for at least 18 months when stored at refrigerated temperatures of +2-8°C (36-46°F).

During shipment, ACAM2000 should be maintained at a temperature of ‑10°C or colder.

After reconstitution, ACAM2000 vaccine may be administered during a 6 to 8 hour workday at room temperature (20-25°C, 68-77°F). Reconstituted ACAM2000 vaccine may be stored in a refrigerator (2-8°C, 36-46°F) no longer than 30 days, after which it should be discarded [see Dosage and Administration (2.3) ]. Diluent for Smallpox Vaccine, (Vero Cells) Lyophilized, ACAM2000 should be stored at room temperature (15-30°C, 59-86°F).

ACAM2000 contains live vaccinia virus that is transmissible, and should be handled as an infectious agent once vials are open. See 2.1 [Instructions for Vaccine Preparation] and 2.2 [Preparation / Handling Precautions and Instructions for Disposal] for details on handling and disposal.

17 PATIENT COUNSELING INFORMATION

Please refer patient to the FDA-approved Medication Guide prepared for ACAM2000 Smallpox Vaccine.

17.1 Serious Complications of Vaccination

Patients must be informed of the major serious adverse events associated with vaccination, including myocarditis and/or pericarditis, progressive vaccinia in immunocompromised persons, eczema vaccinatum in persons with skin disorders, auto- and accidental inoculation, generalized vaccinia, urticaria, erythema multiforme major (including Stevens-Johnson syndrome) and fetal vaccinia in pregnant women.

17.2 Protecting Contacts at Highest Risk for Adverse Events

Patients must be informed that they should avoid contact with individuals at high risk of serious adverse effects of vaccinia virus, for instance, those with past or present eczema, immunodeficiency states including HIV infection, pregnancy, or infants less than 12 months of age.

17.3 Self-inoculation and Spread to Close Contacts

Patients must be advised that virus is shed from the cutaneous lesion at the site of inoculation from approximately Day 3 until scabbing occurs, typically between Days 14-21 after primary vaccination. Vaccinia virus may be transmitted by direct physical contact. Accidental infection of skin at sites other than the site of intentional vaccination (self-inoculation) may occur by trauma or scratching. Contact spread may also result in accidental inoculation of household members or other close contacts. The result of accidental infection is a pock lesion(s) at an unwanted site(s) in the vaccinee or contact, and resembles the vaccination site. Self-inoculation occurs most often on the face, eyelid, nose, and mouth, but lesions at any site of traumatic inoculation can occur. Self-inoculation of the eye may result in ocular vaccinia, a potentially serious complication.

17.4 Care of the Vaccination Site and Potentially Contaminated Materials

Patients must be given the following instructions:

The vaccination site must be completely covered with a semipermeable bandage. Keep site covered until the scab falls off on its own.
The vaccination site must be kept dry. Normal bathing may continue, but cover the vaccination site with waterproof bandage when bathing. The site should not be scrubbed. 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 subsequently touch other parts of the body particularly the eyes, anal and genital areas that are susceptible to accidental (auto-) inoculation.
After changing the bandage or touching the site, wash hands thoroughly with soap and water or >60% alcohol-based hand-rub solutions.
To prevent transmission to contacts, physical contact of objects that have come into contact with the lesion (e.g. soiled bandages, clothing, fingers) must be avoided.
Wash separately clothing, towels, bedding or other items that may have come in direct contact with the vaccination site or drainage from the site, using hot water with detergent and/or bleach. Wash hands afterwards.
Soiled and contaminated bandages must be placed in plastic bags for disposal.
The vaccinee must wear a shirt with sleeves that covers the vaccination site as an extra precaution to prevent spread of the vaccinia virus. This is particularly important in situations of close physical contact.
The vaccinee must change the bandage every 1 to 3 days. This will keep skin at the vaccination site intact and minimize softening.
Don’t put salves or ointments on the vaccination site.
When the scab fall off, throw it away in a sealed plastic bag and wash hands afterwards.

Manufactured by

Emergent Product Development Gaithersburg Inc.
Gaithersburg, MD USA 20879
License No. 2089

Any and all Emergent BioSolutions Inc. brand, product, service and feature names, logos and slogans are trademarks or registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other countries. All rights reserved.

Medication Guide

Smallpox (Vaccinia) Vaccine, Live

ACAM2000®

Please read this Medication Guide before you receive a vaccination with ACAM2000. This Guide does not take the place of talking to your healthcare provider about ACAM2000 and the smallpox disease.

What is the most important information I should know about
the ACAM2000 smallpox vaccine?

If you are at a high risk for being exposed to smallpox, you should be vaccinated even if you have health problems, unless you have certain problems with your immune system. People who have health problems may have a higher chance of getting serious side effects from vaccination but are also those who have a higher chance of dying from the smallpox disease.
ACAM2000 may cause serious heart problems called myocarditis and pericarditis, or swelling of the heart tissues. In studies, about 1 in every 175 persons who got the vaccine for the first time may have experienced myocarditis and/or pericarditis. On rare occasions these conditions can result in an irregular heart beat and death. Your chances of getting heart problems from the vaccine are lower if you have already had this vaccine before. You can have myocarditis and/or pericarditis even if you have no symptoms. Call your healthcare provider or get emergency help right away if you have:
chest pain or pressure
fast or irregular heartbeat
breathing problems
See “What are the possible side effects of ACAM2000?
Because the vaccine has a live virus, it can spread to other parts of your body or to other people if you touch the vaccination site and then touch other parts of your body or other people. The vaccine virus can spread until the vaccination scab falls off (2 to 4 weeks after vaccination). If the virus is spread to a person who should not get the vaccine, the side effects can be very serious and life-threatening.
See “How do I care for the smallpox vaccination site?

What is the ACAM2000 smallpox vaccine?

ACAM2000 is a prescription vaccine used to protect people against smallpox disease. It is for use in people who have a high chance of getting the disease.

ACAM2000 contains live vaccinia virus (a “pox”-type virus) to protect against smallpox disease.

Who should not get the ACAM2000 smallpox vaccine?

In an emergency, you should be vaccinated if you are at high risk for getting smallpox disease even if you have health problems (except if you have certain problems with your immune system as discussed below).
Your healthcare provider may not give you ACAM2000 if you have problems with your immune system. You may have immune system problems if you:
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
How do I receive ACAM2000?
ACAM2000 smallpox vaccine is not a shot like other vaccines. Your healthcare provider will make 15 pokes in the skin of your upper arm with a needle containing ACAM2000. The pokes are not deep, but will cause a drop of blood to form. This is called the vaccination site.
It is important to care for the vaccination site properly so that the virus doesn’t spread to other parts of your body or to other people. You can infect another part of your body or other people until the scab falls off.

It is important to ALWAYS:

1.
Wear bandages to cover the entire vaccination site.
2.
Wear sleeves to cover the site.
3.
Wash your hands, wash your hands, wash your hands.

How do I care for the ACAM2000 vaccination site?

When changing bandages or caring for your vaccination site, wear gloves. Use an absorbent bandage to completely cover your vaccination site.
Change your bandage when it begins to soak through (at least every 1 to 3 days).
Throw away gloves and used bandages in sealed or double plastic bags. A small amount of bleach can be added to the bag to kill the virus.
Wear clothes with sleeves to cover the site and prevent scratching the vaccination site. It is especially important to wear a bandage and sleeves to bed to avoid scratching.
Wash your hands frequently with alcohol-based cleansers or soap and water.
Be sure to wash your hands each time you change your bandage or if you touch the vaccination site.
Do not use creams or ointments on the vaccination site because they will delay healing and can spread the virus.
Do not scratch or pick at the vaccination site.
You can take a bath or shower, but don’t touch or scrub the vaccination site.
It is best to cover the vaccination site with a waterproof bandage.
If the vaccination site gets wet, dry the site with toilet paper and flush it. (Do not use a cloth towel because it can spread the virus.)
Cover the vaccination site with a loose gauze bandage after bathing to allow it to dry out.
Do not use a bandage that blocks air from the vaccination site. This could cause the skin at the vaccination site to soften and wear away.
If you exercise enough to cause sweat to drip, use a waterproof bandage on the vaccination site when exercising.
Wash clothing, towels, bedding or other items that may have come in contact with the vaccination site separately from other wash. Use hot water with detergent and bleach.
When the scab falls off, throw it away in a sealed plastic bag with a small amount of bleach. Wash your hands afterwards.

What should I expect at the vaccination site and in the weeks following vaccination?

If vaccination is successful, a red and itchy bump forms at the vaccination site in 2 to 5 days. Over the next few days, the bump becomes a blister and fills with pus. During the second week, the blister dries up and a scab forms. The scab falls off after 2 to 4 weeks, leaving a scar. People vaccinated for the first time may have a larger reaction than those being revaccinated. See expected responses below:

Smallpox Vaccination Site:
expected response after vaccination

M:\RA\ectd\SPL\Labels\ACAM\April 2018\MedGuide Image 1 expected response.jpg
See also: https://www.cdc.gov/smallpox/clinicians/comparison-vaccinees-images.html

Note: After 6 to 8 days, check to be sure that your vaccination site looks like one of the pictures above. If it does not look like this, see your healthcare provider because you may need to be revaccinated.

If you need medical care in the month after your vaccination, tell your healthcare provider you just got a smallpox vaccination.
Certain people, such as laboratory workers who work with smallpox, are at risk of being exposed to smallpox over a long period of time. These people may need a booster vaccination every 3 years to maintain protection against smallpox.

What should I avoid after getting vaccinated with the ACAM2000 smallpox vaccine?

For 4 weeks after vaccination AND until the vaccination site has healed, you should avoid:
getting pregnant. Smallpox vaccine may rarely cause infection in an unborn baby if the mother is vaccinated during pregnancy. This infection usually results in stillbirth or death.
handling babies or breastfeeding.
swimming or hot tub use.
donating blood.
Tuberculin (TB) testing. Smallpox vaccine may cause the TB test to give the wrong result.
Avoid rubbing, scratching or touching the vaccination site.
Until the vaccination scab falls off, do NOT:
have contact with people who cannot get the vaccine to prevent accidental spread of the vaccine virus. This includes physical contact and household contact. If there is someone in your household who should not get the vaccine, such as a pregnant woman, an infant, or someone who has an illness, you should not stay in the house until the vaccination scab falls off.
share a bed, clothes, towels, linen, or toiletries with unvaccinated people.

Don’t scratch that itch:

Vaccine virus can accidentally spread

to a family member, close contact,

or another part of your body.

MedGuide Image 1 infected arm.jpg
(click image for full-size original)
MedGuide Image 2 Infected eye.jpg
(click image for full-size original)
We don’t know if the vaccine virus can be spread to cats, dogs, or other household pets, or whether pets can spread the virus to other people in the household. Try to keep the vaccine virus from reaching your pet. See “How do I care for the smallpox vaccination site?”

What are the possible side effects of ACAM2000?

ACAM2000 may cause serious heart problems, including myocarditis and pericarditis. This can happen within 3 to 4 weeks after you get the vaccine. Call your healthcare provider or get emergency help right away if you have:

chest pain or pressure
fast or irregular heartbeat
breathing problems

Most people who get myocarditis and/or pericarditis seem to get better after a few weeks. But heart problems may last longer in some people, and in rare cases, could lead to death.

Other serious side effects include:

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 causing watery painful eyes and blurred vision, scarring of the cornea, and blindness)

Common side effects include:

itching
swollen lymph nodes
sore arm
fever
headache
body ache
mild rash
fatigue

The risks for serious vaccine side effects are greater for people who:

have skin problems called eczema or atopic dermatitis
have skin problems, such as burns, impetigo, contact dermatitis, chickenpox, shingles, psoriasis, or uncontrolled acne
have had heart problems
have serious heart or blood vessel problems including angina, previous heart attack, artery disease, congestive heart failure, stroke, or other cardiac problems
smoke or have high blood pressure, high cholesterol, diabetes, high blood sugar, or a family history of heart problems
are breastfeeding
are pregnant, could be pregnant, or plan to become pregnant
are less than 1 year old
are taking steroid eye drops or ointment
have had problems after previous doses or are allergic to ACAM2000 or any part of ACAM2000 such as antibiotics neomycin or polymyxin B
Tell your healthcare provider if you have any of the above conditions.
The virus from your vaccination can spread to other people and cause serious side effects. It is important to tell your healthcare provider if you:
live or work with a person who has skin problems (like eczema, dermatitis, burns, psoriasis, bad acne) or is suffering from impetigo, chickenpox or shingles
live or have close contact with a baby, or a person who is pregnant or breastfeeding
live or have close contact with a person who has an immune deficiency or cardiac disease
See “How do I care for the ACAM2000 vaccination site?”

Tell your healthcare provider about any side effect that bothers you or that does not go away.

To report SUSPECTED SIDE EFFECTS (ADVERSE REACTIONS), contact Emergent BioSolutions at 1-877-246-8472 and productinquiries@ebsi.com or

VAERS at 800-822-7967 and https://vaers.hhs.gov

General information about the safe and effective use of ACAM2000

This Medication Guide provides a summary of the most important information about ACAM2000. Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. If you would like more information or have any questions, talk to your healthcare provider. You can ask your healthcare provider for information about ACAM2000 that is written for healthcare professionals. The vaccine should not be used for a condition other than that for which it is prescribed.

What are the ingredients in ACAM2000?

ACAM2000: live vaccinia virus derived from plaque purification cloning from Dryvax® (Wyeth Laboratories, Marietta, PA, calf lymph vaccine, New York City Board of Health Strain) and grown in African Green Monkey kidney (Vero) cells

Inactive ingredients: 6-8 mM HEPES (pH 6.5-7.5), 2% human serum albumin USP, 0.5 – 0.7% sodium chloride USP, 5% mannitol USP, and trace amounts of the antibiotics neomycin and polymyxin B

Diluent for ACAM2000: 50% (v/v) Glycerin USP, 0.25% (v/v) Phenol USP in Water for Injection USP

Any and all Emergent BioSolutions Inc. brand, product, service and feature names, logos and slogans are trademarks or registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other countries. All rights reserved.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

LBL040018-1.0

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