Acam2000: Smallpox Vaccine, Live: patient information, prescribing information, ingredients, manufacturer, adverse reactions and side effects

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all information needed to use ACAM2000 safely and effectively. See full prescribing information for ACAM2000.

See full insert sheet at this link at the Natural News Reference website.

ACAM2000, (Smallpox (Vaccinia) Vaccine, Live)

Lyophilized preparation for percutaneous scarification

Initial U.S. Approval: 2007

INGREDIENTS AND EXCIPIENTS

ACAM2000 is provided as a lyophilized preparation of purified live virus containing the following non-active excipients: 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 neomycin and polymyxin B.

ACAM2000 is provided as a lyophilized preparation of purified live virus containing the following non-active excipients: 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 neomycin and polymyxin B.

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

After reconstitution, each vial of ACAM2000 vaccine contains approximately 100 doses (0.0025 mL/dose). The concentration of vaccinia virus is 1.0-5.0 x 108 plaque-forming units (PFU)/mL or 2.5-12.5 x 105 PFU/dose determined by plaque assay in Vero cells. ACAM2000 is administered by the percutaneous route (scarification) using 15 jabs of a stainless steel bifurcated needle that has been dipped into the vaccine.

INDICATIONS AND USAGE

ACAM2000® is indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.

DOSAGE AND ADMINISTRATION

– Administer ACAM2000 only after being trained on the safe and effective administration of the vaccine by the percutaneous route (scarification). (2.3)

– A droplet of ACAM2000 is administered by the percutaneous route (scarification) using 15 jabs of a bifurcated needle. ACAM2000 should not be injected by the intradermal, subcutaneous, intramuscular, or intravenous route. (2.3)

– The droplet (0.0025 mL) of reconstituted vaccine is picked up with a bifurcated needle by dipping needle into ACAM2000 vial. (2.3)

– See full prescribing information for instructions for vaccine preparation (2.2), administration including provision of the Medication Guide to vaccinees and instruction to vaccinees about vaccination site care, (2.3) and interpretation of response to vaccination. (2.4)

– Re-vaccination may be recommended (e.g. every 3 years). (2.5)

DOSAGE FORMS AND STRENGTHS

Lyophilized powder reconstituted with packaged diluent. After reconstitution, each vial has approximately 100 doses of 0.0025 mL of live vaccinia virus containing 2.5 – 12.5 x 105 plaque forming units. (3)

CONTRAINDICATIONS

Individuals with severe immunodeficiency who are not expected to benefit from the vaccine. These individuals may include persons who are undergoing bone marrow transplantation or persons with primary or acquired immunodeficiency states who require isolation (4).

WARNINGS AND PRECAUTIONS

– Myocarditis and/or pericarditis, ischemic heart disease and non-ischemic dilated cardiomyopathy. (5.1, 5.2)

– Encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia (vaccinia necrosum), generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson syndrome), eczema vaccinatum, fetal vaccinia and fetal death. (5.1)

– Ocular vaccinia and blindness. (5.3)

– These risks, including risks of severe disability and/or death, are increased in vaccinees with:

– Cardiac disease (5.2).

– Eye disease treated with topical steroids. (5.3)

– Congenital or acquired immune deficiency disorders. (5.4)

– History or presence of eczema and other skin conditions. (5.5)

– Infants < 12 months of age. (5.6)

• Pregnancy (5.7)

ACAM2000 is a live vaccinia virus that can be transmitted to persons who have close contact with the vaccinee and the risks in contacts are the same as those stated for vaccinees. (5.10)

ADVERSE REACTIONS

Common adverse events include inoculation site signs and symptoms, lymphadenitis, and constitutional symptoms, such as malaise, fatigue, fever, myalgia, and headache (6.1). These adverse events are less frequent in revaccinated persons than persons receiving the vaccine for the first time.

Inadvertent inoculation at other sites is the most frequent complication of vaccinia vaccination. The most common sites involved are the face, nose, mouth, lips, genitalia and anus.

Self-limited skin rashes not associated with vaccinia replication in skin, including urticaria and folliculitis, may occur following vaccination.

To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur. at 1-800-822-2463 (1-800-VACCINE) or VAERS at 800-822-7967 and https://vaers.hhs.gov.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category D: ACAM2000 has not been studied in pregnant women. Live vaccinia virus vaccines can cause fetal harm when administered to a pregnant woman. Congenital infection, principally occurring during the first trimester, has been observed after vaccination with live vaccinia smallpox vaccines, although the risk may be low. Generalized vaccinia of the fetus, early delivery of a stillborn infant, or a high risk of perinatal death has been reported.

The only setting in which vaccination of pregnant women should be considered is when exposure to smallpox is considered likely. If this vaccine is used during pregnancy, or if the vaccinee lives in the same household with or has close contact with a pregnant women, the vaccinee should be apprised of the potential hazard to the fetus. Healthcare providers, state health departments, and other public health staff should report to the National Smallpox Vaccine in Pregnancy Registry all pregnant women who, from 42 days prior to conception onward, received ACAM2000 or had close contact with a person who received ACAM2000 within the previous 28 days.. Civilian women should contact their healthcare provider or state health department for help enrolling in the registry. All civilian and military cases should be reported to the DoD, telephone 619 553-9255, Defense Switched Network (DSN) 553-9255, fax 619 533-7601 or e-mail [email protected].

Nursing Mothers

ACAM2000 has not been studied in lactating women. It is not known whether vaccine virus or antibodies are secreted in human milk. Live vaccinia virus can be inadvertently transmitted from a lactating mother to her infant. Infants are at high risk of developing serious complications from live vaccinia smallpox vaccination.

Pediatric Use

The safety and effectiveness of ACAM2000 have not been established in the age groups from birth to age 16. The use of ACAM2000 in all pediatric age groups is supported by evidence from the adequate and well-controlled studies of ACAM2000 in adults and with additional historical data with use of live vaccinia virus smallpox vaccine in pediatrics. Before the eradication of smallpox disease, live vaccinia virus smallpox vaccine was administered routinely in all pediatric age groups, including neonates and infants, and was effective in preventing smallpox disease. During that time, live vaccinia virus was occasionally associated with serious complications in children, the highest risk being in infants younger than 12 months of age. [See Warnings and Precautions (5.6)].

Geriatric Use

Clinical studies of ACAM2000 did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. There are no published data to support the use of this vaccine in geriatric (persons >65 years) populations.

Revised: [12/2015]

https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM142572.pdf

http://naturalnewsreference.com/vaccine-insert-sheets/Acam2000.pdf