Initial U.S. Approval: 2007
ACAM2000® is indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.
WARNINGS AND PRECAUTIONS
– Myocarditis and/or pericarditis, ischemic heart disease and non-ischemic dilated cardiomyopathy.
– 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.
– Ocular vaccinia and blindness.
These risks, including risks of severe disability and/or death, are increased in vaccinees with:
– Cardiac disease
– Eye disease treated with topical steroids.
– Congenital or acquired immune deficiency disorders.
– History or presence of eczema and other skin conditions.
– Infants < 12 months of age.
– Pregnancy
ACAM2000 is a live vaccinia [cowpox] 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.
Death has also been reported in unvaccinated contacts accidentally infected by individuals who have been vaccinated.
Ischemic cardiac events, including fatalities, have been reported following smallpox vaccination…
[S]ubjects who have been diagnosed with 3 or more of the following risk factors… 1) high blood pressure; 2) elevated blood cholesterol; 3) diabetes mellitus or high blood sugar; 4) first degree relative… who had a heart condition before the age of 50; or 5) smoke cigarettes may have increased risks.
Persons with eczema of any description such as, atopic dermatitis, neurodermatitis, and other eczematous conditions, regardless of severity of the condition, or persons who have a history of these conditions at any time in the past, are at higher risk of developing eczema vaccinatum.
Pregnant women who are close contacts of vaccinees may be at increased risk because live vaccinia virus can shed and be transmitted to close contacts.
ACAM2000 contains neomycin and polymyxin B [antibiotics]. Persons allergic to these components may be at higher risk for adverse events after vaccination.
Blood and organ donation should be avoided for at least 30 days following vaccination with ACAM2000.
Severe vaccine-related adverse events, defined as interfering with normal daily activities, in vaccinia-naïve subjects were reported by 10% of subjects…
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.
ACAM2000, Smallpox (Vaccinia) Vaccine, Live, is a live vaccinia virus derived from plaque purification cloning from Dryvax® (Wyeth Laboratories, Marietta, PA, calf lymph vaccine… and grown in African Green Monkey kidney (Vero) cells… [and also contains] 2% human serum albumin…
Smallpox vaccine does not contain smallpox virus (variola) and cannot spread or cause smallpox.
Vaccinia [cowpox] virus is a member of the same taxonomic group (the Orthopox genus) as smallpox (variola) virus, and immunity induced by vaccinia virus cross-protects against variola virus.