Smallpox vaccine contains live vaccinia virus (not smallpox virus) to protect against smallpox. This same vaccine has been given to millions of Americans, including Service members during World War I, World War II, and until the 1980s. Between December 2002 and January 2008, more than 1.4 Million Service members received smallpox vaccination.
The vaccine is made from a virus called vaccinia, which is another "pox"-type virus related to smallpox. The vaccine helps the body develop immunity to smallpox. The vaccine does not contain the smallpox virus and cannot spread smallpox. The vaccine was successfully used to eradicate smallpox from the human population.
The vaccine virus (vaccinia) is similar to the smallpox virus (variola). Edward Jenner reported in 1796 that people given vaccinia (smallpox) vaccine become protected from smallpox. Smallpox vaccine was the very first vaccine and has been used successfully for over 200 years.
Getting smallpox vaccine before exposure will protect about 95 percent of people from getting smallpox. Vaccination within 3 days after exposure will prevent or significantly lessen the severity of smallpox symptoms in the vast majority of people. Vaccination 4 to 7 days after exposure likely offers some protection from disease or may modify the severity of disease. Vaccination after this time may not offer any benefit.
Both Dryvax and ACAM2000 are derived from the New York City Board of Health strain using a pox virus called vaccinia, but Dryvax was grown on the skin of calves and essentially freeze-dried for storage. Dryvax was licensed and approved by the FDA, in 1931 and is now in limited supply because it is no longer manufactured.
ACAM2000, Smallpox (Vaccinia) Vaccine, Live, approved by FDA in 2007, is a live vaccinia virus derived from plaque purification cloning from Dryvax®, grown in African Green Monkey kidney (Vero) cells, and tested to be free of adventitious agents.
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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 - 5.0x108 PFU/mL or 2.5-12.5x105 PFU/dose.
Diluent for ACAM2000 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.
Prior to reconstitution, ACAM2000 vaccine retains a potency of 1.0x108 PFU or higher per dose for at least 18 months when stored at refrigerated temperatures of 2-8°C (36-46°F).
After reconstitution, ACAM2000 vaccine may be administered during a 6 to 8 hour workday at room temperature (20-25°C, 68-77°F). Do not expose ACAM2000 to room temperature conditions for more than 48 hours. 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.
Diluent for Smallpox Vaccine, (Vero Cells) Lyophilized, ACAM2000 should be stored in a refrigerator (2-8°C, 36-46°F). ACAM2000 contains live vaccinia virus that is transmissible, and should be handled as an infectious agent once vials are opened.
The vaccine contains 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, 0.3 mLs.
Smallpox vaccination of US military forces dates back to 1812. Smallpox vaccine has been given to millions of Americans, including Service members during World War I, World War II, and into the 1980s.
In the United States, routine vaccination against smallpox ended around 1972 in most places. Military smallpox vaccination programs continued longer. In 1984, routine military vaccinations were limited to recruits entering basic training. Between 1984 and 1989, some service members were immunized but not others. In 1990, the Department of Defense discontinued routine vaccination of recruits.
Between December 2002 and January 2008 more than 1.4 M Service members received smallpox vaccination.