Smallpox vaccine administration

By early 2004, 15 million doses of smallpox vaccine, Dryvax, were available in the United States. Dryvax, a Wyeth product, is a live virus preparation of vaccinia. The vaccine comes as a lyophilized (freeze-dried) powder in 100 dose vials containing the antibiotics polymyxin B, streptomycin, tetracycline, and neomycin. Fifty percent glycerin, containing a small amount of phenol as a preservative, serves as the diluent for reconstitution (25). Studies have shown that diluting the vaccine in a 1 5 ratio could expand the supply without reducing vaccine efficacy (25). In addition, 200 million antibiotic-free doses are in production. The CDC Web site has detailed directions on how to reconstitute and administer the vaccine at http //www.bt.cdc.gov/agent/smallpox/vaccination/ administration.asp. 

Smallpox vaccine administration requires a bifurcated needle. Each bifurcated needle is sterile and individually wrapped. The vaccinator should first review the patient s history to ensure the patient has no contraindication to receiving the vaccine. However, dnring an ontbreak of smallpox, case contacts should receive the vaccine regardless of the contraindications, because the vaccine is safer than the disease. 

Vaccine liability issues were also covered in Section 304 of the Homeland Security Act (HSA) of 2002as amended in April 2003, in which Congress enacted liability protection for manufacturers of smallpox vaccines. Vaccine liability can be handled in four different ways the government can substitute itself as the defendant, it can decide nobody need be liable and provide no-fault compensation, it can indemnify manufacturers after they have been sued and lost, or it can alter the normal rules of litigation. In the HSA, the government substitutes itself as the defendant if the HHS Secretary declares an actual or potential bioterrorist incident or other actual or potential public health emergency makes advisable the administration of a covered countermeasure," such as a vaccine. Secretary Tommy Thompson issued the first such declaration on January 24, 2003. 

Contraindications Administration of live virus vaccines, especially smallpox vaccine hypersensitivity to corticosteroids or tartrazine peptic ulcer disease (except life-threatening situations) systemic fungal infection Topical Marked circulation impairment... 

Other types of replication-deficient viral vectors that have been used in the gene therapy field include Herpes simplex viral (HSV) vectors that (1) are able to transduce nondividing cells and (2) are highly infective for neurologic tissue and vaccinia vectors. Vaccinia vectors in turn (1) are able to transduce nondividing cells and (2) have the ability to efficiently infect many types of cells. The primary safety concerns for HSV vectors are the potential for tropism to the CNS and the potential for latency and reactivation. Vaccinia vectors contain the same backbone as the smallpox vaccine, thus the available safety databases for vaccinia administration in humans consist primarily of preventive vaccination in a healthy population. Principal safety concerns with the use of vaccinia vectors include (1) their ability to replicate in humans and possibly... 

Administration of smallpox vaccine and VIG. No contraindication to vaccination is likely to be recognized during an outbreak of smallpox (Bronze, Huycke, Machado, Voskuhl, Greenfield, 2002). 

Until recently, smallpox vaccine was approved by the U.S. Food and Drug Administration for use only in persons in special-risk categories, including laboratory... 

Demonstrate the safe administration of immunizations, including smallpox vaccination. 

Accidental administration of 10 doses of smallpox vaccine to an already vaccinated girl resulted in a clinical picture characterized by neuraxitis with general tonic-clonic convulsions. Complete cure was attained after treatment with hyperimmune antivaccinia globulins and methisazone (38). 

United States Department of Health and Human Services. Health Resources and Services Administration, Smallpox Vaccine Injury Compensation Program Administrative Implement, 42 CFR Part 102, Federal Register/Vol. 68, No. 241/Tuesday, December 16, 2003/Rules and Regulations, http //publichealthlaw.law.lsu.edu/blaw/hhs/42-crf-102.pdf, also at http //www. hrsa. gov/S mallpoxinj ury/frn 121603. htm... 

Vaccination against infectious illnesses provides unseen protection against contagious diseases—afflictions causing permanent disability or even death. Vaccines have been responsible for dramatic decreases in morbidity and mortality secondary to infectious disease, and in the case of smallpox, has globally eradicated a once life-threatening illness.However, while true adverse consequences of vaccination have never exceeded the level of adverse consequences of infection in the absence of vaccination, the public perception of harm secondary to vaccine administration has threatened to overshadow the victory of disease prevention.With the inception and continued evolution of immunization, the number of individuals protected against diseases has steadily increased. Unfortunately, the number of vaccine-related adverse events has also increased proportionally to vac-... 

Cherry JD, Connor JD, McIntosh K, et al. Clinical and serologic study of four smallpox vaccines comparing variations of dose and routes of administration Standard percutaneous revaccination of children who received primary subcutaneous vaccination. J Infect Dis. 1977 135 176-182. 

Systemic fungal infections hypersensitivity to the drug IM use in ITP administration of live virus vaccines (eg, smallpox) in patients receiving immunosuppressive corticosteroid doses (see Warnings). 

Hospital administrators felt that the risk and costs associated with a preevent vaccination program outweighed the risk of a smallpox attack. Even if an outbreak were to occur, given the effectiveness of the vaccine for 3 days after exposure, hospital administrators felt rapid mass vaccination efforts and quarantine of exposed individuals would probably be effective in connolhng the spread of the disease. 

Physician concerns about the vaccine were similar to those of other health care workers and hospital administrators. A physician survey at Yale University, conducted in the spring of 2003, revealed that fewer than 3% of physicians offered the vaccine choose to receive it. Factors associated with physician refusal included concerns that the vaccine was unnecessary without a detailed description of the risk of a smallpox attack, physicians wanted to wait and see how safe the vaccine was. In addition, some physicians, primarily those who worked in the emergency department, had concerns about compensation for time off and liability for adverse reactions (33). 

VACCINES Active immunization, or vaccination, involves administration of an antigen as a whole, killed organism, attenuated (live) organism, or a specific protein or peptide constituent of an organism. Booster doses often are required, especially when killed (inactivated) organisms are used as the immunogen. In the U.S., vaccination has sharply curtailed or practically eliminated a variety of major infections, including polio, smallpox, diphtheria, measles, mumps, pertussis, rubella, tetanus, Haemophilus influenzae type b, and pneumococcus. 

The CDC estimates that 14 to 52 out of every million people who are vaccinated for smallpox will suffer serious, potentially life-threatening reactions to the vaccine. In these cases, immediate medical attention is required. The first course of treatment is with vaccinia immune globulin (VIG). If a patient does not respond to treatment with VIG, a second option is cidofovir, a drug that currently is approved by the Food and Drug Administration (FDA) to treat specific viral infections of the eye in individuals with compromised immune systems. 

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