Smallpox vaccine

SMALLPOX VACCINE (LIVE)

The product contains lyophilized, live virus (Vaccinia variolae) cultured on the skin of calves. Live culture was partially cleared from bacteria with phenol or chlorhexidine treatment, followed by centrifugation in the presence of freon 113. Peptone is used as a stabilizer. Vaccine appears like a porous white, light-gray or light yellow substance. The solvent to prepare the vaccine for immunization is supplied.

Biological and Immunological Properties: Smallpox vaccine induces establishing of specific immunity to the smallpox. The status may last for at least 5 years after immunization.

Directions: The product is used for prophylactic immunization against smallpox, upon epidemical indications, for vaccinating the persons working with vaccine virus or animal smallpox viruses, which are pathogenic to the humans.

Dosage and administering: Vaccination has to be carried out aseptically in proper environment. Freshly prepared solution of the vaccine is administered epicutaneously using scarification (scratching) method or the multi-puncturing method (on the area of 5 mm in diameter). In further, the place of vaccine application must be kept free; any local contacts with water must be avoided. Not used vaccine has to be destroyed with boiling for 15 min or sinking in 5%-chloramine solution. Given the list of possible restrictions and complications – ii is highly desirable to have a medical exam to verify the patient’s health condition and applicability of the vaccinating.

Side effects and reactions: The results of vaccination are examined on the 8th day after vaccination or on the 2nd day after revaccination. Vaccination is considered as a success if the pustule has been developed; revaccination is successful if resulted in papule, vesicle, erythema or indurations developing. The results of vaccination are registered in standard Case Report Form. Vaccinating may cause general malaise, headache, fever, and local lymphadenitis. More rarely the severe reactions or complications might be observed: fever up to 39єC, hyperemia and edema outside the shoulder, necrosis at the site of inoculated vaccine (for the first 3 days), additional pustules at temperature 38єC. Among complications are generalized gangrenous (progressive) vaccine, eczema, postvaccinal encephalitis (meningoencephalitis, encephalomyelitis), polyradiculoneuritis, serous meningitis, encephalic reaction (synonyms: encephalopathy, neurotoxic syndrome, convulsive disorder, febrile convulsions), exacerbation of somatic diseases. In order to prevent transmission of the vaccine virus to the persons with skin diseases (eczema, exudative diathesis) these persons should not come in contact with vaccinated persons before the crust shedding. Vaccination against other diseases is allowed in 15 days after the smallpox vaccination. Vaccination during the hot months should be avoided.

Contraindications: Vaccinating is restricted to the patients with decompensated cardiovascular abnormalities, pregnant, oncological patients or patients with hormonal disorders. For the patients infected with hepatitis-B, tuberculosis or ones having asthma or history of being highly allergic – the vaccinating would be possible in 2-6 months after the active stage of disease is over. For the pneumonia, the period before the vaccinating becomes allowable – 12 months after remission. For any neurological diseases – the vaccinating is allowed in 24 months after the active phase of disease is ended.

Package: Vaccine is supplied in ampoules. One ampoule contains 0.1 ml or 0.2 ml of the vaccine (10 and 20 doses for scarification; 50 and 100 doses for puncturing, correspondingly). Solvent (50% glycerin solution is distributed in double-neck capillary ampoules. The freshly prepared solution of the vaccine should be colorless, clear, without inclusions or precipitates.

Storage and transportation: The vaccine should be stored at temperature above 10°C, in locked store room, protected from moisture, sun light and rodents. Shelf life of the vaccine is for 2 years. Under indicated conditions the vaccine may be shipped by any kind of transportation.