Smallpox vaccine live smallpox vaccine (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07BX01 (Smallpox vaccines)

Active Substance

Smallpox vaccine (USP United States Pharmacopoeia)

Dosage Form

Smallpox vaccine

Lyophilisate for preparation of solution for intradermal administration and cutaneous scarification application: amp. 20 doses 5 pcs. in set with solvent

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intradermal administrationand cutaneous scarification application in the form of a porous mass from white-gray to light yellow in color, hygroscopic; solvent – colorless, transparent, syrup-like liquid, odorless.

* Smallpox vaccine is a lyophilisate containing vaccinia virus grown on the scarified skin of calves, partially freed from bacterial flora by treatment with chlorhexidine bigluconate. Smallpox vaccine contains from 1×10⁸ to 2×10⁹ PFU in 1 ml. The vaccine does not contain antibiotics.

Excipients: peptone (stabilizer) – in a final concentration of 5-10%.
Solvent glycerol solution 50% – 0.3 ml (ampoules)**.

20 doses (from a volume of 0.2 ml in an ampoule) – ampoules (5) in a set with solvent (amp. 0.3 ml 5 pcs.) – cardboard packs.

** 1 ml of solvent contains: glycerol – 563 mg, McIlvaine phosphate-citrate buffer solution 0.004M*** – up to 1 ml.
*** Composition of McIlvaine phosphate-citrate buffer solution 0.004M: citric acid monohydrate, disodium hydrogen phosphate anhydrous, or disodium hydrogen phosphate dihydrate, or disodium hydrogen phosphate dodecahydrate, purified water.

Clinical-Pharmacological Group

Vaccine for the prevention of smallpox

Pharmacotherapeutic Group

Vaccines; viral vaccines; other viral vaccines

Pharmacological Action

The vaccine induces specific immunity against smallpox for a duration of at least 5 years.

Indications

• Prevention of smallpox for epidemic indications;
• Vaccination (revaccination) of persons working with vaccinia virus and animal pox viruses pathogenic to humans.

ICD codes

Dosage Regimen

The vaccine is applied cutaneously by the scarification method or by the multiple puncture method.

The vaccination site is the outer surface of the shoulder 8-10 cm below the shoulder joint, free from vaccination scars. The skin at the vaccination site is wiped with ether or acetone, or 70% ethyl alcohol solution, and after drying, the vaccination is performed.

Before dissolving the vaccine, the end of the ampoule with the vaccine and both ends of the ampoule with the solvent are wiped with a swab moistened with ether or 70% ethyl alcohol solution, after drying, they are nicked with an ampoule scarifier and the end of the ampoule with the vaccine and one end of the ampoule with the solvent are broken off using the same swab. The open end of the ampoule with the solvent is inserted into the open ampoule with the vaccine from above, and then the second end of the ampoule with the solvent is broken off. The solvent flows into the ampoule with the vaccine. The solvent is mixed with the vaccine using a sterile glass rod (the dissolved vaccine is an opalescent liquid from whitish-gray to light yellow in color without sediment and foreign inclusions). The ampoule with the dissolved vaccine is covered with a sterile napkin or cotton wool. Scarification method: during vaccination, one drop of vaccine (•) is applied with a glass rod, during revaccination – 3 drops at a distance of at least 2 cm from each other (_•^•_•). At the site of vaccine application, a single non-bleeding incision 0.5 cm long is made with a sterile smallpox vaccination pen and the vaccine is lightly rubbed into the incision site with the flat side of the same smallpox vaccination pen.

Multiple puncture method: an individual bifurcated (two-pronged) needle is used for vaccination. The end of the sterile needle is immersed into the ampoule with the diluted vaccine and then with the same needle, perpendicular to the skin, 5 punctures are made for vaccination – 5 punctures, for revaccination – 15 punctures at a distance of 1 mm from each other. Small droplets of lymph or blood should appear at the vaccination site. The vaccination site is left open for 5-10 minutes. Applying a bandage to the vaccination site is not allowed.

Assessment of vaccination results

The skin reaction during vaccination, as well as revaccination after a long period (20-25 years or more), is characterized by the formation of vaccinial elements at the vaccination site. On the 3rd-4th day after vaccination, redness, swelling, and a nodule-papule appear, which increases, and a narrow zone of redness appears around it. On the 6th day, the papule transforms into a vesicle – a blister with transparent contents. By the 7th-8th day, a wider rim of redness – an areola – forms around the vesicle. From the 8th day, the vesicle turns into a pustule. It reaches its maximum size by the 8th-10th day, after which the reaction subsides, a crust forms and after it falls off – a scar forms (usually on the 3rd week).

The described clinical picture is called a primary-type reaction and is noted in non-immune individuals. During revaccination, in addition to this reaction, so-called accelerated and immediate reactions occur. In an accelerated reaction, all stages of development of vaccinial elements proceed in an accelerated manner with maximum severity on the 4th-5th day. In an immediate reaction, erythema, induration and sometimes a papule appear within 24-48 hours. In some cases, a transition of the papule to a vesicle is observed. This type of reaction to vaccination is usually noted in individuals with a high level of immunity to smallpox. Very rarely, a negative skin reaction is observed – the absence of vaccinial elements at the vaccination site. In such cases, the humoral response must be investigated by determining the content of virus-neutralizing antibodies in the serum of the vaccinated person.

The results of vaccination are assessed on the 8th day after vaccination, the results of revaccination – on the 2nd-4th day. Vaccination is considered successful with the development of a pustule, revaccination – with the development of a pustule, vesicle or erythema and induration. The results of vaccination (revaccination) are noted in the appropriate accounting forms.

Adverse Reactions

In response to the administration of the vaccine, the development of local and general adverse reactions is possible.

Local reactions pain at the injection site, local lymphadenitis.

General (systemic) reactions malaise, headache, fever up to 39°C (102.2°F).

In rare cases, severe reactions and complications are observed.

Severe reactions include: fever above 39°C (102.2°F), redness and swelling extending beyond the shoulder; necrosis at the vaccination site within the first 3 days; additional pustules with a temperature above 38°C (100.4°F).

Complications include: autoinoculation: generalized, gangrenous (progressive) vaccinia; vaccinal eczema; encephalitic reaction (synonyms: encephalopathy, neurotoxic syndrome, convulsive syndrome, febrile seizures); postvaccinal encephalitis (meningoencephalitis, encephalomyelitis); polyradiculoneuritis; serous meningitis.

By frequency, reactions occur

Very often (≥1/10) – pain at the injection site, local lymphadenitis, fever up to 38.5°C (101.3°F).

Often (1/10 -1/100) – fever above 38.5°C (101.3°F).

Contraindications

The list of diseases that are a contraindication to vaccination for epidemic indications is determined by the Ministry of Health of Russia.

When vaccinating persons working with the vaccine virus and animal pox viruses pathogenic to humans, it is necessary to adhere to the following list of medical contraindications

Use in Pregnancy and Lactation

Administration of the vaccine is contraindicated during pregnancy and breastfeeding.

Special Precautions

Persons subject to vaccination must be preliminarily examined by a doctor with mandatory thermometry!

To prevent the transfer of the vaccine virus, persons suffering from skin diseases should not contact the vaccinated person until the crusts fall off or for 28 days after vaccination.

It is not recommended to carry out vaccinations during the hot months.

Only medical personnel who have undergone special training are authorized to perform vaccination.

It is necessary to carefully protect the vaccine administration site from damage; wetting it is strictly prohibited.

After vaccination, medical observation is carried out for the vaccinated person to assess the results of the vaccination and timely identification of unusual reactions and post-vaccination complications.

The instruments used for vaccination must be sterile and for single use. Opening of ampoules and vaccination are carried out in strict compliance with the rules of asepsis and antisepsis.

The drug in ampoules with damaged integrity, labeling, changed physical properties, or expired shelf life is not suitable for use. The vaccine is used only during one working day, but no later than 6 hours after its dilution.

The residue of the vaccine solution, materials, and instruments used when working with the smallpox vaccine are disinfected by boiling for 30 minutes or by immersion in a 3% chloramine solution or 3% hydrogen peroxide solution, then autoclaved for 45 minutes at a temperature of 132°C (269.6°F), steam pressure 0.20 MPa.

Effect on ability to drive vehicles, mechanisms

No information available.

Overdose

Cases of overdose have not been described.

Drug Interactions

Vaccinations against other diseases can be carried out no earlier than 30 days after vaccination/revaccination against smallpox.

Storage Conditions

In accordance with SP 3.3.2.1248-03 at a temperature from 2 to 8°C (46.4°F). Keep out of reach of children. Freezing is not allowed.

Shelf Life

Shelf life – vaccine – 2 years; solvent – 3 years.

Dispensing Status

For medical and preventive institutions.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.