Scientific electronic library. What is the STI vaccine? Anthrax live vaccine

If the anthrax vaccine is not supplied, a person becomes infected by eating the meat of an affected animal, so it. Anthrax is a particularly dangerous pathology of infectious origin. If a person becomes infected, there is an incubation period, then carbuncles form on the surface of the dermis. The disease is spread by contact. To avoid infection, meat products should be purchased from quality suppliers.

The first symptoms may appear after 4 days. To make a diagnosis, you need to examine sputum, exudate separated from the surface of the skin, then the doctor prescribes other examinations. For treatment, drugs of the penicillin series are used. Anthrax is caused by the rod-shaped bacterium Bacillus anthracis.

Clinical manifestations

The incubation period lasts 4 days (sometimes up to 2 hours). Among people, the carbuncle form of the disease is common. In this case, a pea-sized formation forms on the skin. At first, it looks like a reddish spot, then it turns into a papule that rises above the surface of the skin. The symptom of anthrax is itchy skin.

With the progression of the pathology, the papule is filled with serous contents and slightly increases. In the future, it acquires a dark color. After a few days, a black scab forms on the surface, the formation becomes like a crust, redness and swelling are localized around it. If the formation is located on the cheeks or neck, it can lead to damage to the respiratory system, followed by suffocation. Pathology is accompanied by intoxication, a person develops malaise, a feeling of aching muscles.

Pathology proceeds against the background of fever. A few days after infection, a decrease in temperature is observed, the symptoms subside. After 15 days, the formations disappear, a scar remains on the skin. In exceptional cases, several carbuncles are formed. The danger is those that have formed on the head, in this case, there is a high probability of suffocation and sepsis. Timely access to a doctor significantly improves the prognosis of life.

Some are diagnosed with the ideomotor form of the disease. Pathology is accompanied by tissue hyperemia, the formation of carbuncles. The generalized form of the pathology leads to damage to the respiratory system. Symptoms can be confused with SARS. With a generalized form, intoxication, runny nose, cough occur. A characteristic symptom is tachycardia. After 2 hours, the temperature rises to critical levels, the patient feels unbearable pain in the sternum. Wet cough contains blood clots. In the future, the activity of the heart is disturbed.

The intestinal form of anthrax is extremely dangerous, pathology leads to death. First there is a fever, then - intoxication. A person feels severe pain in the throat, their duration is up to 2 days. The disease leads to nausea. A symptom of the intestinal type of the disease is vomiting with blood clots, the patient also has diarrhea. The progression of pathology leads to disorders in the cardiovascular system. The face acquires a bluish color, a hemorrhagic rash appears on the surface of the skin. The septic form of anthrax lead to death.

Pathology can occur against the background of the disease "Meningitis". The progression of anthrax leads to meningoencephalitis, swelling of the cerebral cortex. Other dangerous complications:

• pulmonary edema;
• asphyxia;
• bleeding in the digestive tract.
• anthrax can lead to sepsis and shock.

Diagnostic measures

To confirm anthrax, diagnostics is carried out in several stages. Biological materials are examined, bakposev is performed, serological tests are carried out. An x-ray of the lungs is required to confirm the diagnosis. The picture may show clinical signs of pneumonia or Pleurisy disease. If necessary, the patient consults a pulmonologist, the doctor may prescribe a pleural puncture. At the initial stages, an examination by a dermatologist is required.

The doctor prescribes penicillin drugs, they, as well as other serums, are administered intravenously. Duration of application - 7 days. Drugs help eliminate the symptoms of intoxication. The anthrax vaccine for humans is Doxycycline. To suppress the pathogen, injections of ciprofloxacin are used. Further therapy is carried out to prevent intoxication. Preparations containing Prednisolone are introduced. If the pathology leads to a dangerous complication, intensive treatment is prescribed. To eliminate skin manifestations, special dressings are applied. Anthrax is not treated with surgery.

The disease has a different prognosis. If the cutaneous form of the disease has been diagnosed, the prognosis is good. Generalized species are not fatal. With timely treatment, it will be possible to improve the prognosis. It is important to observe sanitary and hygienic standards, they will ensure the prevention of anthrax. It is necessary to process animal raw materials in a timely manner and store them properly. It is important to follow the rules for transporting and burying affected livestock.

It is required to adhere to sanitary and hygienic rules when working with livestock. If there is a risk of infection, you need to get an anthrax vaccine, so you can protect yourself from the disease. Vaccination is carried out in clinics, after the procedure it is necessary to follow the recommendations of the doctor.

Experiences and how the anthrax vaccine spreads

Who created the anthrax vaccine? The scientist's name is Louis Pasteur. The disease-causing bacterium was discovered in the late 19th century by Robert Koch. Louis Pasteur founded an experiment that demonstrated the effect of a vaccine. The researchers took 50 sheep and divided them into two groups. One group was vaccinated, the other was not. A month later, the sheep were given a vaccine containing live cultures. Sheep that received the anthrax vaccine survived, while others died.

In 1954, experts developed a vaccine for humans. It became available in the early seventies. Today, the vaccine is produced in dry form and is used for subcutaneous administration. The certified preparation contains active substances with glycerin. If a person is at risk of becoming infected, it is necessary to get vaccinated.

Vaccination is needed for laboratory assistants who are in contact with sick people, veterinarians, and people working in enterprises. Vaccination should be carried out by persons working in slaughterhouses. In the early nineties, 25 million people were vaccinated. The researchers are confident that if the drug is in every medical institution, the risk of the spread of pathology will decrease.

The vaccine is intended for animals older than three months. The drug is produced in specialized vials and stored under optimal conditions. The anthrax vaccine is a transparent white, homogeneous liquid.

Shelf life of the drug, storage conditions

Instructions for use contain information that the drug has spores of anthrax capsuleless virulent culture. The active ingredients are mixed with a solution of glycerin. The vaccine is available in different bottles, depending on the body weight of the animal, the veterinarian chooses a volume of 20, 50 or 100 ml. One milliliter of the active ingredient contains 20 million spores. Anthrax live dry vaccine is administered by an experienced veterinarian. Independent use is prohibited! The bottle contains information about the manufacturer, the data of the packer, as well as the time of creation. The instruction contains dosages and storage conditions.

According to the established rules, the drug is supplied to pharmacies in wooden boxes (capacity 1 - 15 kg). In these boxes there is a control document with full information about the drug. If transportation is planned, it is necessary to create optimal conditions. The anthrax vaccine is transported at a temperature of + 15 degrees. The drug is not stored in conditions where the air temperature is below 0. The vaccine is stored for 2 years. If deviations from generally accepted standards are detected, the drugs are destroyed. If necessary, batches or individual medicinal formulations are rejected.

Animal vaccine use

The drug is used for prevention purposes. The dosage is different. Intramuscular administration of the active substance requires compliance with the rules. If they are violated, side effects will occur that will lead to the death of the animal. The drug is administered if the animal is already 3 months old, respectively, the contraindication is children's age. The vaccine can be used to vaccinate goats, sheep. The doctor inserts it into the neck or chest area. Dosages are strictly individual. If the drug is used for cattle vaccination, the dose is increased. The injection area is behind the ear or near the thigh.

Before you enter the drug, you should disinfect the skin. For these purposes, alcohol or a weak solution of phenol is used. The vaccine is administered with a high-quality syringe, you need to choose one on which the needles will hold well. The needles should not be short, a suitable length is 15 mm. Before the introduction of the composition, the instruments should be disinfected by treating them in boiled water. Sterilization is necessary to prevent infection.

After use, the tools are boiled with a weak solution of soda. The duration of boiling is one hour. Before the introduction, it is necessary to shake the medicinal composition, a liquid of uniform color should be obtained. If the vial has been opened, but the veterinarian has not used the composition, it must be discarded. Anthrax liquid vaccine is used by a veterinarian, the animal is examined beforehand.

If signs of any disease are detected, vaccination is postponed and done after the animal recovers. The introduction is contraindicated at elevated temperature, weakness, general malaise. The drug can be used to vaccinate pregnant females, but only if absolutely necessary. If you follow the rules for using the medicine, there will be no side effects.

Veterinarians do not advise vaccinations in summer and in cold weather. The weather should be moderately warm. After vaccination, it is necessary to carefully monitor the animal, it should not be subjected to stress, hypothermia. It is necessary to provide a good rest. If the vaccine is given to horses, they are suspended from work for a week. It is important to observe the timing of vaccination, the drug is administered once every 12 months.

The doctor may prescribe an emergency vaccination. In such a case, the drug can be administered if the condition of the animal is satisfactory.

If it is necessary to vaccinate lambs and kids that are 3 months old, re-vaccination is carried out after reaching one year. The vaccine is used to prevent the disease in calves that have reached the age of three months, after six months, adult immunization is required. Immunization of foals for the first time is carried out at the age of 9 months, then - upon reaching maturity.

The drug is administered to horses once, at a time when the body is completely healthy. When the camel is three months old, immunization is required, then once a year.

Forced vaccinations are carried out regardless of the season. There are times when you need to immunize an animal with an infectious pathology. However, if a particular disease is very acute and there is a significant increase in temperature, the timing of vaccination is reviewed. In some cases, the drug is administered after the treatment of the disease. The vaccine from strain 55 is not compatible with others, as well as with drugs that have a similar mechanism of action.

For ten days after the introduction, the skin of the animal cannot be disinfected. Serums for the treatment of diseases are not administered intravenously. The health of the animal is controlled by a veterinarian. After twelve days, resistance to anthrax bacteria is formed. The maximum duration of immunity is 11 months. Some animals are hypersensitive to the vaccine. Swelling appears in the injection area, the temperature may rise, and chills may occur. Swelling disappears after two days, fever is rare. Side effects are possible if the rules for administering the composition have been violated.

A person becomes infected through contact with a sick animal, contaminated animal products or the remains of dead animals. In Russia, about 8,000 anthrax animal burial grounds have been recorded, mainly in the Volga, Central and Southern federal districts. The spores are highly resistant and can spread over long distances.

Anthrax occurs in skin, intestinal and most severe pulmonary forms, the latter develops with inhalation infection. The incubation period is from several hours to 12 days. Mortality in untreated skin form - 5-20%, with intestinal - 25-75%, pulmonary - even higher. Unlike animals, a sick person does not excrete the pathogen and is therefore not contagious to others, which limits the use of anthrax for bioterrorism purposes.

In Russia, single cases of anthrax are observed annually (3 in 2007). In the US, the pathogen and its spores have been used for bioterrorism purposes. In Russia, they are vaccinated in enzootic regions. 2 vaccines are registered:

Live dry anthrax vaccine for subcutaneous and scarification application - live spores of the STI vaccine strain, lyophilized in 10% aqueous sucrose solution. Release form: 1.0 ml of vaccine in an ampoule (200 or 100 doses for subcutaneous or 20 or 10 doses for skin vaccination, respectively) + 1.5 ml of solvent for cutaneous application - 30% glycerol solution. The anthrax vaccine is stored and transported at a temperature of 2-10° (at 25° - no more than 20 days).

Anthrax vaccine combined lyophilizate for subcutaneous administration is a mixture of live spores of the STI-1 vaccine strain and purified. concentrated protective anthrax antigen (PA) adsorbed on an aluminum hydroxide gel. The drug is lyophilized in ampoules from the initial volume of 3 ml (10 doses). When adding 0.9% sodium chloride solution, a homogeneous suspension is formed. Release form: dry preparation (10 doses) in ampoules, solvent - saline solution in 6 ml ampoules. Liquid preparation of 5 ml (10 doses) - in ampoules or vials. In a pack of 5 ampoules (vials) of liquid vaccine or 5 ampoules of dry vaccine and solvent. The vaccine is stored at a temperature of 2-6 °, transport. yut at 2-10°. Shelf life of dry vaccine - 3 years, liquid - 2 years.

Immunological properties of the anthrax vaccine

Both vaccines are used in adolescents from 14 years of age and adults, they cause the formation of intense immunity lasting up to 1 year.

Contraindications for anthrax vaccination

In addition to the general contraindications for live vaccines, the following are considered:

• systemic connective tissue diseases;
• common recurrent skin diseases;

The interval between anthrax vaccination and other anthrax vaccines must be at least one month.

Reactions to anthrax vaccine

When applied to the skin, a local reaction appears after 24-48 hours in the form of hyperemia, a small infiltrate, followed by the formation of a crust. With subcutaneous administration of both vaccines, after 24-48 hours, there may be slight hyperemia at the injection site, less often - an infiltrate of up to 50 mm. A general reaction to the anthrax vaccine rarely occurs: on the 1st day, malaise, headache, temperature up to 38.5 ° and swollen lymph nodes.

Methods of application and dosage of the anthrax vaccine

Scheduled vaccination is carried out by skin method in the first quarter of the year, i.e. before the most dangerous spring-summer season. Primary vaccination is carried out with both vaccines, revaccination - once a year subcutaneously with a vaccine for subcutaneous and scarification use. The first three revaccinations are carried out by introducing in a volume of 0.5 ml (50±10 million spores), and all subsequent - every two years in a volume of 0.5 ml (5±1 million spores). Unscheduled is better to instill subcutaneously.

Vaccine against anthrax live dry for subcutaneous and scarification application is used in 2 ways. Primary immunization (from the age of 14 years) - twice with an interval of 20-30 days. For all vaccinations, the skin dose is 0.05 ml and contains 500 million spores, one subcutaneous dose of 0.5 ml contains 50 million spores.

Vaccination by the skin (scarification) method is carried out on the outer surface of the middle third of the shoulder through 2 drops of the diluted vaccine at a distance of 3-4 cm, making 2 parallel incisions 10 mm long, followed by rubbing for 30 seconds. The contents of the ampoule are resuspended in a solvent immediately before use: 0.5 ml per ampoule with 10 skin doses, 1.0 ml with 20 doses. RaZh administered vaccine, stored aseptically, is used within 4 hours.

Vaccination against anthrax by subcutaneous method: the drug is resuspended in 1.0 ml of sterile 0.9% sodium chloride solution, then transferred into a sterile vial with 99 ml of the same solution for a 200 subcutaneous dose ampoule or 49 ml for a 100 dose ampoule. The vaccine is injected subcutaneously into the region of the lower angle of the scapula in a volume of 0.5 ml.

Vaccinations with anthrax vaccine combined dry and liquid for subcutaneous use are carried out once. In an ampoule (bottle) with 10 doses, 5.0 ml of sterile saline is injected, one dose (0.5 ml) contains 50±10 million spores AND 0.35±0.05 mg of PA protein. From the opened ampoule, stored aseptically, the vaccine is used for 4 hours. The anthrax vaccine is injected into the region of the lower angle of the left shoulder blade.

Post-exposure prophylaxis of anthrax

The causative agent of anthrax is resistant to co-trimoxazole and many cephalosporins, in case of alleged contact with it, adults are recommended ciprofloxacin or doxycycline, children - amoxicillin 80 mg / kg / day (up to 1.5 g / day).

Anthrax refers to an infectious disease, accompanied by a severe course. It develops mainly in the form of a skin form. To prevent its spread, it is necessary to treat anthrax to a certain group of people.

Indications for anthrax vaccination in humans

This vaccination is administered in two cases: planned and according to epidemic indications.

The planned introduction of the vaccine is carried out:

• persons involved in the slaughter of livestock, as well as the transportation, collection, storage and sale of animal meat;
• people working in a laboratory with live cultures of anthrax bacilli, including those engaged in research on infected animals and materials;
• veterinarians;
• persons whose labor activity is connected with the processing of leather and wool.

Vaccination usually takes place in the first quarter of each year.

Composition and principle of action of live dry STI anthrax vaccine

The composition of the vaccine includes:

• lyophilized suspension of live spores of bacillus anthracis strain STI-1;
• purified anthrax antigen;
• aluminum hydroxide gel;
• stabilizer, represented by an aqueous solution of sucrose 10%.

The ampoules contain a porous gray-white mass with a brown tint. The anthrax vaccine is presented as a vacuum-dried suspension of spores of the STI-1 strain (STI - Sanitary and Technical Institute, where the vaccine was developed).

For its manufacture, a resistant type of anthrax bacilli is used, which cannot cause disease in humans. The vaccination is done twice with an interval of 20 to 30 days, while forming a stable specific immunity, which is formed on the seventh day after vaccination and is valid for one year.

Instructions for use of the anthrax vaccine for humans

Each ampoule must be checked for damage before use.

The introduction of the vaccine is carried out in two ways: cutaneous and subcutaneous:

Contraindications to the introduction of prophylactic vaccinations

There is a spectrum of contraindications that limits the use of the vaccine:

• acute form of infectious and non-infectious diseases. In this case, the vaccination is allowed to be administered only one month after complete recovery;
• recurrent skin diseases;
• pathology of the endocrine system;
• a history of both primary and secondary immunodeficiencies;
• pregnancy and breastfeeding.

Before vaccination, it is necessary to visit a doctor who will examine the patient to exclude contraindications, as well as thermometry.

Side effects and complications

In the first days after the introduction of the vaccine, lethargy, headaches, including an increase in body temperature to 38.5 °, may appear. A slight enlargement of the lymph nodes may also be present.

In a rare case, it can cause local manifestations that depend on the individual characteristics of the organism:

• after 1-2 days, redness or infiltration may appear. Also, yellow crusts appear in the area of ​​the notches;
• within the same period, pain may occur.

These reactions are short-lived and resolve on their own without additional treatment.

In the event of a reaction of the body to the vaccine, it is necessary to consult a doctor to clarify the condition.

Price and where to make

Scheduled vaccine administration should be free. Vaccination is administered only in medical institutions.

Vaccine anthrax live dry

If vaccination concerns animals, then the vaccination can be done both in a veterinary clinic and by calling a veterinarian at home. Especially when it comes to cattle. The price of the drug depends on the dosage. On average, in Russia, the cost of a drug for 100 doses starts from 1000 rubles and more.

Anthrax vaccine

Instructions for use of live dry anthrax vaccine for subcutaneous and scarification use

The vaccine is live spores of the vaccine anthrax strain STI, lyophilized in a 10% aqueous solution of sucrose, has the form of a homogeneous porous mass of grayish-white or yellowish-white color.

Immunological properties

Anthrax live dry vaccine after double application with an interval of 20 ... 30 days causes the formation of intense immunity lasting up to 1 year.

Purpose

Specific prevention of anthrax from the age of 14.

Vaccinations are subject to:
• persons working with live cultures of the anthrax agent, with infected laboratory animals or conducting research on materials contaminated with the anthrax agent;
• persons engaged in slaughtering, harvesting, collecting, storing, transporting, processing and selling raw materials of animal origin;
• persons performing the following work in anthrax enzootic territories:
  - maintenance of public livestock;
  - agricultural, agro- and hydro-reclamation, construction and other works related to the excavation and movement of soil;
  - procurement, commercial, geological, prospecting, forwarding.

In a planned manner, vaccination is carried out by the skin method in the first quarter of the year, since the most dangerous in relation to infection with anthrax in disadvantaged areas is the spring-summer season.

Method of application and dosage

The vaccine is used by skin (scarification) and subcutaneous methods. It is expedient to carry out unscheduled vaccination by the subcutaneous method.

Primary immunization is carried out twice with an interval of 20 ... 30 days, revaccination is carried out once annually. For all vaccinations, the skin dose of the vaccine is 0.05 ml and contains 500 million spores, one subcutaneous dose of 0.5 ml contains 50 million spores.

Each vial of vaccine is carefully inspected before use. The vaccine should not be used: if the integrity of the ampoule is damaged, if the appearance of the dry and dissolved preparation changes (foreign particles, unbroken lumps and flakes), if there is no label, after the expiration date, if the storage regime has been violated.

Vaccination by skin (scarification) method

Immediately before use, the contents of the ampoule are resuspended in a sterile 30% aqueous solution of glycerol, which is introduced into the ampoule using a syringe with a needle for intramuscular injection. The volume of the solvent is determined by the number of vaccination doses in the ampoule. In an ampoule with 10 skin doses, 0.5 ml is added, and with 20 skin doses, 1.0 ml of the solvent. The ampoule is shaken until a homogeneous suspension is formed. The dissolution time of the vaccine should not exceed 5 minutes. The diluted vaccine from an opened ampoule, stored under aseptic conditions, can be used for 4 hours. The vaccination is carried out on the outer surface of the middle third of the shoulder. The vaccination site is treated with alcohol or a mixture of alcohol and ether. The use of other disinfectant solutions is not allowed. After evaporation of alcohol and ether with a sterile tuberculin syringe with a thin and short needle (No. 0415), without touching the skin, one drop (0.025 ml) of the diluted vaccine is applied to 2 places of future incisions at a distance of 3 ... 4 cm. Skin slightly stretch and with a sterile smallpox grafting pen, through each drop of the vaccine, 2 parallel notches 10 mm long are made so that they do not bleed (blood should appear only in the form of small dewdrops). With the flat side of the smallpox grafting pen, the vaccine is rubbed into the notches for 30 seconds and allowed to dry for 5-10 minutes. For each grafted use a separate disposable pen. It is forbidden to use needles, scalpels, etc. instead of feathers.

Vaccination by subcutaneous method

The drug is resuspended in 1.0 ml of sterile 0.9% sodium chloride solution immediately before use. The ampoule is shaken until a uniform suspension is formed. The contents of the ampoule are transferred with a sterile syringe into a sterile vial with 0.9% sodium chloride solution for injection. In the case of using an ampoule containing 200 subcutaneous inoculation doses, the suspension is transferred into a vial with 99 ml, and containing 100 subcutaneous inoculation doses - into a vial with 49 ml of solvent.

In the syringe method, the vaccine is injected into the region of the lower angle of the scapula. The skin at the injection site is treated with alcohol or a mixture of alcohol and ether. The vaccine in a volume of 0.5 ml is administered subcutaneously. A disposable syringe and needle is used for each vaccinated person. Shake the vial before each selection of the vaccine. The injection site is lubricated with 5% tincture of iodine.

When using the vaccine by the subcutaneous needle-free method, the spore suspension is injected in a volume of 0.5 ml into the area of ​​the outer surface of the upper third of the arm with a needle-free injector with a protector, strictly following the instructions for their use. The injection site is treated before and after the injection, as with the syringe method.

Unused vaccine, used grafting disposable syringes and pens are subject to mandatory inactivation by autoclaving at a temperature of (132 ± 2)°C and a pressure of 2.0 kgf/m 2 for 90 minutes.

The parts of the needleless injector in contact with the vaccine, after pre-treatment, are immersed in a 6% hydrogen peroxide solution with 0.5% Progress or Astra detergent for 1 hour at a temperature not lower than 50 °C. The solution is used once.

Parts of the injector are sterilized by autoclaving at a temperature of (132 ± 2) ° C and a pressure of 2.0 kgf / m 2 for 90 minutes.

Reaction to the introduction

When applied to the skin, a local reaction appears after 24...48 hours in the form of hyperemia, a small infiltrate, followed by the formation of a yellowish crust along the incisions. With a syringe and needleless methods of administration, after 24 ... 48 hours at the injection site there may be a slight soreness, hyperemia, less often - an infiltrate with a diameter of up to 50 mm.

A general reaction with cutaneous and subcutaneous administration of the vaccine rarely occurs on the first day after vaccination and is manifested by malaise, headache and a slight increase in temperature. Sometimes there may be an increase in body temperature up to 38.5 ° C and a slight increase in regional lymph nodes.

Contraindications

• Acute infectious and non-infectious diseases - vaccinations are carried out no earlier than 1 month after recovery (remission).
• Primary and secondary immunodeficiencies. When treating with steroids, antimetabolites, X-ray therapy, vaccinations are carried out no earlier than 6 months after the end of therapy.
• Malignant neoplasms and malignant diseases of the blood.
• Systemic connective tissue diseases.
• Common recurrent skin diseases.
• Diseases of the endocrine system.
• Pregnancy and lactation.

In each individual case, for diseases not included in this list, vaccination is carried out only with the permission of the relevant specialist doctor.

The interval between anthrax vaccination and other vaccines must be at least one month. In order to identify contraindications, the doctor (paramedic) on the day of vaccination conducts a survey and examination of the vaccinated with mandatory thermometry.

Vaccinations are carried out by paramedical personnel under the guidance of a doctor.

Release form

1.0 ml of vaccine in an ampoule containing 200 human doses for subcutaneous or 20 human doses for skin vaccination with 1.5 ml of solvent for cutaneous application - 30% aqueous solution of glycerin.

1.0 ml of vaccine in an ampoule containing 100 human doses for subcutaneous or 10 human doses for cutaneous vaccination with 1.0 ml of solvent for dermal application - 30% aqueous solution of glycerin.

The package contains 5 ampoules of the vaccine and 5 ampoules of the solvent

Storage and transportation conditions

The vaccine is stored and transported in accordance with SP 3. 3. 2. 028-95 at a temperature of 2 to 10 °C. Transportation can also be carried out at a temperature not exceeding 25 °C for no more than 20 days.

Best before date

Vaccine produced under vacuum - 4 years; produced without vacuum - 3 years.