Who should get the anthrax vaccine. What are the types of anthrax vaccines available. How effective is the anthrax vaccine. What are the potential side effects of anthrax vaccination. How to pay for and where to find anthrax vaccines.

Understanding Anthrax and the Importance of Vaccination

Anthrax is a serious infectious disease caused by bacteria known as Bacillus anthracis. While uncommon in the general population, certain groups face an increased risk of exposure due to their occupations or specific circumstances. Vaccination plays a crucial role in preventing anthrax infection for these high-risk individuals.

Is anthrax a significant threat to public health? While anthrax is not typically a concern for the general public, it can be a severe and potentially fatal disease if contracted. The bacteria can form spores that can survive in the environment for long periods, making it a potential bioterrorism agent. This is why vaccination is essential for those at higher risk of exposure.

Who Should Consider Anthrax Vaccination?

The Centers for Disease Control and Prevention (CDC) recommends anthrax vaccination for specific groups of adults aged 18 to 65 who may be at risk of exposure due to their occupations or other factors. These groups include:

• Certain laboratory workers who handle anthrax
• Some veterinarians and individuals who work with animals or animal products potentially infected with anthrax
• Specific U.S. military personnel

Are there situations where vaccination is recommended after potential exposure? Yes, the CDC advises anthrax vaccination for individuals who have been exposed to anthrax in certain scenarios, such as following a bioterrorism attack involving the bacteria. In some cases, pregnant women who have been exposed to anthrax may also be recommended for vaccination, although this is not typically advised when the risk of exposure is low.

Contraindications and Precautions for Anthrax Vaccination

While the anthrax vaccine can be life-saving for those at risk, certain individuals should avoid or delay vaccination. It’s crucial to consult with a healthcare professional before receiving the vaccine, especially if you fall into any of the following categories:

• Individuals who have experienced a life-threatening allergic reaction to a previous dose of the anthrax vaccine
• Those with severe allergies to any vaccine components, including latex
• People with weakened immune systems due to medication or illness
• Individuals who have previously been diagnosed with anthrax disease
• Those who are moderately or severely ill at the time of scheduled vaccination

Can individuals with mild illnesses receive the anthrax vaccine? Generally, people with mild illnesses, such as a common cold, can still receive the vaccine. However, it’s always best to consult with a healthcare provider to determine the most appropriate course of action based on individual circumstances.

Types of Anthrax Vaccines Available

In the United States, there is currently only one anthrax vaccine licensed for use by the Food and Drug Administration (FDA):

BioThrax®

BioThrax® is the primary anthrax vaccine available in the U.S. It is administered to individuals aged 18 to 65 who are at increased risk of anthrax exposure. The standard vaccination schedule includes:

• A primary series of five doses over 18 months
• Annual booster doses for those who continue to be at increased risk of exposure

In post-exposure scenarios, BioThrax® is given in combination with antibiotics as a three-dose primary series.

How does the vaccination schedule differ for pre-exposure and post-exposure scenarios? The pre-exposure vaccination schedule consists of five doses over 18 months, followed by annual boosters. In contrast, the post-exposure regimen involves a shortened three-dose series combined with antibiotic treatment to provide rapid protection against potential infection.

Efficacy of the Anthrax Vaccine

The anthrax vaccine has demonstrated high efficacy in protecting individuals from infection, particularly when administered before exposure to the bacteria. Studies have shown that the vaccine is effective in protecting approximately 90% of vaccinated individuals from anthrax infection.

How long does protection from the anthrax vaccine last? While the initial vaccination series provides strong protection, the duration of immunity is not fully known. This uncertainty is why individuals who continue to be at high risk of exposure are recommended to receive annual booster doses to maintain optimal protection.

Factors Influencing Vaccine Efficacy

Several factors can impact the effectiveness of the anthrax vaccine:

• Adherence to the recommended vaccination schedule
• Individual immune response
• Time elapsed since the last dose
• Potential exposure to different strains of anthrax bacteria

Does the anthrax vaccine provide complete protection against all forms of anthrax? While the vaccine is highly effective, it cannot guarantee 100% protection against all cases of anthrax. However, it significantly reduces the risk of infection and can mitigate the severity of symptoms if infection does occur.

Potential Side Effects of Anthrax Vaccination

As with any medical intervention, the anthrax vaccine can cause side effects. Most individuals who receive the vaccine experience mild reactions that resolve on their own within a few days. However, it’s essential to be aware of potential side effects and monitor for any unusual symptoms following vaccination.

Common Mild Side Effects

The most frequently reported mild side effects of the anthrax vaccine include:

• Reactions at the injection site:
  • Redness
  • Swelling
  • Soreness or tenderness
  • Itching
  • Formation of a lump or bruise
• Muscle aches or temporary limitation of arm movement
• Headache
• Fatigue

Are these side effects a cause for concern? Generally, these mild side effects are not cause for alarm and typically resolve within a few days. However, if symptoms persist or worsen, it’s advisable to consult a healthcare provider.

Rare but Serious Side Effects

While rare, more serious side effects can occur following anthrax vaccination. These may include:

• Severe allergic reactions (anaphylaxis)
• Neurological complications
• Autoimmune disorders

What should individuals do if they experience severe side effects? If you experience symptoms of a severe allergic reaction, such as difficulty breathing, rapid heartbeat, or severe dizziness, seek immediate medical attention.

Post-Vaccination Monitoring

To ensure safety, healthcare providers typically recommend that individuals remain under observation for at least 15 minutes after receiving the anthrax vaccine. This precaution allows for prompt medical intervention in the rare event of a severe allergic reaction.

Why is post-vaccination monitoring important? This brief observation period is crucial for detecting and addressing any immediate adverse reactions, particularly anaphylaxis, which typically occurs within minutes of vaccination.

Accessing Anthrax Vaccination

Given that the anthrax vaccine is not routinely available to the general public, accessing vaccination can be more complex than for common vaccines. The availability of the anthrax vaccine is typically limited to specific high-risk groups and controlled distribution channels.

Where to Find Anthrax Vaccines

Anthrax vaccines are generally available through:

• Military medical facilities for eligible service members
• Specialized occupational health clinics for at-risk laboratory workers
• Certain veterinary or animal handling facilities
• Public health departments in the event of a bioterrorism incident

How can individuals in high-risk occupations access the anthrax vaccine? Those who believe they may be eligible for anthrax vaccination due to occupational exposure should consult with their employer or occupational health provider to determine the appropriate steps for accessing the vaccine.

Emergency Vaccination Programs

In the event of a large-scale anthrax exposure or bioterrorism incident, public health authorities may implement emergency vaccination programs. These programs would prioritize individuals with known or suspected exposure to anthrax.

What is the protocol for emergency anthrax vaccination? Emergency vaccination protocols typically involve a combination of antibiotic treatment and a shortened anthrax vaccine series to provide rapid protection against potential infection.

Financial Considerations for Anthrax Vaccination

The cost of anthrax vaccination can vary depending on the circumstances and the individual’s situation. Understanding the potential financial implications and available support options is important for those considering or requiring vaccination.

Occupational Coverage

For individuals who require anthrax vaccination due to occupational exposure:

• Military personnel typically receive the vaccine at no cost as part of their service
• Employers may cover the cost of vaccination for at-risk employees in certain industries
• Some occupational health insurance plans may include coverage for anthrax vaccination

Are employers required to cover the cost of anthrax vaccination for at-risk employees? While not universally mandated, many employers in high-risk industries choose to cover the cost of anthrax vaccination as part of their occupational health and safety programs.

Insurance Coverage

Coverage for anthrax vaccination under private health insurance plans can vary:

• Some plans may cover the vaccine for individuals in high-risk occupations
• Coverage may be subject to deductibles, copayments, or pre-authorization requirements
• Individuals should consult their insurance provider to understand specific coverage details

How can individuals determine if their insurance covers anthrax vaccination? Contact your insurance provider directly to inquire about coverage for the anthrax vaccine, especially if you believe you may be at increased risk due to your occupation or other factors.

Public Health Emergency Situations

In the event of a public health emergency involving anthrax:

• Government agencies may provide vaccination at no cost to affected individuals
• Emergency funding may be allocated to cover vaccination costs
• Public health departments may coordinate vaccination efforts and associated financial support

What financial support is available for anthrax vaccination in emergency situations? During declared public health emergencies, government agencies typically work to ensure that cost is not a barrier to receiving necessary vaccinations, including for anthrax.

Anthrax Vaccination in the Context of Travel and Specific Groups

While anthrax vaccination is not typically recommended for general travel purposes, there are specific scenarios and groups for which it may be considered. Understanding these contexts can help individuals make informed decisions about anthrax vaccination.

Travel-Related Considerations

Anthrax vaccination is generally not recommended for most travelers. However, certain circumstances may warrant consideration:

• Travel to areas with a high incidence of animal anthrax
• Extended stays in regions with limited medical facilities
• Participation in activities that may increase exposure risk, such as veterinary work or archaeological excavations in high-risk areas

Should travelers to high-risk areas routinely receive anthrax vaccination? Routine anthrax vaccination is not recommended for most travelers. However, individuals planning extended stays or engaging in high-risk activities in endemic areas should consult with a travel medicine specialist to assess their individual risk and vaccination needs.

Specific High-Risk Groups

Certain groups may have an elevated risk of anthrax exposure due to their occupations or activities:

• Wildlife biologists working with potentially infected animals
• Anthropologists or archaeologists working in areas with a history of anthrax outbreaks
• Employees in certain mail handling or processing facilities
• First responders who may be involved in bioterrorism response

How do occupational health guidelines address anthrax vaccination for these specific groups? Occupational health guidelines typically recommend a risk assessment for individuals in these groups, with vaccination considered based on the level and likelihood of potential exposure.

Research and Development Personnel

Individuals involved in anthrax-related research and vaccine development may also require vaccination:

• Laboratory workers handling live anthrax bacteria or spores
• Scientists developing new anthrax vaccines or treatments
• Quality control personnel in anthrax vaccine production facilities

What special considerations apply to anthrax vaccination for research personnel? Research institutions and pharmaceutical companies typically have strict protocols for anthrax vaccination of personnel working with the bacteria or its components, often requiring completion of the full vaccination series before beginning work with anthrax.

Future Developments in Anthrax Vaccination

The field of anthrax vaccination continues to evolve, with ongoing research aimed at improving vaccine efficacy, reducing side effects, and developing new administration methods. Staying informed about these developments is crucial for healthcare providers and individuals at risk of anthrax exposure.

Next-Generation Vaccines

Researchers are working on developing new anthrax vaccines with potential advantages:

• Vaccines that require fewer doses for full protection
• Formulations with reduced side effects
• Vaccines that provide broader protection against multiple strains of anthrax
• Combination vaccines that protect against anthrax and other bioterrorism agents

How might next-generation anthrax vaccines improve upon current options? Future vaccines may offer faster immunity, longer-lasting protection, and improved safety profiles, potentially increasing their acceptability and effectiveness in protecting high-risk populations.

Alternative Administration Methods

Research is also focusing on developing new ways to administer anthrax vaccines:

• Intranasal vaccines for easier administration and potentially improved mucosal immunity
• Transdermal patch delivery systems for painless application
• Oral formulations that could simplify large-scale vaccination efforts

What advantages could alternative administration methods offer? These new approaches could potentially increase vaccine acceptance, simplify administration in emergency situations, and improve immune responses, particularly in mucosal tissues that are often the first site of anthrax infection.

Ongoing Clinical Trials

Several clinical trials are underway to evaluate new anthrax vaccines and improved formulations:

• Studies comparing the efficacy of different dosing schedules
• Trials assessing the safety and immunogenicity of novel vaccine candidates
• Research on the long-term protection provided by current and new vaccines

How can individuals stay informed about anthrax vaccine research? Those interested in the latest developments in anthrax vaccination can follow updates from reputable sources such as the CDC, FDA, and major medical journals. Additionally, the ClinicalTrials.gov website provides information on ongoing clinical trials related to anthrax vaccines.

As research progresses, it’s important for healthcare providers and at-risk individuals to stay informed about new developments in anthrax vaccination. These advancements may lead to more effective, safer, and more accessible options for protecting against this potentially deadly disease.

Anthrax Vaccination: What Everyone Should Know

• Who Should Get Anthrax Vaccine?
• Who Should Not Get This Vaccine?
• What Types of This Vaccine Are There?
• How Well Does This Vaccine Work?
• What Are the Possible Side Effects?
• Where Can I Find This Vaccine?
• How Do I Pay for This Vaccine?

Vaccines Recommended for Travel and Some Specific Groups

Key Facts

There is a vaccine to prevent anthrax, but it is not typically available for the general public. Anyone who is at increased risk of being exposed to anthrax, including certain U.S. military personnel, laboratory workers, and some people who handle animals or animal products (such as veterinarians who handle infected animals), may get the vaccine.

Who Should Get Anthrax Vaccine?

There is a vaccine licensed to prevent anthrax, but it is not typically available for the general public. Below is more information about who should and should not get an anthrax vaccine.

Talk to your healthcare professional about what is best for your specific situation.

Learn about the anthrax vaccine at CDC’s What Are the Types of Anthrax Vaccines?.

Before Exposure to Anthrax

CDC recommends anthrax vaccination for three groups of adults 18 through 65 years old who may be at risk of coming in contact with anthrax because of their job:

• Certain laboratory workers who work with anthrax
• Some people who handle animals or animal products, such as veterinarians who handle infected animals
• Certain U.S. military personnel

After Exposure to Anthrax

CDC also recommends vaccination for people who have been exposed to anthrax in certain situations, such as after a bioterrorism attack involving anthrax.

Anthrax vaccination may be recommended for pregnant women who have been exposed to anthrax. However, when risk to anthrax exposure is low, pregnant women are not recommended to get the vaccine.

Who Should Not Get This Vaccine?

Because of age or health conditions, some people should not get certain vaccines or should wait before getting them. Read the guidelines below and ask your healthcare professional for more information.

Tell the person who is giving you an anthrax vaccine if:

You have had a life-threatening allergic reaction or have a severe allergy.

• Anyone who has had a serious allergic reaction to a previous dose of the anthrax vaccine should not get another dose.
• Anyone who has a severe allergy to any vaccine component should not get a dose. Tell your provider if you have any severe allergies, including latex. Your healthcare professional can tell you about the vaccine’s ingredients.

You have been previously diagnosed with specific illnesses or conditions.

• If your immune system is weakened due to medication or illness.
• If you have had anthrax disease in past.

You are not feeling well.

• If you have a mild illness, such as a cold, you can probably get the vaccine. If you are moderately or severely ill, you should probably wait until you recover. Your healthcare professional can advise you.

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What Types of This Vaccine Are There?

There is one anthrax vaccine licensed for use in the United States by the Food and Drug Administration:

• BioThrax®: It is given to people 18 through 65 years old at increased risk of exposure in five doses, with a booster dose each year thereafter for those that continue to be at increased risk of exposure. It is given, in combination with antibiotics, as a three-dose primary series after exposure.

How Well Does the Anthrax Vaccine Work?

Summary

Vaccines that help protect against anthrax work well, but cannot prevent all cases.

• A study showed that the anthrax vaccine protects about 9 people out of every 10 vaccinated prior to exposure to the bacteria.

In Depth

The anthrax vaccine is effective at protecting most people from anthrax, including the most deadly form that can happen when someone breathes the bacterial spores into their lungs. To build up protection against anthrax, people need 5 doses over a period of 18 months. However, it is unknown how long that protection lasts so people who are recommended to get this vaccine are advised to get a booster dose each year to stay protected.

What Are the Possible Side Effects?

Most people who get an anthrax vaccine do not have any serious problems with it. With any medicine, including vaccines, there is a chance of side effects. These are usually mild and go away on their own within a few days, but serious reactions are also possible.

Mild Problems

Mild problems following an anthrax vaccine can include:

• Reactions where the shot was given
  • Redness
  • Swelling
  • Soreness or tenderness
  • A lump or bruise
  • Itching
• Muscle aches or temporary limitation of movement in the arm where the shot was given
• Headache
• Feeling tired

Problems that Could Happen after Any Injected Vaccine

• People sometimes faint after a medical procedure, including vaccination. Sitting or lying down for about 15 minutes can help prevent fainting, and injuries caused by a fall. Tell your healthcare professional if you feel dizzy, have vision changes, or have ringing in the ears.
• Some people get severe arm pain and have difficulty moving the arm where a shot was given. This happens very rarely.
• Any medicine can cause a severe allergic reaction. Such reactions from a vaccine are very rare, estimated at about 1 in a million doses, and would happen within a few minutes to a few hours after the vaccination.
• As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.

For more information on possible side effects from vaccination, visit CDC’s Possible Side effects from Vaccines webpage.

Where Can I Find the Anthrax Vaccine?

Anthrax vaccine is only recommended under specific circumstances and for specific individuals. While your healthcare professional’s office is usually the best place to receive recommended vaccines, it is unlikely they will carry anthrax vaccine.

If anthrax vaccine is recommended or required by your employer because of your job responsibilities, you should ask your employer if they offer the vaccine or to refer you to a clinic in your community where the vaccine is available. You can also contact your state health department to learn more about where to get the vaccine in your community if it is recommended for you.

How Do I Pay for This Vaccine?

If your employer recommends or requires anthrax vaccine, you should ask if they provide the vaccine to their employees. The vaccine may also be paid for by:

Private Health Insurance

Private health insurance plans may cover these vaccines if recommended for your job or in emergency situations. Check with your insurance provider for details on whether there is any cost to you and for a list of in-network vaccine providers.

• CDC’s Anthrax Website
• Educational Materials on Anthrax
• Anthrax Vaccine Information Statement (English / Other Languages)
• Vaccine Safety
  • CDC’s Vaccine Safety Website
  • Frequently Asked Questions about Vaccine Safety

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Anthrax Vaccine Information Statement | CDC

Current Edition Date: 1/8/2020

• Print VIS [2 pages]
• RTF file [3 pages]
  (For use in electronic systems)

• VIS in other languages
• More information about anthrax vaccination

• Why get vaccinated?
• Adenovirus vaccine
• Talk with your health care provider
• Risks of a vaccine reaction
• What if there is a serious problem?
• Countermeasures Injury Compensation Program
• How can I learn more?

Anthrax vaccine can prevent anthrax.

People can get anthrax disease from contact with infected animals or contaminated animal products such as wool, meat, or hides. The anthrax bacteria could also be used as a biological weapon.

Anthrax is not spread from person to person. It is spread in one of four ways, and signs and symptoms can vary depending on how anthrax enters the body:

• Through breaks in the skin. Cutaneous anthrax causes blisters or bumps on the skin, swelling around the sore, and a painless skin sore (ulcer) with a black center. The sore is usually on the face, neck, arms, or hands.
• From eating infected meat. Ingestion anthrax can cause fever and chills. It can affect the upper part of the gastrointestinal (GI) tract, the lower part of the GI tract, or both. When it affects the upper part, there is swelling of the neck or neck glands, sore throat, and painful swallowing or difficulty breathing. When it affects the lower GI tract, nausea and vomiting, stomach pain and swelling, and diarrhea may be present. The patient may also look flushed (red), have red eyes, or faint.
• From inhaling spores of the bacteria that causes anthrax. Inhalation anthrax can cause shortness of breath, cough, chest discomfort, confusion, nausea or vomiting, stomachache, sweats, and dizziness.
• From injecting heroin. Injection anthrax can result in swelling at the injection site, nausea and vomiting, and sweats.

All types of anthrax can cause fever, chills, fatigue, and headache.  Anthrax can spread throughout the body and cause severe illness, including brain infections and even death, if left untreated.

Anthrax vaccine is approved by the Food and Drug Administration (FDA) and recommended for adults 18 through 65 years of age who are at risk of exposure to anthrax bacteria, including:

• Certain laboratory workers who work with Bacillus anthracis
• People who handle potentially infected animals or their carcasses
• Some military personnel (determined by the Department of Defense)
• Some emergency and other responders whose response activities might lead to exposure

These people should get 3 doses of anthrax vaccine, followed by booster doses for ongoing protection.

Anthrax vaccine is also recommended for unvaccinated people of all ages who have been exposed to anthrax. These people should get 3 doses of anthrax vaccine together with recommended antibiotic drugs.

Anthrax vaccine has not been studied or used in children less than 18 years of age. Because its use in exposed children is not approved by FDA, it must be used under an expanded access Investigational New Drug (IND) program and requires informed consent from a parent or legal guardian.

Tell your vaccine provider if the person getting the vaccine:

• Has had an allergic reaction after a previous dose of anthrax vaccine, or has any severe, life-threatening allergies.
• Is pregnant or thinks she might be pregnant.
• Has a weakened immune system.
• Has a history of anthrax disease.

In some cases, your health care provider may decide to postpone anthrax vaccination to a future visit.

People with minor illnesses, such as a cold, may be vaccinated. People who are moderately or severely ill should usually wait until they recover before getting anthrax vaccine.

If you are receiving the vaccine because you have been exposed to anthrax, tell your health care provider if you are not feeling well.  You might need immediate medical care.

Your health care provider can give you more information.

After getting a shot of anthrax vaccine, you may have:

• Tenderness, redness, itching, or a lump or bruise where the shot is given
• Muscle aches or short-term trouble moving your arm
• Headaches or fatigue

People sometimes faint after medical procedures, including vaccination. Tell your provider if you feel dizzy or have vision changes or ringing in the ears.

As with any medicine, there is a very remote chance of a vaccine causing a severe allergic reaction, other serious injury, or death.

An allergic reaction could occur after the vaccinated person leaves the clinic. If you see signs of a severe allergic reaction (hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, or weakness), call 9-1-1 and get the person to the nearest hospital.

For other signs that concern you, call your health care provider.

Adverse reactions should be reported to the Vaccine Adverse Event Reporting System (VAERS). Your health care provider will usually file this report, or you can do it yourself. Visit the VAERS website or call 1-800-822-7967.  VAERS is only for reporting reactions, and VAERS staff do not give medical advice.

The Countermeasures Injury Compensation Program is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines. If you have been injured by the anthrax vaccine, you can learn more about this Program by visiting the program’s website, or calling 1-855-266-2427.

• Ask your health care provider.
• Call your local or state health department.
• Contact the Centers for Disease Control and Prevention (CDC):
  • Call 1-800-232-4636 (1-800-CDC-INFO) or
  • Visit CDC’s anthrax website

Many Vaccine Information Statements are available in español and other languages. See https://www.immunize.org/vis.

Vaccine Information Statement
Anthrax Vaccine (1/8/20)

Department of Health and Human Services
Centers for Disease Control and Prevention

Office Use Only

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“Veterinaria.rf”: Oleg Sklyarov: “The cause of complications may not be a vaccine, but a violation of the rules for its use” in the soil for a long time. To prevent the disease in Russia, mass vaccination of farm animals is carried out. In the main part of them, intense immunity is created, however, post-vaccination complications are recorded in goats and some other animals.

Employees of the All-Russian State Center for the Quality and Standardization of Medicines for Animals and Feed (VGNKI) are starting a study that will improve the safety and effectiveness of immunization. Oleg Sklyarov, Doctor of Veterinary Sciences, Head of the Laboratory for the Quality and Standardization of Bacterial Medicines of the Federal State Budgetary Institution VGNKI, told us about the tasks and details of the upcoming work.

– Oleg Dmitrievich, what kind of anthrax vaccine is used today?

– Live, liquid or dry vaccine against anthrax of farm animals (large and small cattle, horses, donkeys, camels, deer, pigs, fur-bearing animals) of various domestic manufacturers, as well as associated vaccine against anthrax and emphysematous carbuncle – for cattle.

– How often are cases of post-vaccination complications recorded?

– VGNKI periodically receives data on cases of post-vaccination complications in farm animals as a result of prophylactic immunization against anthrax. This information concerns mainly goats, sometimes horses and cattle. In particular, the Committee of Veterinary Medicine of the city of Moscow and the Main Department of Veterinary Medicine of the Moscow Region reported five such cases in 2013, four in 2014 and nine in 2015. Complications were recorded after vaccination in goats in the village of Vasilievka, Voronezh region, in five cattle in Buryatia (four of them died), in four goats in the Pavlovo-Posad district of the Moscow region, where one animal died.

– Who registers cases of complications after vaccination?

– As a rule, such cases are registered by employees of the territorial departments of the Rosselkhoznadzor or the veterinary departments of the subjects. They or the owners of the affected animals bring this information to the manufacturer of the vaccine.

In addition, after the adoption of the law “On the Protection of Consumer Rights”, the proceedings in such cases are conducted between the owner and the manufacturer of the drug. VGNKI can participate and participates in arbitration testing of drug samples from the places of application. We control vaccine samples of the same series, selected from the manufacturer’s archive in accordance with the requirements of regulatory documents regulating the quality of drugs.

– Is it always possible to pinpoint the exact cause of complications?

– It is not always easy to do this, because the cause may not be a vaccine at all, but a violation of the procedure for its use prescribed in the instructions for the drug. For example, if clinically ill animals or animals with a latent form of the disease are immunized. It happens that age restrictions are not taken into account when immunizing, or they are vaccinated in the cold season.

– How good are vaccine safety practices?

– According to the requirements of regulatory documents and GOST R 52616-2006 “Vaccination against anthrax of animals from strain 55-VNIIVViM live” control of anthrax vaccines in terms of quality “harmlessness” is carried out on rabbits. According to the results of tests of reclamation and archival samples of vaccines, as well as samples tested by our organization over the past five years as part of drug monitoring and selective quality control of medicines, vaccines in terms of “harmlessness” almost always met the requirements of regulatory documents. This implies the use of another animal model, for example, sheep and (or) goats, when testing vaccines for harmlessness, which, by the way, is regulated by the Guidelines for Diagnostic Tests and Vaccines of the International Epizootic Bureau. Of course, this will affect the cost of control and the price of the vaccine.

– What was the prerequisite for new research work in this direction?

– The problem with the immune status of goats, resulting from the vaccination of animals against anthrax and sometimes leading to their death, causes dissatisfaction with the owners. Complaints and reports of cases of post-vaccination complications are periodically received. Therefore, the question arose of the need to improve the methods of quality control of anthrax vaccines. The Scientific and Technical Commission of the Rosselkhoznadzor approved the program and stages of research work, the purpose of which is to increase the effectiveness and safety of the anthrax vaccine used in Russia.

– What tasks are planned to be solved within the framework of this work?

– First of all, it is necessary to determine the sensitivity of goats of various breeds to anthrax vaccines of domestic manufacturers, taking into account local and general reactions of the body in the post-vaccination period. It is also necessary to establish the optimal immunizing dose and develop a scheme for immunizing goats against anthrax. This will take into account the results of studying the sensitivity of animals to cultures of different vaccine strains. Another task is to improve the method of quality control of anthrax vaccines in terms of “harmlessness”.

– How much time is devoted to these tasks?

– The work is planned for the period from 2019 to 2021. Its responsible executor is the deputy head of the laboratory for the quality and standardization of bacterial medicines of the Federal State Budgetary Institution “VGNKI”, candidate of veterinary sciences, associate professor Lusine Hamletovna Tsaturyan, who specializes in the study of this zoonosis. Researchers and junior staff of this laboratory will participate in the work.

Scientists will have to monitor the content of antibody titer in the blood of vaccinated animals. Representatives of all breeds of goats that are found on the territory of our country will take part in the tests.

– How will the results be used?

– Upon completion of the research work, an optimal scheme for immunizing goats and other animals against anthrax will be proposed and appropriate methodological recommendations will be given. The results obtained will serve as the basis for making changes to GOST R 52616-2006, as well as to the regulatory documents of vaccine manufacturers, subject to their consent. Research aimed at improving the efficacy and safety of anthrax vaccines should help overcome the reluctance of owners to vaccinate animals against anthrax, as well as their mistrust of veterinarians.

It is worth noting that this urgent problem should be solved as quickly as possible. Moreover, its decision depends not only on VGNKI specialists, but also on vaccine manufacturers, the country’s veterinary services, regardless of their departmental subordination, as well as on animal owners. Joint efforts of all interested parties are needed. Inaction will contribute to the persistence of the risk of new anthrax outbreaks with all the negative consequences inherent in this.

lyophilizate for the preparation of a suspension for subcutaneous administration and skin scarification application

0.004 ‰

Analogs

All forms of release, dosages, registration certificates, drug manufacturers, drug characteristics

Live anthrax vaccine (lyophilizate for preparation of suspension for subcutaneous injection and skin scarification application), instructions for medical use RU No. Р N001273/01

Last modified: 10/16/2019

Contents

• Active substance
• ATX
• Pharmacological group
• Dosage form
• Compound
• Description of the dosage form
• Indications
• Contraindications
• Use during pregnancy and lactation
• Dosage and administration
• Side effects
• Interaction
• Overdose
• special instructions
• Release form
• Terms of dispensing from pharmacies
• Storage conditions
• Best before date
• Reviews

Active ingredient

Anthrax vaccine (Vaccine anthrax)

ATX

J07AC Anthrax vaccines

Pharmacological group

Vaccines, sera, phages and toxoids

Dosage form

Lyophilisate for
preparation of a suspension for subcutaneous administration and skin scarification
application.

Composition

Single dose
contains:

Valid
substance:

Spores Bacillus
anthracis STI-1 – from 400 to 600 million spores in 0.05 ml for cutaneous
scarifying application or from 40 to 60 million spores in 0.5 ml for
subcutaneous injection;

Auxiliaries
substances (for
skin scarification application):

sucrose —
10 mg;

glycerol —
0.015 ml;

water for
injections – up to 0.05 ml;

Auxiliaries
substances (for
subcutaneous administration):

sucrose —
1 mg;

sodium chloride —
4.5 mg;

water for
injections – up to 0.5 ml.

Dosage form description

Porous mass
grayish-white or yellowish-white with a brownish tint.
The reconstituted preparation is an opaque homogeneous suspension of grayish-white
or yellowish-white color without foreign inclusions.

Indications

Prevention
anthrax in adults and children over 14 years of age subject to mandatory
vaccinations:

–
face,
working with live cultures of the anthrax pathogen, with infected
laboratory animals or performing research on materials contaminated
or suspected of being infected with anthrax;

–
face,
professionally engaged in keeping livestock, as well as slaughtering livestock,
engaged in procurement, collection, storage, transportation, processing and
sale of raw materials of animal origin;

–
face,
performing agricultural, irrigation and drainage, construction, excavation and
soil movement, harvesting, commercial, geological,
surveying, expeditionary in the territories enzootic for anthrax.

Contraindications

–
increased
sensitivity to any of the components of the vaccine;

–
heavy
reaction or complications to a previous vaccine administration;

–
age
up to 14 years;

–
sharp
infectious and non-communicable diseases, chronic diseases in the stage
exacerbations – vaccinations are carried out no earlier than after 1 month. after
recovery;

–
primary
and secondary immunodeficiencies. In the treatment of steroids, antimetabolites, chemotherapy and
X-ray therapy, vaccination is carried out no earlier than after 6 months. after
end of treatment;

–
malignant
neoplasms and malignant diseases of the blood;

–
systemic
connective tissue diseases;

–
common
recurrent skin diseases;

–
diseases
endocrine system;

–
pregnancy
and the period of breastfeeding.

Each
in a separate case for diseases not included in this list,
Vaccination is carried out only with the permission of the relevant medical specialist.

With purpose
identification of contraindications, the doctor (paramedic) on the day of vaccination conducts a survey and
examination of vaccinated with mandatory thermometry.

Use during pregnancy and lactation

Contraindicated
the use of the drug during pregnancy and during breastfeeding.

Dosage and Administration

Information for healthcare professionals only.
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Vaccination
carried out by paramedical personnel under the guidance of a doctor.

Primary
immunization is carried out twice by scarification method with an interval
20-30 days or subcutaneously. Revaccination is carried out once
annually subcutaneously.

Vaccination according to
epidemiological indications are carried out subcutaneously. If necessary
revaccination is carried out once annually by the subcutaneous method.

Vaccination
scarification (skin) method

Before
using each ampoule (vial) with the vaccine is carefully examined. Not
the vaccine is to be used if the integrity of the ampoule (vial) is damaged,
change in the appearance of the dry and dissolved drug (presence of foreign
inclusions, non-breakable lumps and flakes), no label, expiration
expiration date, violation of storage conditions.

Based on
the number of vaccination doses, the contents of the ampoule (vial) immediately before
resuspended in a solvent – a sterile 30% aqueous solution
glycerol using a syringe with an intramuscular needle (0.8 ×
40). In an ampoule (bottle) with 10 skin doses, 0.5 ml is added, and with 20
skin doses – 1.0 ml of solvent and shake until formation
homogeneous suspension of grayish-white or yellowish-white color. Dissolution time
vaccine should not exceed 5 minutes. Reconstituted vaccine stored in
aseptic conditions, can be used within 4 h.

Inoculation
produce on the outer surface of the middle third of the shoulder. Place of inoculation
treated with 70% alcohol. The use of other disinfectant solutions is not
allowed. After evaporation of the alcohol with a sterile tuberculin syringe with a thin
and a short needle (0.4 × 15), without touching the skin, apply one drop at a time
(0.025 ml) of the diluted vaccine in 2 places for future notches at a distance
3-4 cm on the horizontal surface of the shoulder. skin lightly
pull and sterile smallpox pen through each drop of vaccine
make 2 parallel notches (at a distance of 3-5 mm) 10 mm long
in such a way that they do not bleed (blood can only act as
small dewdrops). With the flat side of the smallpox pen, the vaccine is rubbed into
notches for 30 s and allowed to dry for 5-10 minutes. For
each vaccinated use a separate disposable pen. Forbidden instead
feathers to use needles, scalpels, etc.

Vaccination
subcutaneously

Preparation
immediately before use, resuspend in 1 ml of sterile 0.9%
sodium chloride solution. The ampoule (vial) is shaken until a uniform
grayish-white or yellowish-white suspensions. Ampoule content
(vial) is transferred with a sterile syringe into a sterile vial with a 0. 9% solution
sodium chloride for injection. In the case of using an ampoule (vial),
containing 200 subcutaneous vaccination doses, the suspension is transferred into a vial with
99 ml, and containing 100 subcutaneous vaccination doses – in a vial with 49 ml
solvent.

With syringe
method, the vaccine in a volume of 0.5 ml is injected subcutaneously into the region of the lower angle
shoulder blades. The skin at the injection site is treated with 70% alcohol. Before every selection
Shake the vaccine vial. The injection site is treated with 70% alcohol.

With needleless
method, the vaccine in a volume of 0.5 ml is injected into the area of ​​the outer surface
upper third of the upper arm with a needleless injector with a protector in strict compliance with
instructions for its use. Place of administration of the vaccine before and after the injection
processed, as in the subcutaneous method.

Unused
vaccine, used vaccination disposable syringes and pens are subject to
mandatory inactivation by autoclaving at 132 ± 2 °C and
pressure 2. 0 kgf/m ² for 90 min.

Parts
needleless injector that came into contact with the vaccine is immersed in a 6% solution
hydrogen peroxide with 0.5% detergent such as “Progress” or “Astra” on
1 hour at a temperature not lower than 50 °C. The solution is used once.
Then the pre-sterilization treatment of the injector is carried out:

a) rinsing
under running water for 0.5 min;

b) soaking at
fully immersed in a cleaning solution at 50°C for 15 minutes.
Recipe for 1 liter of cleaning solution: 17 g perhydrol (27.5 g 33%
hydrogen peroxide), 5 g detergent and 978 ml water;

c) washing in detergent
solution with a brush or cotton-gauze swab of each item for
0.5 min;

g) rinsing
under running water for 10 minutes;

e) rinsing
distilled water for 0.5 minutes of each item;

f) dry to full
disappearance of moisture.

Sterilization
parts of a needleless injector are carried out by autoclaving at a temperature
132 + 2 °С and pressure 2. 0 kgf/m ² during
90 min.

Side effects

Vaccinations
vaccine may be accompanied by local reactions, the intensity of which depends
from the individual characteristics of the vaccinated. 24-48 hours after cutaneous
vaccination at the injection site, hyperemia, infiltration with
subsequent formation of yellowish crusts along the notches. Through
24-48 hours after subcutaneous vaccination at the injection site, there may be
soreness, hyperemia, less often – an infiltrate with a diameter of up to 50 mm. side
the effect of the drug can manifest itself in the first day after vaccination with malaise,
headache and fever up to 38.5 °C.

Interactions

Information for healthcare professionals only.
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Interval between
anthrax vaccination and other vaccines should not be
less than one month, and in relation to children’s contingents – at least two
months. The vaccine is sensitive to antibiotics, and therefore immunization for
against the background of taking antibiotics is not allowed.

Overdose

Symptoms
overdose has not been established, no cases of overdose have been identified.

Special instructions

Absolutely
vaccine diluted for skin scarification application is prohibited
inject subcutaneously!

Vaccination
it is desirable to carry out in the first quarter of the year, since the most dangerous in
regarding anthrax infection is the spring-summer season.

Not subject to
use of a vaccine, the integrity of the packaging of which is damaged, with altered
physical properties, expired, in violation of the regime
storage.

Opening of ampoules and
the procedure for administering the drug is carried out with strict observance of the rules
asepsis. Reconstituted vaccine must be used within 4 hours.

Unused
vaccine, used vaccination disposable syringes and pens are subject to
special processing (see section “Method of application and doses”).

Before administration
vaccines conduct a medical examination to identify contraindications for
vaccination.

Venues
vaccinations should be provided with anti-shock therapy.

Vaccinated
must be under medical supervision for at least 30 minutes after
introduction of the vaccine.

Conducted
vaccination is registered in the established accounting forms indicating the name
drug, date of vaccination, dose, manufacturer’s name, batch number and
reactions to vaccine administration.

Influence
drug on the ability to drive vehicles,
mechanisms

Impact data
the drug on the ability to drive or engage in other
potentially hazardous activities requiring increased concentration
attention and speed of psychomotor reactions are absent.

Release form

First release form. 200 each
subcutaneous or 20 skin vaccination doses in ampoules ShP-5, ShP-6 (AShPV-6)
from glass NS-1, NS-2, NS-3 or in FO-10 bottles from a glass tube for
medicines. Vials are sealed with rubber stoppers type 1-1 or
designs 2, which are clamped with aluminum caps. 1.5 ml
solvent – glycerol solution 30% in ampoules ShP-5, ShP-6 (AShPV-6) from
glasses NS-1, NS-2, NS-3.

Second form
release.
100 subcutaneous or 10 skin vaccination doses in ampoules ShP-5, ShP-6
(ASHPV-6) from glass NS-1, NS-2, NS-3 or in FO-10 bottles from a glass tube
for medicines. Vials are sealed with rubber stoppers type 1-1
or designs 2, which are clamped with aluminum caps. 1.0 ml
solvent – glycerol solution 30% in ampoules ShP-5, ShP-6 (AShPV-6) from
glasses NS-1, NS-2, NS-3.

Pack of 5 ampoules
or vials with a vaccine, 5 ampoules with a solvent, instructions for use,
ampoule knife.

Terms of dispensing from pharmacies

For
treatment-and-prophylactic and sanitary-and-prophylactic establishments.

Storage conditions

Storage conditions
and transport

Store in
in accordance with SP 3.3.2.3332-16 at a temperature of 2 to 8 °C, out of reach
place for children.

Transported to
in accordance with SP 3.