BOOSTRIX is a combination vaccine used to protect against three potentially serious bacterial infections: tetanus, diphtheria, and pertussis (whooping cough). It is designed as a booster vaccine, typically administered to adolescents and adults to maintain immunity against these infections. BOOSTRIX helps reduce the risk of contracting these diseases, which can cause severe complications, particularly in young children and vulnerable populations. The vaccine is administered via an intramuscular injection, usually in the deltoid muscle of the upper arm.

Pharmaceutical Properties:

• Active Ingredients: BOOSTRIX contains inactivated components from three bacteria:

  • Clostridium tetani (tetanus toxoid)

  • Corynebacterium diphtheriae (diphtheria toxoid)

  • Bordetella pertussis (inactivated pertussis toxoid and other bacterial components).

• Appearance: BOOSTRIX is a sterile, cloudy, or slightly opalescent suspension presented in a prefilled syringe.

• Formulation: Each dose of BOOSTRIX is 0.5 mL, delivered through an intramuscular injection.

• Stability: The vaccine should be stored in a refrigerator at temperatures between 2°C to 8°C (36°F to 46°F). It should not be frozen and should be discarded if frozen.

• Excipients: The formulation contains stabilizers and preservatives that ensure the vaccine's efficacy and safety during storage and use.

Indications for Use:

BOOSTRIX is indicated for the following:

1. Booster Dose for Adolescents and Adults: BOOSTRIX is primarily recommended as a booster shot for individuals aged 10 years and older to protect against tetanus, diphtheria, and pertussis. It is typically administered every 10 years after the initial childhood vaccination series.

2. Protection During Pregnancy: BOOSTRIX is recommended for pregnant women, particularly during the third trimester, to protect both the mother and newborn from pertussis (whooping cough).

3. Healthcare Workers: Individuals working in healthcare settings or those in close contact with infants and vulnerable populations may also be advised to receive BOOSTRIX as part of their vaccination regimen.

4. Wound Management: BOOSTRIX can be administered as a post-exposure vaccination in individuals who sustain injuries or wounds that may expose them to Clostridium tetani bacteria, if they have not had a tetanus booster in the past 5 to 10 years.

Mechanism of Action:

BOOSTRIX works by stimulating the immune system to produce antibodies against the bacterial toxins responsible for tetanus, diphtheria, and pertussis. The components of the vaccine (inactivated bacterial toxins) trigger an immune response in the body, leading to the production of antibodies that can neutralize these toxins.

• Tetanus Toxoid: The tetanus component induces the production of antibodies against the tetanus toxin, which can cause severe muscle spasms and other complications.

• Diphtheria Toxoid: The diphtheria component stimulates the immune system to produce antibodies against the diphtheria toxin, which can cause severe respiratory distress and other systemic effects.

• Pertussis Components: BOOSTRIX contains inactivated pertussis components, including pertussis toxoid, which helps the immune system develop immunity against whooping cough. This prevents the severe coughing fits and respiratory issues caused by Bordetella pertussis.

By stimulating the immune system, BOOSTRIX helps the body mount a defense against future exposures to these pathogens, thereby preventing the onset of disease.

Clinical Protocol in Dubai:

1. Patient Selection:

   • BOOSTRIX is recommended for individuals aged 10 years and older, who need a booster vaccination for tetanus, diphtheria, and pertussis.

   • Pregnant women should receive a dose of BOOSTRIX during the third trimester of pregnancy (preferably between 27 and 36 weeks gestation) to help protect their newborn from pertussis.

   • Healthcare workers, caregivers of infants, and individuals in high-risk environments may be advised to receive the vaccine to protect against the spread of pertussis and other related diseases.

2. Dosage and Administration:

   • Routine Schedule (10 years and older): A single dose of BOOSTRIX is given as a booster every 10 years after the initial series of childhood vaccinations.

   • Pregnant Women: One dose of BOOSTRIX is recommended during each pregnancy, ideally during the third trimester to protect the newborn from pertussis.

   • Wounds and Injuries: BOOSTRIX may be given to individuals who sustain injuries that put them at risk of tetanus, especially if they have not received a tetanus booster in the past 5–10 years.

   • Route of Administration: BOOSTRIX is administered intramuscularly, typically in the deltoid muscle of the upper arm.

3. Precautions and Contraindications:

   • Contraindications: BOOSTRIX should not be given to individuals who have had a severe allergic reaction to any component of the vaccine, including previous doses of diphtheria, tetanus, or pertussis vaccines.

   • Pregnancy: BOOSTRIX is considered safe during pregnancy and is especially recommended in the third trimester to protect both the mother and infant from pertussis.

   • Acute Illness: Individuals with moderate or severe acute illnesses or fever should defer vaccination until they have recovered.

4. Monitoring:

   • After the vaccine is administered, individuals should be monitored for at least 15 minutes for any allergic reactions, including anaphylaxis.

   • Common side effects include pain, redness, or swelling at the injection site, as well as fever, fatigue, and mild headaches.

   • Severe side effects are rare but can include allergic reactions, such as anaphylaxis, which would require immediate medical attention.

Other Characteristics:

• Adverse Effects:

  • The most common adverse effects are mild and local, such as pain, redness, or swelling at the injection site.

  • Other common side effects include low-grade fever, tiredness, headache, and muscle aches.

  • Serious side effects such as severe allergic reactions are rare but may occur. Immediate medical attention should be sought in such cases.

• Efficacy:

  • BOOSTRIX is highly effective in preventing tetanus, diphtheria, and pertussis. Studies show that the vaccine provides long-lasting immunity and significantly reduces the risk of these potentially life-threatening diseases.

  • The vaccine is particularly important for adolescents and adults, as immunity from childhood vaccines may wane over time.

BOOSTRIX is an essential vaccine for maintaining immunity against tetanus, diphtheria, and pertussis in adolescents and adults. By providing protection through a combination of inactivated bacterial components, it helps prevent these serious infections, which can cause severe health complications, particularly in infants and vulnerable individuals. Regular booster shots, particularly during pregnancy and after injuries, are important for maintaining ongoing protection. As a safe and effective vaccine, BOOSTRIX is a vital part of the immunization schedule in Dubai and around the world.