What is the recommended use and administration of BOOSTRIX (Tdap vaccine) 0.5ML?

BOOSTRIX 0.5ML Vaccine Administration and Recommendations

BOOSTRIX is a single-dose 0.5mL Tdap vaccine administered intramuscularly for booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older. 1, 2

General Administration Guidelines

• BOOSTRIX contains reduced quantities of tetanus toxoid, diphtheria toxoid, and three pertussis antigens (pertussis toxin, filamentous hemagglutinin, and pertactin) 3
• Available in either prefilled disposable syringes without needles (contains latex in tip cap and rubber plunger) or single-dose vials (latex-free) 4
• Administered as a single 0.5mL intramuscular injection 1
• Contains aluminum as an adjuvant and no thimerosal 4

Age-Specific Recommendations

• Originally licensed in 2005 for persons aged 10-18 years 2
• FDA expanded approval in 2008 for persons aged 19-64 years 2
• Further expanded in 2011 to include persons aged 65 years and older 2
• Not licensed for use in children younger than 10 years 4

Indications for Use

• Primary indication: Single-dose booster vaccination against tetanus, diphtheria, and pertussis in individuals ≥10 years who have completed their primary immunization series 1, 3
• Can be used to replace one dose of Td (tetanus and diphtheria) in the 3-dose primary series for adults who have not completed primary immunization 4
• Can be administered to adults who have close contact with infants <12 months (e.g., parents, grandparents, childcare providers) to reduce risk of pertussis transmission 4
• Appropriate for use in pertussis outbreak situations 4

Timing of Administration

• Typically administered at least 5 years after the last tetanus and diphtheria toxoid-containing vaccine 4
• In situations with increased risk of pertussis or its complications, intervals shorter than 5 years may be used 4
• Safety of an interval as short as approximately 2 years between Td and Tdap is supported by clinical evidence 4

Special Situations

• Wound management: BOOSTRIX can be used instead of Td for tetanus prophylaxis in wound management if the person has not previously received Tdap 4
• Co-administration: Can be safely administered with other vaccines; simultaneous administration with meningococcal conjugate vaccine (MCV4) is preferred when both are indicated 4
• If simultaneous administration with MCV4 is not feasible, they can be administered using any sequence 4
• Pregnancy: As with other inactivated vaccines, pregnancy is not considered a contraindication for Tdap vaccination 4

Contraindications

• History of serious allergic reaction (anaphylaxis) to any component of the vaccine 4
• History of encephalopathy within 7 days of a previous pertussis-containing vaccine not attributable to another cause 4

Common Adverse Events

• Pain at the injection site is the most common adverse event (reported in 75% of recipients) 4
• Severe pain (defined as pain at rest or pain that prevented everyday activities) occurs in approximately 4.6% of recipients 4
• Other common local reactions include redness, swelling, or increased mid-upper arm circumference (20-30% of recipients) 4
• Common systemic adverse events include headache (42-43%) and fatigue (37%) 4
• Most adverse events are mild to moderate in intensity and transient 3

Important Considerations

• After receiving BOOSTRIX, subsequent tetanus and diphtheria protection should be maintained with Td boosters every 10 years 4
• BOOSTRIX is not licensed for multiple administrations; after receipt of BOOSTRIX, subsequent doses should be Td 4
• If BOOSTRIX is inadvertently administered to an adult who has previously received Tdap, this dose should count as the next dose of tetanus toxoid-containing vaccine 4
• Antibody levels against pertussis begin to decline by 5 years after vaccination, but a subsequent booster dose 10 years later has been shown to be immunogenic and well-tolerated 3

Clinical Efficacy

• In clinical trials, a single booster dose of BOOSTRIX induced seroprotective levels of antibodies to diphtheria and tetanus toxoids in virtually all recipients 3
• Seropositivity rates for antibodies against pertussis antigens were ≥90% across all age groups 3
• The immune response to BOOSTRIX in adolescents was noninferior to that seen in infants who received three doses of the pediatric DTaP vaccine (Infanrix) in efficacy trials 4