ADACEL

What it is

Adacel Polio is a diphtheria-tetanus-acellular pertussis combination vaccine combined with inactivated poliovirus vaccine with a reduced content of pertussis toxoid, filamentous haemagglutinin and diphtheria toxoid compared to paediatric formulations. It is supplied in a prefilled syringe for single dose (0.5 mL) use.

Approved indications

— Active immunisation against diphtheria, tetanus, pertussis and poliomyelitis in adults, adolescents and children aged 4 years and older as a booster following primary immunisation. — Prevention of pertussis in young infants via transplacental antibody transfer when administered during pregnancy.

Dosing overview

Adacel Polio should be administered as a single injection of one dose (0.5 mL) by the intramuscular route, with the same dose applying to all age groups. The preferred site is into the deltoid muscle. Adacel Polio can be used for repeat vaccination after a previous dose of Adacel Polio or Adacel to boost immunity to diphtheria, tetanus and pertussis at 5- to 10-year intervals, with repeat vaccination performed taking into account national recommendations.

Key safety warnings

Anaphylaxis has been reported after receipt of some preparations containing diphtheria toxoid, tetanus toxoid, and/or pertussis antigens. Appropriate medical treatment and supervision should be readily available for immediate use in case of a rare anaphylactic reaction following administration of the vaccine, and adrenaline (epinephrine) injection (1:1000) must be immediately available in case of unexpected anaphylactic or serious allergic reactions. If Guillain-Barré Syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid, including Adacel Polio, should be based on careful consideration of the potential benefits and possible risks. Adacel Polio should not be administered to individuals with progressive or unstable neurological disorder, uncontrolled epilepsy, or progressive encephalopathy until a treatment regimen has been established, the condition has stabilised and the benefit clearly outweighs the risk. Syncope (fainting) can occur following, or even before, administration of injectable vaccines including Adacel Polio, and procedures should be in place to prevent falling injury and manage syncopal reactions.

Contraindications

Adacel Polio should not be administered to individuals with a history of severe allergic reaction after previous administration of the vaccine or a vaccine containing the same components or constituents, or to individuals with a history of severe allergic reaction to any component of the vaccine or residues carried over from manufacture. Adacel Polio should not be administered to individuals who experienced an encephalopathy of unknown origin within 7 days of previous immunisation with a pertussis-containing vaccine, or to individuals who have experienced other neurological complications following previous immunisation with any of the antigens in Adacel Polio. Vaccination must generally be postponed in cases of moderate or severe febrile and/or acute disease, although low-grade fever does not constitute a contraindication.

Regulatory history

Adacel Polio was first registered on the ARTG on 6 June 2006. In March 2017, the PBAC recommended a change to circumstances for National Immunisation Program listing to include vaccination of women during each pregnancy to reduce pertussis in newborn infants, on a cost-minimisation basis to Boostrix.