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Transcript
Adacel Quadra™ – A new combination vaccine for use as booster in children from 6 years of age, adolescents and adults There has been a resurgence in the incidence of pertussis in several countries. There has also been a shift in the age distribution of pertussis, with dramatic increases being reported among adolescents and adults. It appears, therefore, that immunity to pertussis, whether acquired from natural infection during childhood or whether acquired from routine infant immunisation, may not be lifelong. Indeed, it has been shown that the duration of protection from both whole cell and acellular pertussis vaccine is six years, while natural infection may provide protection for up to 15 years. There is clearly a need for a pertussis booster to be added to the low-dose diphtheria, tetanus and poliomyelitis (e.g. TdPolio®) booster currently recommended for adults, adolescents and children over six years of age. Td Polio® is no longer available, and therefore Adacel Quadra™ can be used in place of Td Polio®. Approved indication Adacel Quadra™is a component pertussis vaccine, with diphtheria and tetanus toxoids adsorbed, and inactivated poliomyelitis vaccine. It is indicated for use as a booster in children from six years of age, adolescents and adults. Adacel Quadra™ is not intended for primary immunisation or as a booster in children less than three years of age. Mode of action The combination vaccine is an active immunising agent against diphtheria, pertussis, tetanus and poliomyelitis. Dosage One dose (0.5 ml) administered by intramuscular injection, usually into the deltoid region. The deep subcutaneous route can also be used. Evidence of efficacy Immunogenicity studies in children from the age of 6 years, adolescents and adults have shown that Adacel Quadra™ induces high antibody response rates to all components of the vaccine. The immunogenicity profile has been shown to be comparable to that observed with single dose boosters of diphtheria-tetanus vaccine or with diphtheria-tetanus-inactivated polio vaccine containing similar amounts of tetanus and diphtheria toxoids and inactivated polio virus type 1, 2 and 3.1 Serological correlates for protection against pertussis have not yet been established. However, based on two studies with acellular pertussis (i.e. infant DTaP), which conferred a protective efficacy of 85% against pertussis disease, Adacel Quadra™ is considered to elicit a protective immune response against pertussis (seroprotection rates three years post-vaccination of > 96%).1 Reference: 1. Adacel TM Quadra package insert. 44 Precautions o General Hypersensitivity to the active substances or to any of the other excipients of the vaccine. Anaphylactic reaction to a previous dose of vaccine containing any of the active substances contained in Adacel Quadra™. Evolving encephalopathy – Adacel Quadra™ should not be given to patients who previously experienced an encephalopathy of unknown origin within 7 days of previous immunisation with a pertussis-containing vaccine. Adacel Quadra™ should not be given to patients with progressive or unstable neurological disorder or uncontrolled epilepsy until the condition has stabilised. Vaccination should be deferred in the presence of acute illness, including febrile illness. o Pregnancy and lactation There is no data on the use of acellular pertussis vaccines in pregnancy. The use of this vaccine is not recommended during pregnancy or lactation. Major adverse effects In order to minimise the risk of adverse reactions, the interval between a booster dose of Adacel Quadra™ and preceding booster doses of diphtheria and tetanus-containing vaccines should be at least five years. Most commonly reported adverse reactions include local reactions at the injection site (pain, redness and swelling). These signs and symptoms are usually mild and resolve without sequelae. Other common adverse effects reported include headache, nausea, vomiting, diarrhoea, joint or muscle pain, weakness, chills, fatigue and fever. Drug interactions Adacel Quadra™ is an inactivated vaccine and theoretically there is no reason why it should not be administered at the same time as other vaccines or immunoglobulins, at different sites. Cost: SEP (Excl. VAT) R185.00 Presentation Adacel QuadraTM is presented as a suspension, single dose (0.5ml) pre-filled syringe, co-packed with two needles. Patient information In order to minimise the risk of adverse reactions, the interval between a booster dose of Adacel Quadra™ and preceding booster doses of diphtheria and tetanus-containing vaccines should be at least five years. Conclusion Immunity acquired through childhood vaccination or natural exposure wanes over time. Therefore, there is a need for a single-dose booster of pertussis, diphtheria, tetanus and poliomyelitis vaccine, which may be administered to children from six years of age, adolescents and adults. Manufactured by Sanofi-Pasteur.Distributed by UTI Pharma, also available in other wholesalers. SA Pharmaceutical Journal – November/December 2009