Adis, a Wolters Kluwer Business, 41 Centorian Drive, Mairangi Bay, Auckland, New Zealand.
Paediatr Drugs. 2011 Apr 1;13(2):133-5. doi: 10.2165/11206990-000000000-00000.
Covaxis® (also licensed as Triaxis® or Adacel® in individual countries) is a Tdap₅ (i.e. combined tetanus toxoid, reduced diphtheria toxoid, five component acellular pertussis [namely detoxified pertussis toxin, filamentous hemagglutinin, pertactin, and fimbriae types 2 and 3]) vaccine for the prevention of diphtheria, tetanus, and pertussis. It is approved for use in Europe as a single intramuscular booster dose in children (aged ≥4 years), adolescents, and adults, and in the US it is approved for use in individuals aged 11-64 years. In large, randomized, controlled clinical trials conducted in the UK and North America, a single intramuscular booster dose of Covaxis® induced robust immune responses for all of its component antigens when given to children (aged ≥4 years), adolescents, and adults. In addition, Covaxis® vaccine was safe and generally well tolerated in terms of solicited and unsolicited local injection-site and systemic adverse events, most of which were of mild intensity and resolved without sequelae. Furthermore, the immunogenicity of each individual component and the reactogenicity of Covaxis® vaccine in children, adolescents, and adults was generally similar to that of comparator vaccines. Despite being a vaccine-preventable disease and having >90% primary vaccination coverage worldwide, pertussis remains uncontrolled, particularly amongst adolescents and adults. Given the changing epidemiology of pertussis and the requirement to reduce infection in adolescents and adults (including healthcare workers) and thereby prevent transmission of the disease from these individuals to very young infants, the new 'cocoon strategy' recommended in current vaccination guidelines has become a key strategy in the management of morbidity and mortality associated with pertussis. This strategy focuses on the immunization of healthcare workers, and the parents and family members of infants who are too young to have undergone primary immunization, so as to prevent the transmission of pertussis to these young at-risk infants. The implementation of the 'cocoon strategy' may finally give countries the ability to control pertussis infections in these at-risk infants and ultimately provide the desired herd immunity against pertussis. In line with this strategy, a booster dose of Covaxis® vaccine provides a valuable option to reduce pertussis morbidity and mortality, and to maintain seroprotection against diphtheria and tetanus in children (aged ≥4 years), adolescents, and adults.
Covaxis®(在个别国家也称为 Triaxis®或 Adacel®)是一种 Tdap₅(即破伤风类毒素、无细胞百日咳白喉联合疫苗[含已解毒的百日咳毒素、丝状血凝素、丝状血细胞黏附素和菌毛 2 型和 3 型])疫苗,用于预防白喉、破伤风和百日咳。该疫苗在欧洲被批准用于 4 岁以上儿童、青少年和成人的肌肉内加强免疫,在美国被批准用于 11-64 岁人群。在英国和北美的大型、随机、对照临床试验中,Covaxis®肌肉内加强免疫单剂在儿童(≥4 岁)、青少年和成人中可诱导针对所有成分抗原的强劲免疫应答。此外,Covaxis®疫苗在儿童、青少年和成人中安全性良好,一般对注射部位局部和全身不良事件的自报和非自报均具有良好耐受性,大多数不良事件为轻度,且无后遗症。此外,该疫苗每个成分的免疫原性和 Covaxis®疫苗的反应原性在儿童、青少年和成人中通常与对照疫苗相似。尽管百日咳是一种可通过疫苗预防的疾病,且全球 90%以上的人都进行了基础免疫接种,但该病仍未得到控制,尤其是在青少年和成人中。鉴于百日咳的流行病学变化,且需要减少青少年和成人(包括医护人员)中的感染,从而防止这些人群将疾病传播给非常年幼的婴儿,当前疫苗接种指南中推荐的新“围堵策略”已成为管理与百日咳相关的发病率和死亡率的关键策略。该策略重点是对医护人员,以及未接受基础免疫的婴儿的父母和家庭成员进行免疫接种,以防止将百日咳传播给这些处于危险中的婴儿。实施“围堵策略”最终可能使各国能够控制这些高危婴儿中的百日咳感染,并最终获得针对百日咳的理想群体免疫力。Covaxis®疫苗加强免疫符合这一策略,为降低百日咳发病率和死亡率以及维持≥4 岁儿童、青少年和成人对白喉和破伤风的血清保护提供了宝贵选择。