Manufacturer: Pfizer Labs Pharmacological Class: PCV Active Ingredient(s): Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) 30.8micrograms of saccharides per 0.5mL; susp for IM inj; contains aluminum. Indication(s): Immunization of children age 6 weeks to 5 years (before 6th birthday) against invasive disease caused by S. pneumoniae due to serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F; and against otitis media due to serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. Pharmacology: Prevnar 13 is a vaccine comprised of 13 pneumococcal serotype polysaccharides conjugated to the protein carrier diphtheria CRM197. Prevnar 13 contains the same seven S. pneumoniae serotypes found in Prevnar plus an additional six serotypes (1, 3, 5, 6A, 7F, and 19A). Clinical Trials: The efficacy of Prevnar 13 against invasive pneumococcal disease was inferred from a randomized, double-blind, active-controlled non-inferiority trial in 2-month old infants that compared the immunogenicity of Prevnar 13 to the 7-valent pneumococcal conjugate vaccine, Prevnar. The non-inferiority criterion for the percentage of subjects with pneumococcal anti-capsular polysaccharide IgG antibody concentrations ≥0.35microgram/mL one month after the third dose was met for 10 of the 13 serotypes, with the exception of serotypes 6B, 9V, and 3. Although the response to serotypes 6B and 9V did not meet the pre-specified criterion, the differences were marginal. Antibody concentrations after dose four were higher for all 13 serotypes than those achieved after the third dose. The non-inferiority criterion for pneumococcal anti-capsular polysaccharide geometric mean concentrations after four doses was met for 12 of the 13 pneumococcal serotypes, but was not met for the response to serotype 3. Legal Classification: Rx Adults: Not recommended. Children: Each dose is 0.5mL IM into the anterolateral thigh for infants or the deltoid muscle for toddlers and children; avoid nerves and blood vessels. May pretreat with antipyretic. <6weeks: not recommended. ≥6weeks: 4 doses usually given at 2, 4, 6, and 12–15 months of age (may start at 6 weeks of age: give 1st three doses 4–8 weeks apart, and 4th dose at least 2 months after 3rd dose). Previously unvaccinated older infants and children: 7–11 months of age: 3 doses (2nd dose at least 4 weeks after 1st dose, 3rd dose after 1st birthday and at least 2 months after 2nd dose); 12–23months of age: 2 doses at least 2 months apart; 2–5yrs of age: 1 dose once. Previously vaccinated with Prevnar: may complete 4-dose series with Prevnar 13; if series is completed and 15months–5years of age: may receive 1 dose of Prevnar 13, given at least 8 weeks after 4th dose of Prevnar. Contraindication(s): Allergies to any diphtheria toxoid-containing vaccine. Precaution(s): Immunocompromised: may get suboptimal response. Not a substitute for diphtheria, or for 23-valent polysaccharide pneumococcal vaccinations. Have epinephrine inj available. Premature infants. Pregnancy (Cat.C). Nursing mothers. Interaction(s): Immunosuppressants: may get suboptimal response. Adverse Reaction(s): Inj site reactions, fever, decreased appetite, irritability, increased or decreased sleep, drowsiness, diarrhea, vomiting, rash, hives. How Supplied: Pre-filled syringe—10 Last Updated: 7/29/2010 辉瑞畅销儿童疫苗Prevnar的最新一代产品——Prevnar 13已通过了FDA的批准，该疫苗用于儿童免疫接种，预防由13种血清型肺炎链球菌导致的侵入性疾病和中耳炎。辉瑞通过收购惠氏而相应得到了这种疫苗的许可权。   　　由肺炎球菌导致的侵入性疾病包括：脓血症及菌血症、脑膜炎、菌血性肺炎和肺部蓄脓症。这次Prevnar 13获准的依据是一项7000名婴幼儿及儿童参加的III期临床实验。   　　本来该药的最终审批时间为去年9月30日，但FDA要求辉瑞进一步递交药物的生产信息，因此12月30日才作出了最终的批准决定，整个审批时间延长了90 天。而且作为批准条件之一，辉瑞还需对药物进行售后监测，包括对药物展开一项安全性研究项目，进行一项临床实验以检测疫苗对所有侵入性肺炎球菌引起的疾病的预防作用及对中耳炎的治疗效果。