The FDA has approved a combined booster vaccine for adolescents that includes a pertussis component. The May 3 approval of GlaxoSmithKline's Boostrix vaccine marks the first time a tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed, has been marketed for this age group in the United States.
The newly approved vaccine is indicated for youth 10 to 18 years of age, according to the FDA.
Although the vaccine induces an antibody response to the pertussis component that is considered "adequate," according to an FDA Talk Paper on the approval, "it is not known how long immunity to pertussis will last."
Youth who received the booster immunization in clinical trials experienced pain, redness and swelling at the injection site. The redness and swelling reaction was similar to that seen after administration of the older Td booster, but the pain reaction was more frequent with the new combination vaccine. Other side effects included headaches, fever and fatigue for a short time after injection.
Pertussis has been on the rise in America since 1976, when about 1,000 cases were reported in the United States. That figure may rise to as many as 37,000 cases this year, according to CDC data.
Epidemiologists surmise the upsurge may largely be caused by transmission from undiagnosed adolescent and adult patients to infants who are too young to begin immunizations or who are only partially through the vaccine schedule.
