FDA Approves Whooping Cough Shot for Teens
Boostrix Vaccine Combines Boosters for Whooping Cough, Tetanus, and Diphtheria
May 3, 2005 -- The FDA has approved the first combination booster vaccine for whooping cough, tetanus, and diphtheria for young adults.
The booster vaccine will be marketed as Boostrix by GlaxoSmithKline. It's intended for youths aged 10-18 years.
Currently, vaccinations against whooping cough, diphtheria, and tetanus are given in early childhood. The protection that these vaccines give generally begins to wear off after five to 10 years, according to a GlaxoSmithKline news release. The drug company says it envisions Boostrix as a replacement for diphtheria-tetanus boosters routinely given to children around ages 11-12 years, since those current boosters don't include whooping cough.
Boostrix has the same components (but in reduced quantities) as Infanrix, a diphtheria-tetanus-whooping cough vaccine for infants and young children, says the FDA.
Testing showed that adolescents' response to Boostrix was "considered adequate," says the FDA, noting that it's not known how long whooping cough immunity will last.
Not Intended as Primary Vaccine
Boostrix is a booster and is not intended as a replacement for the primary whooping cough vaccine normally given during childhood.
Boostrix has not yet been studied in people who did not complete recommended childhood vaccinations, says Barbara Howe, MD, vice president for clinical research, development, and medical affairs for Vaccines North America at GlaxoSmithKline.
About Whooping Cough
Whooping cough (pertussis) is a highly communicable respiratory tract disease. It can be especially serious among babies less than 1 year old and may even be fatal. Whooping cough can cause coughing spells and choking, making it hard to breathe.
Before the introduction of a whooping cough vaccine in the 1940s, the disease was a major cause of serious illness and death among infants and young children in the U.S., says the CDC.
In teens, whooping cough is usually less severe, but adolescents might transmit it to vulnerable infants and other family members, says an FDA news release.
After a whooping cough vaccine (combined with diphtheria and tetanus) was introduced in the 1940s, cases fell, reaching a record low of 1,010 cases in 1976, says the CDC. That's 99% lower than before the pre-vaccine peak.
The original whooping cough vaccine was developed for infants and young children.
In the last 20 years, whooping cough infection rates have been rising in very young infants who have not received all their immunizations, and in adolescents and adults, says the FDA.
According to a GlaxoSmithKline news release, almost 40% of the nearly 20,000 whooping cough cases reported to the CDC in 2004 were seen in adolescents aged 10-19.
"Even with the increase in reports among adolescents and very young infants, the number of reported cases is more than 97% lower than in the pre-vaccine area," according to the CDC's web site on whooping cough.
Boostrix Side Effects
"Adolescents who received Boostrix experienced pain, redness, and swelling at the injection site," says the FDA. Those temporary problems were comparable to what is expected with a tetanus-diphtheria vaccine.
However, pain reactions at the injection site were more frequent with adolescents who received Boostrix, says the FDA.
Other side effects included headaches, fever, and fatigue for a short period of time after the infection, says the FDA. In a clinical trial of 4,114 healthy young people aged 10-18, overall safety profiles were comparable between Boostrix and a U.S.-licensed tetanus-diphtheria vaccine, says GlaxoSmithKline. All participants in that study had completed their routine childhood vaccinations on schedule, says the drug company.
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