FDA Adds New Age Indication to Sanofi Pasteur’s Adacel Tdap Vaccine Booster

Sanofi Pasteur said the FDA has green-lighted its single-dose tetanus/diphtheria/pertussis vaccine active booster (Tdap) for children as young as 10.

The vaccine was originally approved in June 2005 for patients ages 11 to 64. Prior to 2005, there were no pertussis vaccines for children older than seven, according to the Centers for Disease Control and Prevention.

The approval, announced this week, is supported by data from a Phase IV multicenter, open-label study comparing the safety and immunogenicity of Adacel in 10 and 11 year olds. The results showed comparable antibody responses and adverse events in both groups, the company, a division of French drugmaker Sanofi, said.

The expanded indication for Adacel comes “in a time when we have seen increases in reports of pertussis,” said Sanofi spokesman David Greenberg. The CDC documented 48,277 cases of pertussis and 20 deaths in 2012, mostly in infants. And in 2013, 13 states and the District of Columbia reported greater numbers of pertussis cases than the previous year.

Unlike other standard vaccines such as the MMR shot for measles, mumps and rubella, immunity to diphtheria, pertussis and tetanus requires periodic boosters. Children in the U.S. typically receive five doses of the DTaP (diphtheria, tetanus and pertussis) vaccine at two, four and six months, 15 to 18 months and four to six years, said Jason McDonald at the CDC. Boosters of Tdap are then given between 10 and 18 years of age.

Together with Sanofi, GlaxoSmithKline and MassBiologics have the entire U.S. diphtheria/pertussis/tetanus vaccine market, McDonald told Drug Daily Bulletin. In addition to Adacel, Sanofi makes Daptacel, a DTaP vaccine, which is licensed for the first four doses in children, and a DT vaccine that is given to children who can’t tolerate pertussis vaccination. — Lena Freund

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