FDA Panel Backs New Whooping Cough Vaccines

An FDA expert panel has recommended the approval of a pair of new vaccines designed to prevent whooping cough (search) in adolescents and adults.

Panelists unanimously backed the whooping cough vaccine Boostrix (search), for 10-to 18-year-olds, and Adacel, for patients between 11 and 64.

Children currently receive a combination diphtheria, tetanus, and whooping cough vaccine (DPT). Infants are typically vaccinated with three shots at 2, 4, and 6 months of age.

Whooping Cough on the Rise

But immunity to whooping cough -- also known as pertussis (search) -- and the other two diseases wanes over years, leaving teens and adults vulnerable to all three. The diphtheria and tetanus booster shots available to adolescents and adults don’t include whooping cough protection, leaving wide swaths of the population open to infection.

Whooping cough infections have steadily risen in the U.S. since the mid-1970s, with 18,000 cases reported in 2004. While the disease is typically not serious in adults, up to 75 percent of all cases in infants and children are thought to come from infected family members.

Whooping cough was a major cause of infant death in the early and mid-1900s. Today the disease still kills an average of 25 infants per year in the U.S., according to the CDC.

The vaccines are similar to shots already widely given to U.S. infants and children.

“Adding pertussis to the current tetanus and diphtheria booster shot for teens is a logical strategy to prevent this disease in adolescents,” says Colin Marchant, an adjunct associate professor at Boston University and a GlaxoSmithKline consultant, in a company statement. GlaxoSmithKline, a WebMD sponsor, makes Boostrix.

Whooping Cough Vaccine Side Effects

About two-thirds of 5,800 patients given Adacel had pain at the site of their injection, while about 5 percent had fevers after vaccination, according to data from Adacel’s manufacturer, Sanofi Pasteur.

“Most fevers were mild and short in duration,” says Luc Kuykens, MD, the company’s vice president for regulatory affairs. Rates of both of the reactions, in addition to side effects including swelling, were similar to those seen with available vaccines containing only diphtheria and whooping cough protection, the company says.

Less than 1 percent of patients had other reactions with the whooping cough vaccine, including dizziness and fainting. This is similar to reactions experienced by patients taking diphtheria and tetanus combination vaccines.

Adacel is already available in Canada and Germany.

New Frontier for Teens, Adults

The three-vaccine combination has never been routinely given to adolescents and adults. Experts urged companies to conduct follow-up studies testing the safety and effectiveness of the new whooping cough vaccines as more and more patients receive repeat booster shots every 10 years.

“I think it clearly needs to be something that is incorporated in the plans for further evaluation of these vaccines,” says Gary D. Overturf, MD, a professor of pediatrics at the University of New Mexico and chairman of the advisory panel.

By Todd Zwillich, reviewed by Michael W. Smith, MD

SOURCES: CDC. Colin Marchant, adjunct associate professor, Boston University; consultant, GlaxoSmithKline. Luc Kuykens, MD, vice president for regulatory affairs, Sanofi Pasteur. Gary D. Overturf, MD, professor of pediatrics, University of New Mexico; chairman, FDA advisory panel.