FDA Panel Backs Whooping Cough Vaccine

A U.S. advisory panel on Tuesday recommended approval of a GlaxoSmithKline Plc vaccine for adolescents that boosts immunity against diphtheria, tetanus and pertussis, also known as whooping cough.

The Food and Drug Administration panel unanimously said the company’s studies showed the vaccine, called Boostrix, was safe and effective.The panel was set to vote later Tuesday on whether to back a rival vaccine made by Sanofi-Aventis (SASY.PA: Quote, Profile, Research). The FDA usually follows the recommendations of its advisory panels.The vaccines under review are the first to combine a vaccine against whooping cough with the routine tetanus and diphtheria booster shot given to adolescents.Whooping cough is a bacterial infection marked by severe coughing spells and a “whoop” sound when patients try to inhale.Young children are routinely vaccinated against whooping cough, but experts believe immunity diminishes by adolescence.The infection can kill infants and children, but the disease is milder in adults and adolescents. The cough can last for months in older patients, but it does not always produce the characteristic whooping sound.Health officials are concerned because reports of whooping cough and infant deaths from the disease are on the rise in the United States, and older people who carry the bacteria can easily infect children.According to the Centers for Disease Control and Prevention, there were 18,957 pertussis cases reported in 2004, up from 10,670 in 2003. Cases peaked in the 1930s, before vaccination was available, at about 270,000 cases in one year.GlaxoSmithKline is seeking U.S. permission to market Boostrix for people age 10 to 18.Sanofi-Aventis wants to sell its vaccine, called Adacel, to a larger group, ages 11 to 64.FDA reviewer Ann Schwartz said Glaxo’s studies comparing a single shot of Boostrix with a diphtheria and tetanus shot showed the new vaccine likely would protect against all three targeted diseases.While more Boostrix patients reported injection site pain, “there were no unexpected adverse events or serious safety concerns,” Schwartz said.Glaxo officials said data suggest immunity would last at least five years. Panel members urged longer post-approval studies to determine how long the effects endured and whether the vaccine was successful in halting the rise of pertussis reports.Shares of GlaxoSmithKline gained 14 cents to $48.59 in afternoon trading on the New York Stock Exchange. (Source: Reuters Health, March 2005)