US FDA approves GSK's Boostrix

15 December 2008

UK drug major GlaxoSmithKline says that the Food and Drug Administration has approved its tetanus, diphtheria and pertussis vaccine Boostrix for use in adults 19 to 64 years of age. According to GSK, Boostrix offers the broadest age range of combined vaccine against these three diseases. Boostrix was previously approved as a booster for preteens and teenagers. The US Centers for Disease Control and Prevention (CDC) recently stated that most adolescents and adults have not received the recommended booster shot. Andrew Eisenberg, from the Department of Public Health and Policy, Texas A&M School of Rural Public Health, noted that "Boostrix can be given in place of one tetanus diphtheria booster for adolescents and adults, in accordance with the CDC recommendation for whooping cough protection." The approval was based on two trials involving almost 3,000 US subjects that demonstrated overall safety and immunogenicity.

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