Breaking news: FDA approves Boostrix to help prevent whooping cough in older adults

July 11, 2011

FDA has approved Boostrix [Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed (Tdap); GlaxoSmithKline Biologicals] for use in adults aged 65 years and older for active booster immunization against tetanus, diphtheria, and pertussis (whooping cough). This approval makes Boostrix the first Tdap vaccine approved for use by this age group.

FDA has approved Boostrix [Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed (Tdap); GlaxoSmithKline Biologicals] for use in adults 65 years of age and older for active booster immunization against tetanus, diphtheria, and pertussis (whooping cough). This approval makes Boostrix the first Tdap vaccine approved for use by this age group.

With this expanded indication, Boostrix is now approved for use as a single dose in individuals 10 years of age and older, the broadest age range for any Tdap vaccine.

The approval of Boostrix for use in adults aged 65 years and older was based on 2 clinical trials in which more than 1,100 US subjects received Boostrix.

“A growing segment of our population, adults aged 65 and older, can now help protect themselves from whooping cough, a serious and highly contagious respiratory disease,” said Leonard Friedland, vice president, clinical and medical affairs, North America, GlaxoSmithKline Pharmaceuticals, in a company press release. “Although many people may have been vaccinated against whooping cough as children, immunity can wear off over time. Adults, including those aged 65 and older, should speak with their healthcare providers to make sure their vaccinations are up to date and to discuss the Centers for Disease Control and Prevention’s recommendations for preventing tetanus, diphtheria, and pertussis.”

Whooping cough is one of the most commonly occurring vaccine-preventable diseases in the United States. In 2010, the State of California declared a whooping cough epidemic. Several other states, including Michigan, Ohio, New York, and Pennsylvania, reported increases in cases from 2009 to 2010. One study estimates that pertussis may affect as many as 3.3 million adolescents and adults in the United States each year.

Pertussis, also known as whooping cough, is a highly contagious respiratory disease characterized by severe coughing fits. Whooping cough starts off like the common cold and can turn into a persistent cough over time.

In the United States, Boostrix was first approved for individuals aged 10 to 18 years in May 2005. In December 2008, the vaccine was approved for use by adults 19 to 64 years of age in the United States. Since May 2005, more than 20 million doses of Boostrix have been distributed in the United States to help protect adolescents and adults from whooping cough, as well as tetanus and diphtheria.

In clinical studies, common adverse events were injection-site reactions (pain, redness, swelling, and increase in arm circumference), headache, fatigue, and gastrointestinal symptoms. Severe allergic reaction after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine, or to any component of Boostrix, or encephalopathy within 7 days of a previous pertussis antigen-containing vaccine is a contraindication.

The decision to give Boostrix should be based on benefits and risks if Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior tetanus toxoid-containing vaccine.