US approves GlaxoSmithKline whooping cough vaccine
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The United States approved a new vaccine for adolescents on Tuesday to fight a rise in whooping cough, a disease that is creeping back despite decades of immunizing children.
GlaxoSmithKline Plc’s Boostrix vaccine is the first to combine a booster shot against whooping cough, also known as Pertussis, with the tetanus and diphtheria boosters routinely given to adolescents.
Whooping cough is a highly contagious bacterial infection marked by severe coughing spells and a “whoop” sound when patients inhale. The disease can kill young children.
Vaccines to provide immunity against whooping cough are routinely given to children, but experts believe immunity wanes by adolescence.
While whooping cough can kill infants and children, the disease is milder in adults and teenagers. The cough can last for months in older patients, but it does not always produce the characteristic whooping sound.
Older people who carry the bacteria can easily infect young, unvaccinated children, and reports of infant deaths from the disease have been increasing.
Whooping cough cases peaked in the 1930s. Pertussis immunizations for infants and children up to age 7 were introduced in the United States in the 1940s.
According to the Centers for Disease Control and Prevention, there were 18,957 Pertussis cases reported in 2004, up from 10,670 in 2003.
Boostrix was approved for use as a single-shot booster for young people ages 10 to 18, the Food and Drug Administration said in a statement. The vaccine should be available by June, GlaxoSmithKline spokeswoman Patricia Seif said. She said she could not disclose the price.
Sanofi-Aventis is seeking FDA approval to sell a rival vaccine called Adacel to a larger group, people ages 11 to 64.
It is unknown how long immunity to whooping cough will last after a Boostrix shot, the FDA said.
Reactions can include pain, redness and swelling at the injection site. Pain was reported more frequently with Boostrix than with a tetanus and diphtheria booster shot, the FDA said. Glaxo has said the pain was mild to moderate, not severe.
Other side effects include headaches, fever and fatigue for a short period after the shot, the FDA said.
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