Triple Vaccine Boostrix Approved For Senior Patients By US FDA

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Main Category: Immune System / Vaccines
Also Included In: Regulatory Affairs / Drug Approvals;  Public Health
Article Date: 09 Jul 2011 - 17:00 PDT

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The FDA (US Food and Drug Administration) has approved the triple vaccine "Boostrix" - for tetanus, diphtheria and pertussis (whooping cough) - for individuals aged 65+ years. Boostrix is made by GlaxoSmithKline Biologicals. This is the first triple vaccine for older patients. Before Boostrix's approval, available multiple vaccines only protected against tetanus and diphtheria.

Boostrix is given as a single booster shot.

Tetanus - caused by a bacterium that lives in the soil, manure, and dust, it enters the human body usually through a deep cut and paralyses the infected person.

Diphtheria - a bacterial infection which can cause severe complications if not treated promptly, such as paralysis and heart failure. Patients experience a painful sore throat, fever, swollen glands and chills.

Pertussis, also known as whooping cough - caused by the bacterium Bordetella pertussis. Infection usually occurs during childhood, but may sometimes affect teenagers and adults. Even some people who have been immunized can become infected, although their risk is much smaller compared to those who were never immunized. Pertussis causes uncontrollable coughing, as the patient exhales during a coughing fit they make a "whoop" sound, hence the name. The pertussis rate in the USA has been going up since 2007.

Last year the State of California declared a whooping cough epidemic. Pennsylvania, Ohio, New York and Michigan reported a significant increase in the number of cases in 2010 compared to 2009.

GlaxoSmithKline today cited a study which estimates that approximately 3.3 million American adolescents and adults develop pertussis annually.

Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research, said:

"Pertussis is a highly contagious disease, and outbreaks have occurred among the elderly in nursing homes and hospitals. With this approval, adults 65 and older now have the opportunity to receive a vaccine that prevents pertussis, as well as tetanus and diphtheria."

The FDA evaluated a study involving 1,300 patients aged at least 65 years who received Boostrix. Their antibody levels were found to be comparable to those of infants who had been inoculated against pertussis. Their tetanus and diphtheria antibody levels were also comparable to those who had been given existing licensed vaccines.

The most common undesirable side effects experienced by the elderly volunteers who received Boostric were fatigue, pain at the injection site, and headache.

Since 2005, Boostrix has been approved for individuals aged 10 to 18 years. In 2009, it was approved for those aged from 19 through 64.

Leonard Friedland, Vice President, Clinical and Medical Affairs, North America, GlaxoSmithKline Pharmaceuticals, said:

"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. 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 health-care providers to make sure their vaccinations are up to date and to discuss the Centers for Disease Control and Prevention's (CDC) recommendations for preventing tetanus, diphtheria and pertussis."

Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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