Magazine article FDA Consumer

Controlling Whooping Cough Outbreaks

Magazine article FDA Consumer

Controlling Whooping Cough Outbreaks

Article excerpt

With the number of reported outbreaks of whooping cough (pertussis) on the rise in the United States, the Centers for Disease Control and Prevention (CDC) says there is a need to protect adolescents and adults, as well as children, against this highly contagious respiratory infection.

Commonly thought of as a childhood illness, pertussis actually affects people of all ages. According to the CDC, 5,000 to 7,000 cases are reported in the United States each year. Moreover, pertussis has been increasingly reported among adolescents and adults in the last several years. This is important because those who have a cough may not realize that they have pertussis and may be the primary source of infection for infants, who have the greatest risk of dying from the disease.

While there is no lifelong protection against pertussis, immunization by vaccine is the best preventive measure available. However, the only vaccine currently licensed by the Food and Drug Administration to prevent the disease is available only to children up to age 7. The vaccine is part of a routine series of childhood immunizations called diphtheria-tetanus-acellular pertussis (DTaP) that is strongly recommended by the National Immunization Program at the CDC. It is administered in five doses, given at 2, 4, 6, and 15 to 18 months of age, and between 4 and 6 years. All five doses are recommended for maximum protection.

Although most infants in the United States are immunized against pertussis, this immunity usually fades as a person enters adolescence or early adulthood. Health officials at the CDC say that preventing transmission of the disease to very young infants is critical because they are not old enough to be fully immunized. The CDC says that between 1996 and 2004 the majority of pertussis patients were either too young to have the required vaccine series or too old to have been immunized.

Two biologics companies hope to change that. The FDA's Vaccine and Related Biological Products Advisory Committee said in March 2005 that the safety and effectiveness data on two new pertussis vaccines submitted by the companies in 2004 were adequate. GlaxoSmithKline's vaccine is intended to immunize young people ages 10 to 18, while Aventis Pasteur's vaccine is indicated for those ages 11 to 64. Both would be used as booster vaccines, and experts hope it will help to reduce the incidence of pertussis in young infants as well, by decreasing their exposure to the bacteria.

The committee's recommendations are carefully taken into consideration by the FDA in making the final decision about whether or not to approve such products for use in the United States.

What Is Pertussis?

Pertussis is a respiratory system infection caused by the bacterium Bordetella pertussis. It is characterized by severe coughing spells that may end in a "whooping" sound when the infected person inhales. The first symptoms are like a cold--sneezing, runny nose, nasal congestion, slight fever, and a dry cough that may get worse at night. But unlike a cold, whooping cough sticks around, and within two weeks the symptoms get worse. A person can have fits of coughing that seem to go on and on. Severe coughing can lead to vomiting and may make it hard for a person to eat or drink. Because adults and adolescents with pertussis may have milder symptoms, they usually don't know they have the disease.

People get pertussis by breathing in tiny droplets released into the air by an infected person's cough or sneeze. Once inside the airways, pertussis bacteria produce toxins that interfere with the respiratory tract's normal ability to eliminate germs. …

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