 |
 |
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
|
T05-17 |
Media Inquiries: Lenore
Gelb |
The Food and Drug Administration (FDA) today approved the first combination vaccine that provides a booster immunization against pertussis (whooping cough) in combination with tetanus and diphtheria for adolescents. The vaccine will be marketed as Boostrix by GlaxoSmithKline (GSK) in Philadelphia, Pa.
Pertussis is a highly communicable disease of the respiratory tract that can be especially serious for infants less than one year old, and may even be fatal. Pertussis can cause spells of coughing and choking that make breathing difficult. The disease is generally less severe in adolescents, but it is thought that they might transmit the disease to susceptible infants and other family members. In the last 20 years, rates of pertussis infection have been increasing in very young infants who have not received all their immunizations and in adolescents and adults.
Boostrix is a Tetanus Toxoid (T), Reduced Diphtheria Toxoid (d) and Acellular Pertussis Vaccine (ap), Adsorbed.
Although booster vaccines for adolescents containing T and d are currently licensed and marketed for use in this age group, none contain a pertussis component. Boostrix has the same components as Infanrix, a DTaP vaccine for infants and young children, but in reduced quantities. Boostrix is indicated for use as a single booster dose to adolescents 10-18 years of age.
The efficacy of the vaccine was measured by looking at the immune response to the vaccine, as measured by antibody concentrations. The response to the T and d components was at least as good as the response to a licensed Td vaccine.
Boostrix also induced an antibody response to the pertussis component of the vaccine. The response to the pertussis component was compared to the response induced by a three dose series of Infanrix given to infants in a previous study. The response of adolescents to Boostrix was considered adequate. It is not known how long immunity to pertussis will last.
Adolescents who received Boostrix experienced pain, redness, and swelling at the injection site. The frequency of redness and swelling after Boostrix was similar to what is expected following the administration of a Td vaccine. However, pain reactions at the injection site were more frequent with those who received Boostrix. Other side effects included headaches, fever and fatigue for a short period of time after the injection.
####
RSS Feed for FDA News Releases
Get
free weekly updates about FDA press releases, recalls, speeches, testimony
and more.