First combination vaccine approved to help protect adolescents against whooping cough
(5 May 2005: VIDYYA MEDICAL NEWS SERVICE) -- 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
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
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.
Return to Vidyya Medical News Service for 5 May 2005