Boostrix Vaccine Description 2023
Boostrix is a Tdap vaccine for preventing tetanus, diphtheria, and pertussis in people at least ten years old. This vaccine is also available for adults who need a booster. Most people in these age groups require only one Tdap shot for added protection against these diseases. Boostrix contains inactive substances produced by the bacteria that cause tetanus and diphtheria. Boostrix also includes fragments of the bacteria that cause pertussis (whooping cough).
Since 2012, the U.S. Centers for Disease Control and Prevention (CDC) has recommended using Tdap vaccines during the third trimester of each pregnancy.
And on October 7, 2022, the U.S. Food and Drug Administration (FDA) announced the approval to use Boostrix during the third trimester of pregnancy specifically to prevent pertussis in infants younger than two months. When the Boostrix vaccine is given during pregnancy, it boosts antibodies in the mother, which are transferred to the developing baby.
The FDA granted these approvals to GlaxoSmithKline Biologicals.
Boostrix Vaccine Indication
The FDA approved Boostrix in 2005 as a single dose for booster immunization against tetanus, diphtheria, and pertussis in individuals 10 through 18 years of age. Subsequently, the FDA also approved Boostrix to include use in individuals 19 years of age and older and to include the use of an additional dose 9 years or more after the initial dose of a Tdap vaccine.
Boostrix Vaccine Dosage
Boostrix is administered as a single 0.5-mL intramuscular injection into the upper arm muscle and is approved for use as a single dose in individuals ten and older. Boostrix is generally given whenever a booster dose of diphtheria and tetanus vaccine is required and where a booster for pertussis is desired. It may also be given in the case of a tetanus-prone injury where a booster for diphtheria and pertussis is also required, provided no previous dose of tetanus vaccine was given within five years previously.
Boostrix Vaccine News - 2022
October 7, 2022 - The U.S. FDA approved using Boostrix for immunization during the third trimester of pregnancy to prevent pertussis, commonly known as whooping cough, in infants younger than two months of age.
February 2012 - The ACIP vaccine committee recommended Tdap for all adults 65 and older.
July 2011 - The U.S. Food and Drug Administration (FDA) approved expanding the age indication for Boostrix to age 65.
Boostrix Vaccine Clinical Trials
A clinical trial, Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination in Study NCT01267058, assessed the efficacy and safety of repeating Tdap booster in adults ten years after previous booster vaccination with Tdap in an earlier clinical study. Before the decennial booster, 89.4% and 94.8% of subjects were seroprotected (antibodies ≥0.1 IU/mL) for diphtheria and tetanus, respectively. One-month post-booster, all subjects were seroprotected/seropositive against all vaccine antigens.
GSK's Boostrix vaccine has been involved in over 140 clinical trials.