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The Boostrix vaccine has been approved for use in people aged 65 years and older to prevent tetanus, diphtheria, and pertussis, the Food and Drug Administration announced on July 8.
This is the first vaccine approved for preventing all three diseases in this age group, according to the FDA statement announcing the approval. Until this approval, the other vaccines approved people aged 65 years and older prevented tetanus and diphtheria only.
Boostrix (combined diphtheria, tetanus, acellular pertussis [adsorbed] vaccine), which is administered as a single-dose booster injection, was initially approved in 2005 for use in adolescents aged 10 through 18 years, followed by approval for use in adults aged 18 through 64 years in 2008.
The latest approval was based on a study of about 1,300 people aged 65 years and older, which determined that antibody levels to pertussis among the adults "were comparable to the levels in infants who received a closely related vaccine that was shown to prevent pertussis," the statement said. In addition, antibody responses to the tetanus and diphtheria components were comparable to the levels achieved with a licensed tetanus and diphtheria vaccine.
The most common adverse reactions reported by the older adults after receiving Boostrix were headache, fatigue, and pain at the injection site were among common adverse reactions.
Boostrix, manufactured by GlaxoSmithKline Biologicals, is a booster and is not intended for use for primary vaccination.
The Boostrix vaccine has been approved for use in people aged 65 years and older to prevent tetanus, diphtheria, and pertussis, the Food and Drug Administration announced on July 8.
This is the first vaccine approved for preventing all three diseases in this age group, according to the FDA statement announcing the approval. Until this approval, the other vaccines approved people aged 65 years and older prevented tetanus and diphtheria only.
Boostrix (combined diphtheria, tetanus, acellular pertussis [adsorbed] vaccine), which is administered as a single-dose booster injection, was initially approved in 2005 for use in adolescents aged 10 through 18 years, followed by approval for use in adults aged 18 through 64 years in 2008.
The latest approval was based on a study of about 1,300 people aged 65 years and older, which determined that antibody levels to pertussis among the adults "were comparable to the levels in infants who received a closely related vaccine that was shown to prevent pertussis," the statement said. In addition, antibody responses to the tetanus and diphtheria components were comparable to the levels achieved with a licensed tetanus and diphtheria vaccine.
The most common adverse reactions reported by the older adults after receiving Boostrix were headache, fatigue, and pain at the injection site were among common adverse reactions.
Boostrix, manufactured by GlaxoSmithKline Biologicals, is a booster and is not intended for use for primary vaccination.
The Boostrix vaccine has been approved for use in people aged 65 years and older to prevent tetanus, diphtheria, and pertussis, the Food and Drug Administration announced on July 8.
This is the first vaccine approved for preventing all three diseases in this age group, according to the FDA statement announcing the approval. Until this approval, the other vaccines approved people aged 65 years and older prevented tetanus and diphtheria only.
Boostrix (combined diphtheria, tetanus, acellular pertussis [adsorbed] vaccine), which is administered as a single-dose booster injection, was initially approved in 2005 for use in adolescents aged 10 through 18 years, followed by approval for use in adults aged 18 through 64 years in 2008.
The latest approval was based on a study of about 1,300 people aged 65 years and older, which determined that antibody levels to pertussis among the adults "were comparable to the levels in infants who received a closely related vaccine that was shown to prevent pertussis," the statement said. In addition, antibody responses to the tetanus and diphtheria components were comparable to the levels achieved with a licensed tetanus and diphtheria vaccine.
The most common adverse reactions reported by the older adults after receiving Boostrix were headache, fatigue, and pain at the injection site were among common adverse reactions.
Boostrix, manufactured by GlaxoSmithKline Biologicals, is a booster and is not intended for use for primary vaccination.
FROM THE FDA