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FDA Vaccines Committee Recommends Boostrix

PHILADELPHIA, March 15 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today announced that its booster vaccine candidate, Boostrix(TM) [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap)] received a unanimous favorable recommendation from the Vaccines and Related Biological Products Advisory Committee of the U.S. Food and Drug Administration (FDA). Currently, there is no pertussis vaccine approved for use in the U.S. for children seven years of age or older. Immunity from childhood vaccination generally wears off after five to 10 years, leaving many adolescents susceptible to this highly contagious disease. If approved, Boostrix would add a pertussis component to the routine tetanus/diphtheria booster currently recommended for adolescents. The committee's favorable recommendation, although not binding, will be considered by the FDA in its final review of the Biologics License Application (BLA) for Boostrix.

Reported cases of pertussis have increased since the mid-1970s. According to the Centers for Disease Control and Prevention (CDC), there were almost 20,000 cases in 2004 -- the highest number of reported cases in more than 40 years. In addition, 39 percent of cases reported to the CDC in 2003 occurred in adolescents 10-19 years of age. Adolescents, in whom classic signs and symptoms of pertussis are often absent, may go undiagnosed and be the source of infection for susceptible infants and other family members.

"Pertussis is a serious and growing public health threat, and we are extremely pleased that the FDA Advisory Committee has provided a unanimous favorable recommendation for FDA approval of Boostrix," said Barbara Howe, M.D., vice president, Clinical Research and Development and Medical Affairs, Vaccines North America, GlaxoSmithKline. "If approved, Boostrix would add a pertussis component to the routine tetanus/diphtheria booster currently administered to adolescents -- a population in which there is a significant disease burden."

Boostrix(TM) [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap)] Clinical Trials
In making its recommendation, the FDA Advisory Committee reviewed several clinical trials which included safety and immunogenicity data from one pivotal trial, which studied Boostrix in more than 3,000 adolescents in the United States, aged 10 to 18. The Phase III clinical trial showed Boostrix to be comparable to a U.S.- licensed Td vaccine [Tetanus and Diphtheria Toxoids] with regard to overall safety and immunogenicity. In addition, the use of Boostrix induced anti-pertussis antibody levels, which were statistically higher than those observed in infants following primary immunization with a DTaP vaccine (Infanrix(R)) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed] in whom efficacy against pertussis disease was demonstrated in a previous study.

In this observer-blinded, randomized, controlled, multi-center clinical trial, 4,114 healthy 10-18-year-olds were vaccinated with one dose of Boostrix or a U.S.-licensed Td vaccine. Each subject had completed his or her routine childhood vaccinations against diphtheria, tetanus and pertussis according to the U.S. recommended schedule. According to study results:

* In both treatment groups, greater than or equal to 99.9 percent of subjects had anti-diphtheria and anti-tetanus concentrations greater than or equal to 0.1 IU/ml, indicating seroprotection against diphtheria and tetanus

* In the Boostrix treatment group, the levels of anti-pertussis antibodies, anti-PT, anti-FHA and anti-PRN were measured and were statistically higher than pertussis antibody concentrations observed in infants, following primary immunization with a DTaP vaccine (Infanrix(R)), in whom efficacy against pertussis disease was previously demonstrated

* The overall safety profile was comparable between the Boostrix and Td groups

"Adolescents are an important reservoir for the disease and often the source of infection for infants," noted Dr. Colin Marchant, adjunct associate professor, Boston University School of Medicine, Boston, MA. "Adding pertussis to the current tetanus and diphtheria booster shot for teens is a logical strategy to prevent this disease in adolescents -- without additional injections -- and may help reduce the risk of transmission to infants in whom pertussis can be deadly."

Source: GlaxoSmithKline

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