On Friday, US Food and Drug Administration (FDA) gave its approval to GlaxoSmithKline's triple vaccine ‘Boostrix’ – which is a combination vaccine for tetanus, diphtheria and pertussis (whooping cough) - for patients aged more than 65 years.
With only individual vaccines currently available in the market to prevent each of the diseases, and multiple vaccines offering protection only against tetanus and diphtheria, the FDA stated that Boostrix is the first vaccine that has been approved to prevent all the three diseases in the senior age group.
Thus far, Boostrix was approved as a booster vaccine for adolescents aged between 10 and 18 years; and for adults aged between 19 and 64 years.
Noting that pertussis is a highly contagious disease, and that outbreaks have been reported among the 65-plus patients in nursing homes and hospitals, Karen Midthun, of the FDA's center for biologics evaluation said: “With this approval, adults 65 and older now have the opportunity to receive a vaccine that prevents pertussis, as well as tetanus and diphtheria.”
To give its approval to Boostrix, the FDA evaluated a study that involved 1,300 patients aged at least 65 years who received Boostrix; and found that the antibody levels of these patients were found to be comparable to those of infants who had been inoculated against pertussis. In addition, their tetanus and diphtheria antibody levels were likewise analogous with those who had received the currently-available licensed vaccines.












