A new vaccine, which is expected to be able to eliminate six of the 20 injections that babies receive before age two years, has received federal approval. Pediarix™ (GlaxoSmithKline) combines protection, into one injection, against five serious diseases—diphtheria, tetanus, whooping cough (pertussis), hepatitis B, and polio.
The vaccine is to be given in a three-dose series to infants at two, four, and six months of age.
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Until now, children needed nine shots to protect them; with the new vaccine, they need only three. This approval represents a major breakthrough and should greatly reduce anxiety for both children and their parents.
A new vaccine offers a single booster immunization against pertussis (whooping cough), in combination with tetanus and diphtheria, for adolescents and adults 11 to 64 years of age. The vaccine will be marketed as Adacel™ by Aventis Pasteur, Ltd., in Toronto, Canada.
This is the first vaccine approved as a pertussis booster for adults. Vaccines for the prevention of tetanus and diphtheria (Td vaccine) in adolescents and adults have been available for many years. The product is a tetanus toxoid (T), reduced diphtheria toxoid (d) and acellular pertussis vaccine (ap), adsorbed. It contains the same components as Daptacel® (Aventis Pasteur), a DTaP vaccine for infants and children, but the diphtheria toxoid and one of the pertussis components are in reduced quantities.
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The FDA recently approved a similar vaccine, Boostrix™ (GlaxoSmithKline), for adolescents.
The FDA has approved an influenza vaccine (FluLaval, GlaxoSmithKline) for the active immunization of patients 18 years of age and older against influenza virus subtypes A and B. This approval is a major step toward increasing the influenza vaccine supply in the U.S., following the introduction of GSK’s Fluarix before last year’s flu season.
The company added FluLaval to its portfolio of flu products when it acquired the Canadian vaccine manufacturer ID Biomedical Corporation in 2005. Flu-Laval was granted fast-track review status by the FDA in July 2005. It is marketed under the name Fluviral in Canada.
FluLaval contains noninfectious killed viruses, and it cannot cause influenza. It will be available in 10-dose multidose vials. It is not indicated for use in children or for anyone with known systemic hypersensitivity reactions to egg proteins (in eggs or egg products), chicken proteins, or any component of FluLaval.
The FDA has approved the first vaccine in the U.S. for humans against the H5N1 influenza virus, commonly known as avian flu or bird flu. The vaccine, made by Sanofi-Pasteur, could be used if the current H5N1 avian virus were to develop the capability to spread among humans. If such an influenza pandemic emerges, the vaccine may provide early limited protection in the months before a vaccine tailored to the pandemic strain of the virus …