FDA approves new pneumonia vaccine

LOS ANGELES - The Food and Drug Administration yesterday approved a new pneumococcal vaccine that protects against more strains of bacteria than the existing one and is expected to produce a sharp reduction in the number of cases of bacterial pneumonia and ear infections in children and adolescents.

The existing vaccine, called Prevnar, protects against the seven main strains of Streptococcus pneumoniae, which not only produce pneumonia, but also can invade the blood, middle ear and the covering of the brain and spinal cord.

When Prevnar was first marketed in 2000, those seven strains accounted for about 80 percent of all pneumococcal disease. By 2007, the overall incidence of disease caused by the seven strains in children under age 5 had been reduced by 99 percent.

As the prevalence of the original seven strains of S. pneumoniae was reduced, however, other strains began moving into their niche.

Researchers now believe that as many as three-quarters of new cases of pneumonia and other streptococcal infections are caused by the six additional strains of bacteria that are included in the new vaccine, Prevnar 13, along with the original seven.

The safety of Prevnar 13 was evaluated in 5,084 infants and young children who received it. The common adverse reactions were pain, redness and swelling at the injection site, irritability, decreased appetite and fever - all common in those who received the original Prevnar.

The vaccine is administered in four doses, given at 2, 4, 6 and 12 to 15 months of age.

Widespread use of the vaccine will require a recommendation by the Centers for Disease Control and Prevention's vaccines advisory committee.