FDA approves new pneumonia vaccine with wider reach

February 25, 2010

Prevnar 13 protects against more strains of bacteria than the existing vaccine

and is expected to produce a sharp drop in infections.

By H. Maugh II. February 25, 2010

The Food and Drug Administration on Wednesday 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% of all pneumococcal disease. By 2007, the overall incidence of disease

caused by the seven strains in children younger than 5 had been reduced by 99%.

As the prevalence of the original seven strains of S. pneumoniae was reduced,

however, other strains began moving into their niche. Researchers now think that

as many as three-quarters of new cases of pneumonia and other streptococcal

infections are caused by the six additional strains of bacteria included in the

new vaccine, Prevnar 13, along with the original seven.

The safety of Prevnar 13 was evaluated in 5,084 infants and children; the

control group was an additional 2,760 who received the original Prevnar. The

common adverse reactions were pain, redness and swelling at the injection site,

irritability, fever and decreased appetite -- all common in those who received

the original Prevnar and most other vaccines.

The vaccine is administered in four doses, given at ages 12 to 15 months and 2,

4 and 6 years. The vaccine is available in single-dose, prefilled syringes that

do not contain the controversial preservative thimerosal.

Widespread use of the vaccine will require a recommendation by the Centers for

Disease Control and Prevention's vaccines advisory committee, which met

Wednesday.

The CDC committee recommended using Prevnar 13 to immunize infants and toddlers,

as well as in 5-year-olds with underlying medical conditions. It also

recommended a supplemental dose for children younger than 5 who have completed

the four-dose immunization of the original Prevnar.

In addition, the panel said children who had started their immunization series

with Prevnar should complete the series by switching to Prevnar 13 at any point

in the schedule.

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