Prevnar 13: Additional Phase III data

Additional data from 900 healthy adults aged 18-49 in the open-label portion of the Phase III Study 004 trial showed that Prevnar 13 produced immune responses for all 13 serotypes contained in the vaccine that were non-inferior to the immune response produced in patients aged 60-64 in the double-blind portion of the trial. Pfizer said the data were included in a regulatory submission in the EU seeking to expand the label of Prevnar 13 to include use in adults aged 18-49. The trial comprised a double-blind portion in 740 adults ages 60-64 and 2 open-label portions in 370 adults aged 50-59 and 900 adults aged 18-49, respectively. In 2011, Pfizer reported data from 835 healthy pneumococcal vaccine-naïve adults aged 60-64 enrolled in the trial showing that Prevnar 13 met the primary endpoint by demonstrating non-inferior immunogenicity compared to Pneumovax 23 pneumococcal vaccine for the 12 serotypes common to both vaccines. Pfizer also said the vaccine was as immunogenic in the 50-59 age group compared to the older group for all serotypes (see BioCentury, May 16, 2011).

In September, the World Health Organization (WHO) granted an expansion of the prequalification of Prevnar 13 to include use in adults >=50 years of age to prevent pneumonia and invasive disease caused by the 13 serotypes contained in the vaccine (see BioCentury, Sept. 17). Last year, FDA granted accelerated approval to Prevnar 13 to prevent pneumococcal disease in adults >=50 years. The European Commission also expanded the vaccine's label to include the indication (see BioCentury, Oct. 31, 2011 & Jan. 2, 2012). The vaccine is approved in infants and children ages 6 weeks through 5 years in the U.S. and EU, where it is known as Prevenar 13. ...