Pfizer wins Prevenar 13 expansion in EU
Pfizer ($PFE) has always harbored substantial goals for its pneumococcal conjugate vaccine, and the pharma giant got a leg up Tuesday when the European Commission approved the use of Prevenar 13 in older children and adolescents.
Healthcare providers may now administer the jab, which protects against sometimes fatal illness caused by the bacterium Streptococcus pneumoniae, to people ages 6 to 17. That's good news for a vaccine already approved in 120 countries for use in infants and young children. Analysts, on average, forecast Prevenar 13 to reach $4.42 billion at the end of 2012, and they expect that to increase to $6.75 billion by 2016. Prevenar 13, or Prevnar 13 as it's called in the United States, Canada and Taiwan, is also approved for adults 50 years of age and older in more than 70 countries.
The commission gave the go-ahead after reviewing a Phase III trial of Prevenar 13 in 592 healthy children and adolescents, including those with underlying medical conditions such as asthma.
"Children and adolescents aged 6 to 17 with underlying medical conditions have an increased risk of pneumococcal disease," said Luis Jodar, vice president of Pfizer's Vaccines Global Medicines Development Group. "Pfizer will continue working with health authorities worldwide in an effort to provide access to Prevenar 13 to those at risk of disease."
The approval rides on the tails of an OK from the World Health Organization last fall to use the shot in adults over the age of 50. Pfizer said it would increase its manufacturing capacity for the vaccine and invest in a multidose vial that, if approved, would help out in developing countries. The vaccine is available for pediatric use in 16 of the 18 countries that have launched national immunization programs with a pneumococcal conjugate vaccine through the Advance Market Commitment program.
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