Pfizer’s Prevnar Gains Acceptance

Pfizer’s (PFE - Analyst Report) vaccine segment should strengthen further with the recent approvals in Europe and Canada of Prevnar 13, its 13-valent pneumococcal conjugate vaccine. The vaccine is meant for the prevention of invasive pneumococcal disease (sepsis, meningitis, bacteremia, bacteremic pneumonia, and empyema), pneumonia, and acute otitis media caused by 13 types of streptococcus pneumoniae in infants and children of 6 weeks - 5 years of age. 

The approval of Prevnar 13 was based on data from 13 phase III studies carried out on more than 7,000 children. Earlier, in Sep, Prevnar 13 received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP). Moreover, the vaccine received priority review status from Health Canada earlier this year.

Prevnar 13 is a new version of the currently available pneumococcal vaccine. Prevnar is one of the best selling vaccines worldwide with sales of about $2.7 billion in 2008. While Prevnar treats illness caused by 7 strains of pneumococcal bacteria, the new vaccine is expected to block 13 strains including the original 7. It is estimated that Prevnar 13 would cover 92% of invasive pneumococcal disease, compared to 81% covered by Prevnar. The company is currently seeking approval for Prevnar 13 in about 60 countries spanning six continents and has already been approved in four countries.

Prevnar 13 is yet to receive approval from the US regulators. The vaccine received a positive recommendation from the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee in Nov 2009. The FDA is reviewing the Biologics License Application (BLA) for Prevnar 13, which has an action date of Dec 30, 2009. Though the FDA was initially expected to respond by Sep 30, 2009, the agency had pushed back the approval date by 90 days.

Prevnar 13 is being studied in global phase III clinical trials for the prevention of pneumococcal disease in adults with submissions to regulators expected in 2010. Meanwhile, GlaxoSmithKline (GSK - Analyst Report) received the European approval for its pediatric 10-valent vaccine, Synflorix (meant for children aged 6 weeks to 2 years), in Mar 2009 which will compete with Prevnar and Prevnar 13. However, GlaxoSmithKline does not plan to launch the vaccine in the US.

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