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Pfizer's Prevnar 13 pneumococcal vaccine effective in older children

US pharma firm says data will support regulatory submissions for expanding product's labelling

Pfizer's vaccine to prevent pneumococcal diseases Prevnar 13 is both safe and effective in preventing disease in children aged five to 17, according to a new study.

The company says the data, which is being presented at the eighth International Symposium on Pneumococci and Pneumococcal Diseases in Brazil, paves the way for expansion of the vaccine's label in the US, EU and other countries, with regulatory submissions already planned.

Currently, Prevnar 13 is approved in the US for use in children six weeks through five years for prevention of invasive disease and ear infections, as well as adults over 50 based on their immune response to the vaccine.

In Europe, where the drug is known as Prevenar 13, it is approved for use in children aged six weeks to five years and for the prevention of invasive disease caused by Streptococcus pneumoniae, in adults aged 50 years and older.

An extra indication is expected to boost sales of the drug, which is already among Pfizer's biggest sellers with revenues of $3.7bn during 2011.

Dr Emilio Emini, chief scientific officer, vaccine research, Pfizer, said: “We are excited about the potential to further define the clinical utility of Prevnar 13 with the aim of seeking to broaden prevention efforts to additional age groups.”

The phase III trial involved 598 healthy children, including children aged 5 to 10 years who had previously been vaccinated  with Prevnar, the original version of the vaccine, and  children and adolescents aged 10 through 17 years who had not received any vaccine.

It assessed the pneumococcal immune responses induced by Prevnar 13 when measured one month after vaccination in each of the age groups, with safety of the vaccine measured by the incidence rates of local reactions, systemic events, and adverse events.

13th March 2012

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