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Pfizer wins green light for pneumococcal vaccine Prevnar 13 in over-50s

US licence for pneumococcal conjugate vaccine extended

Pfizer's pneumococcal conjugate vaccine Prevnar 13 has been approved in the US for use in people aged over 50, extending its indications from the current use in children from six months to five years.

Prevnar 13 is the first pneumococcal vaccine to be cleared by the FDA in this age group and addresses "a leading public health issue", according to the company, which notes that pneumococcal disease is on the rise in the over-50s.

The vaccine has been given the go-head as a single dose for preventing pneumonia and invasive disease caused by 13 strains of Streptococcus pneumoniae. This use has already been approved in the EU, Australia, Mexico and more than 10 other countries around the world.

There are estimated to be hundreds of thousands of S. pneumoniae infections per year, including more than 440,000 cases of pneumococcal pneumonia, accounting for an estimated 200,000 emergency department visits and 300,000 hospitalisations, according to Pfizer.

"Pneumococcal disease, including pneumonia, in adults 50 years and older represents a significant personal and societal health burden in the US," said Pfizer's chief executive Ian Read.

Last November, an FDA advisory committee voted in favour of approval of Prevnar 13 in the over-50s after concluding that based on immune response data it was at least as effective in this patient population as Merck & Co's older pneumococcal polysaccharide vaccine Pneumovax.

The vaccine was granted accelerated approval in the US on the strength of that data, with the condition that Pfizer conduct a prospective study to test whether Prevnar 13 can prevent community-acquired pneumonia in adults.

The company says it is already enrolling patients into an 84,000-strong study called CAPiTA to fulfil that requirement, and is also carrying out a second trial to test the efficacy of Prevnar 13 when given after exposure to Pneumovax.

Prevnar 13 has become one of Pfizer's fastest-growing products since its launch in February 2010, topping the $1bn sales barrier in the third quarter of last year.

3rd January 2012

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