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FDA approves Pfizer's infant IPD vaccine

The US FDA has approved Pfizer's Prevnar 13, a vaccine for the prevention of invasive pneumococcal disease (IPD) in young children

The US Food and Drug Administration (FDA) has approved Pfizer's Prevnar 13, a vaccine for the prevention of invasive pneumococcal disease (IPD) and otitis media (ear infection) in infants and young children.

Prevnar 13 will be the successor to Prevnar, the blockbuster vaccine licensed by the FDA in 2000, with the new vaccine containing an additional six serotypes of the bacterium Streptococcus pneumoniae to Prevnar's seven. These serotypes are responsible for the majority of remaining IPD in infants and young children in the US.

Pfizer obtained the rights to Prevnar in their acquisition of Wyeth, completed in October 2009.

"We are pleased that the Advisory Committee has recommended the use of Prevnar 13, with coverage for 13 important invasive disease-causing serotypes, in infants and young children in the United States," said Dr Emilio Emini, chief scientific officer, Vaccine Research, Pfizer. "The incidence of disease caused by serotypes not included in Prevnar has been increasing in children younger than five years of age in the United States, including 19A, the most common serotype."

By 2007, the overall rate of IPD caused by Prevnar's original seven serotypes was reduced by 99 per cent. However, of those who were still affected by invasive pneumococcal disease, it was found 62 per cent of cases were caused by the six additional serotypes that will be included in Prevnar 13.

Prevnar 13 was approved after trials involving over 7,000 infants and young children which saw the new vaccine achieve similar levels of safety and effectiveness to its predecessor. 

According to a World Health Organisation (WHO) 2002 estimate, IPD is the leading cause of vaccine-preventable death in children younger than five years worldwide. IPD describes a group of illnesses, all caused by the bacterium Streptococcus pneumoniae and affects infants and young children, leading to invasive infections such as bacteraemia/sepsis and meningitis, as well as non-invasive disease including acute otitis media.

Pfizer expects Prevnar 13 to be introduced commercially in the US in the first quarter of 2010, with approval for the vaccine already granted for infants and young children in 38 other countries.

Prevnar 13 is also being studied in global phase III clinical trials in adults, with regulatory submissions expected later this year.

25th February 2010

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