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Oct 27, 2011

EC Clears Pfizer’s Pneumococcal Vaccine for Use in Individuals Over Age 50

  • The European Commission granted Pfizer’s 13-valent pneumococcal conjugate vaccine Prevenar 13 extended approval for use in the prevention of invasive pneumococcal disease caused by Streptococcus pneumoniae, in adults aged 50 years and over. Clearance of the vaccine for use in the new age group followed the regulator’s review of Prevenar 13 clinical safety and immunogenicity data in over 6,000 adults aged at least 50 years.

    The latest approval covers the use of a single dose of Prevenar 13 for preventing invasive pneumococcal disease caused by 13 serotypes covered by the vaccine, regardless of prior pneumococcal vaccination status. Prevenar 13 should also be given first if use of a 23-valent polysacchraride vaccine is also considered appropriate.

    Prevenar 13 (Prevnar 13 in the U.S.) was first introduced in 2009 in Europe, for use in infants and young children. Pfizer says the vaccine is now available for this indication in over 100 countries. The firm reported global sales of the vaccine reached $821 million in the second quarter of 2010 (three months to June 31), up 44% on Q2 2010 revenues. Prevenar 13/Prevnar 13 revenues were $1,817 for the first six months of 2011, up 113% on the $855 million in revenues recorded for the same period in 2010.

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