Pfizer's Prevenar 13 gains expanded EU approval to include adults aged 18 to 49 years

The European Commission expanded approval of Pfizer's Prevenar 13 (pneumococcal 13-valent conjugate vaccine) to include adults aged 18 to 49 years for active immunisation for the prevention of invasive disease caused by Streptococcus pneumonia, the company reported Wednesday. Luis Jodar, vice president of the company's Vaccines Global Medicines Development Group, said those "with certain underlying medical conditions may benefit in particular from vaccination with Prevenar 13 because of an increased risk of pneumococcal disease."

The drugmaker noted that the EU regulator is the first to approve Prevenar 13 to offer protection against invasive disease at all stages of life. Previously the vaccine was cleared for use in infants, young children and adolescents aged 6 weeks to 17 years, as well as adults 50 years of age and older. The latest approval was supported by results of a Phase III trial showing that Prevenar 13 is at least as immunogenic in healthy adults aged 18 to 49 years as it is in adults 60 to 64 years of age, as measured one month after vaccination.

The vaccine, which is known as Prevnar 13 in certain markets including the US, is approved in more than 120 countries worldwide for use in infants and young children, and in more than 80 countries for use in adults 50 years of age and older. In January, the FDA broadened the approval for Prevnar 13 to prevent infections caused by the pneumococcal bacteria in children and adolescents aged 6 years to 17 years. The product recorded revenue of $846 million in the first quarter, with Pfizer expecting sales to strengthen during the year as wholesalers use up existing supplies.

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