Pfizer received approval from the U.S. Food and Drug Administration on Friday to use Prevnar 13 in children and adolescents between the age of 6 and 17 to prevent Invasive Pneumococcal Disease.
Prevnar 13 becomes the first and just the only Pneumococcal Conjugate Vaccine that has been approved for this particular age group. Pfizer announced the FDA’s approval for expanded use of the vaccine in a Friday press release. In this age group, the vaccine will be administered via a one-time only dose to those who have not received Prevnar 13 previously.
Pfizer said its extension of the use of Prevnar 13 to adolescents and older children between the ages of 6 and 17 reflects the company’s dedication to improving public health across the globe.
The approval from the FDA came after the regulatory agency reviewed a trial of 592 adolescents and older children who were given Prevnar 13. The study established a safety profile in the age group consistent with ones established in trials previously held in young children and infants.
The vaccine was first used in young children and infants in Europe in December of 2009 in the U.S. in February of 2010. It is presently approved for that use in over 120 countries. The vaccine is also part of regional and national immunization programs in over 60 countries.
Prevnar 13 was also approved previously to be used in people who are 50 or older in over 80 countries worldwide. It also is the first and just the only pneumococcal vaccine that has been given prequalification for the adult population by the World Health Organization.
Get Analysts' Upgrades and Downgrades Daily - Enter your email address below to receive a concise daily summary of analysts' upgrades, downgrades and new coverage with MarketBeat.com's FREE daily email newsletter.