USA licenses and recommends new 13-valent pneumococcal conjugate vaccine

Today, the USA added 13-valent pneumococcal conjugate vaccine to its routine immunization program for infants and young children. In what CDC Director, Tom Frieden, referred to as a "just in time" policy handoff from one agency to another the US Food & Drug Administration issued news of its licensure of the new vaccine just one half-hour before the CDC's Advisory Committee for Immunization Practice sat down to discuss and vote on its recommendations.

The vaccine, manufactured by Pfizer Inc., contains 13 important serotypes and will be known as Prevnar 13. Since 2000, the United States has routinely immunized infants and children with a 7-valent pneumococcal conjugate vaccine. The new recommendation indicates that the new vaccine should replace the 7-valent vaccine for healthy children aged 2 months through 59 months and provides guidance for vaccinating older children with high-risk conditions. Find additional highlights of the recommendations here.

The licensure decision was widely expected for some time. The FDA's Advisory Panel had recommended licensure in November 2009, and the vaccine has been licensed or registered for use in more than 40 countries since its first licensure in Chile in July 2009. In the United States, the price of the vaccine will be about $100 per dose, according to the company.

Both Prevnar 13™ from Pfizer and GlaxoSmithKline's 10-valent pneumococcal conjugate vaccine, Synflorix™, are expected to be made available to developing countries this year through the Advanced Market Commitment at steeply discounted prices for GAVI eligible countries. For more information on the Advance Market Commitment, please visit www.vaccineamc.org. For more information on pneumococcal vaccines, please visit the pneumoACTION website at www.preventpneumo.org.