FDA OKs Updated Infection Vaccine for Children

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Pfizer said Wednesday the Food and Drug Administration has approved an updated version of its best-selling infection vaccine for infants and children.

Prevnar 13 is intended to reduce the risk of infection by 13 strains of pneumococcal disease in children 5 years old and younger. The disease causes ear infections, meningitis and pneumonia.

Prevnar 13 adds protection against six additional strains of bacterial infection compared with the current vaccine. But that extra benefit comes with a price.

The new vaccine will cost $108 per dose, up 35 percent from $80. With four injections needed to complete the vaccine dosing, uninsured families would have to pay $432 out of pocket for Prevnar 13.

Government health providers will pay $100 a dose for the new vaccine, up from $65 per dose for original Prevnar.

Prevnar 13, developed by Wyeth, is the first product to win FDA approval since Pfizer acquired that company last year.

With sales of $2.7 billion in 2008, Prevnar was the world's top-selling vaccine in 2008 and was considered a key product in Pfizer's decision to purchase Wyeth for $68 billion.

The FDA was scheduled to make a decision on Prevnar by last September, but extended its review twice since then.

Infections from pneumococcal disease dropped dramatically after the original Prevnar was released in 2000. However, infections began rising again in 2005 with the development of new variants of the disease.

Dr. Emilio Emini, Pfizer's chief of vaccine research, said the six new strains of pneumococcal disease covered by the vaccine account for 70 to 75 percent of new infections in the U.S. When combined with the seven types covered by the original vaccine, Emini says Prevnar 13 covers 90 to 95 percent of the causes of the disease in the U.S.

The vaccine also protects against two varieties of pneumococcal disease that account for most cases in the developing world.

The World Health Organization has called the disease the top vaccine-preventable cause of death in the world.

The vaccine requires a series of four injections, generally given at 2, 4 and 6 months old and then between 12 and 15 months old.

To assure wide scale use in the U.S., Prevnar 13 will need the recommendation of the Centers for Disease Control, which issues guidelines on vaccines to doctors and hospitals. About an hour after the Pfizer announcement, a CDC advisory panel on immunizations — meeting in Atlanta — voted to recommend that doctors start using Prevnar 13 to replace the older Prevnar vaccine.

The company has already prepared 8.3 million doses and expects to start shipping them in mid-March, said Matt Garrett, a Pfizer vice president at the CDC meeting.

Leerink Swann analyst Seamus Fernandez expects combined revenue of $1.5 billion for Prevnar 13 and regular Prevnar this year.

Pfizer Inc. shares rose 93 cents to $17.83 in afternoon trading.