- The CDC Reinstates Booster Dose of Hib Vaccine -

SWIFTWATER, Pa., June 25 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that the company has been able to increase the supply of its Hib-containing vaccines to enable the return to a full series of vaccinations for U.S. children. Based on the increased supply, on July 1, the U.S. Centers for Disease Control and Prevention (CDC) will reinstate its recommendation that children receive a booster dose of Haemophilus influenzae type b (Hib) vaccine after 12 months of age. The CDC also provided guidance on a phased approach to immunize children whose booster dose was previously deferred at their next regularly scheduled medical visit. The CDC had recommended a temporary deferral of the booster dose of Hib vaccine in 2007 due to supply constraints caused by another manufacturer's withdrawal of Hib vaccine from the market. Since that time, Sanofi Pasteur has been, and continues to be, the sole supplier of Hib vaccine to the U.S. market.

Sanofi Pasteur is able to meet the nation's need for Hib vaccination through the use of its two Hib-containing vaccines: Pentacel(R) (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate [Tetanus Toxoid Conjugate] Vaccine) and ActHIB(R) (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]).

'Sanofi Pasteur has accelerated production and reallocated excess global supplies so that health-care providers can stop deferring the booster dose and return to protecting children with the full Hib vaccine series,' said Wayne Pisano, president and CEO of Sanofi Pasteur. 'We are proud that we are able to fulfill this important national need. In recent years, Sanofi Pasteur has supplied approximately half the Hib vaccine in the U.S. each year, but we have been able to substantially increase supply in 2009 to help make up for the shortfall created by the other manufacturer's continued absence.'

'The reinstatement of the booster dose of Hib vaccine is important due to recent epidemiologic trends,' said Dr. Gary Overturf, professor of pediatrics and pathology at the University of New Mexico. 'The deferral of the booster dose was always meant to be a temporary situation, but now that nearly 18 months have passed, we have seen several cases of Hib disease primarily among unimmunized and partially immunized children. This could represent an increase of Hib carriage and transmission from older non-symptomatic children to those children whose parents refused vaccination or are too young to have received their full primary series. While this is a hypothesis, it's reassuring to know we won't have to put it to the test, and can begin immunizing with the full schedule again.'

The CDC recommends that children receive a primary series of Hib vaccinations during infancy and a booster dose at 12-15 months of age. Sanofi Pasteur has been working closely with the CDC since December of 2007 to meet the country's Hib immunization needs, and maximize the availability of the vaccine to the greatest number of children. As is the case with many vaccines, Hib vaccine manufacturing is a complex biological process with lengthy production cycles.

To maintain adequate supplies of Hib vaccine throughout the reinstatement period, the CDC is encouraging all health-care providers to administer the booster dose of Hib vaccine to children older than 12 months of age who were previously deferred, at the next regularly-scheduled medical encounter.