GlaxoSmithKline's application for DTaP-IPV vaccine is accepted for review by the FDA

New vaccine could be the first and only DTaP-IPV combination vaccine indicated for four through six year olds in the U.S.

PHILADELPHIA, PA, USA | June 13, 2007 |
GlaxoSmithKline (NYSE:GSK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for a DTaP-IPV combination vaccine (diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine combined). GlaxoSmithKline is seeking U.S. approval for the new DTaP-IPV pediatric booster vaccine for immunization against diphtheria, tetanus, whooping cough (pertussis), and polio diseases in children 4 through 6 years of age.

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) recommend that children receive booster shots to protect against diphtheria, tetanus, pertussis, and polio at the 4 to 6 year-old doctor’s visit. When following the recommended schedule, by age six a child should have received five doses of the Diphtheria-Tetanus-acellular Pertussis (DTaP) vaccine and four doses of the inactivated poliovirus (IPV) vaccine. Currently the 4 to 6 year-old DTaP and IPV vaccinations are given as two separately administered shots. If approved, this DTaP-IPV combination vaccine could streamline the current recommended immunization schedule and deliver overall protection with one less shot.

ACIP, AAP and AAFP have stated a preference for the use of licensed combination vaccines over separate injection of the equivalent component vaccines as a practical way to overcome the constraints of multiple injections and as a possible way to improve timely vaccination coverage.

“If approved, our combination DTaP-IPV vaccine could decrease the number of shots needed to provide all recommended immunizations for children 4 to 6 years of age, making it easier for them to receive their vaccines on time,” said Barbara Howe, M.D., Vice President, North American Vaccine Development, GlaxoSmithKline.“This investigational combination vaccine highlights GSK’s focus on increasing vaccine coverage and on-time immunization rates for young children through our innovative vaccine pipeline.”

About DTaP-IPV
DTaP-IPV is a combination vaccine that is under development by GlaxoSmithKline. If licensed, it will be the first and only DTaP-IPV combination vaccine in the U.S. indicated for immunization against diphtheria, tetanus, pertussis, and polio diseases for use at the 4 to 6 year-old doctor’s visit as the fifth dose in the CDC-recommended DTaP series and the fourth dose in the CDC-recommended IPV series.

A U.S. phase III clinical study was presented at the Pediatric Academic Societies’ Annual Meeting in Toronto, Canada, on May 7, 2007. The study evaluated the immune response and safety profile of the investigational combination DTaP-IPV vaccine in children ages 4 to 6 years old as compared to separately administered DTaP and IPV vaccines, when co-administered with measles, mumps and rubella (MMR) vaccine (M-M-RII®) at a separate site. Study results showed that children receiving the combination vaccine demonstrated an overall comparable immunogenicity and safety profile to children receiving the separately administered component vaccines.

About Pertussis, Tetanus, Diphtheria, and Polio
Pertussis (whooping cough), tetanus and diphtheria are all serious, potentially fatal diseases caused by bacteria. Whooping cough spreads easily through the air and can cause severe coughing fits, vomiting, pneumonia, and death. Infants who have not been fully vaccinated are thought to be at the highest risk for developing pertussis and its complications, including death.

Tetanus (lock jaw) can cause muscle stiffness and spasms, often starting in the muscles of the jaw and neck. Severe tetanus can lead to death. Tetanus enters the body through cuts or wounds in the skin.

Diphtheria typically affects the tonsils and the throat and causes a thick covering in the back of the throat. It is usually spread from person to person when an infected person coughs or sneezes. It can lead to breathing problems, paralysis, heart failure and even death.

Polio is a viral disease that enters a person’s body through the mouth. Sometimes it does not cause serious illness. However, it may cause paralysis of the arms and legs and can lead to death in infected people by paralyzing the muscles that help them breathe.

GlaxoSmithKline: A Leader in Vaccines
GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, NC, is one of the world’s leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

GSK Biologicals (GSK Bio), one of the world’s leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline’s activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world — an average of three million doses a day. Of those vaccine doses, approximately 136 million were doses of combination pediatric vaccines which help protect the world’s children, from up to six diseases in one vaccine.


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