NEW YORK -- June 23, 2008 -- The US Food and Drug Administration (FDA) has approved Pentacel vaccine for active immunisation against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b.
Pentacel is approved for use in infants and children aged 6 weeks to 4 years (prior to fifth birthday) and is administered as a 4-dose series at 2, 4, 6, and 15 to 18 months of age. The first dose may be given as early as 6 weeks of age.
"The FDA approval of Pentacel vaccine is great news for parents and paediatricians who want to reduce the stress of well-baby visits," said Tina Q. Tan, MD, Children's Memorial Hospital, Chicago, Illinois.
"Pertussis disease continues to remain a threat to young infants, who are at the highest risk for severe complications and death. With a 4-dose primary series of Pentacel vaccine, paediatricians can reduce the number of vaccination shots while providing protection against 5 diseases, including pertussis."
The FDA approval is based on the results of multicentre clinical studies conducted in the United States and Canada involving more than 5,000 children who received at least 1 dose of the vaccine.
The immunogenicity and safety of Pentacel were compared to separately administered, single-entity, vaccine formulations. Local and systemic reactions following administration of Pentacel were reported at rates consistent with those of the separately administered vaccines used in each trial.
SOURCE: Sanofi Pasteur
E-Mail this DGNews to a colleague
