The US Food and Drug Administration has accepted Sanofi Pasteur’s Biologics Licensing Application for Pentacel, a pediatric combination vaccine candidate offering protection against diphtheria, tetanus, pertussis, polio and Haemophilus influenza type B.
Sanofi Pasteur, the vaccines unit of French drug major Sanofi-Aventis, says that Pentacel is the first diphtheria, tetanus and pertussis-based combination vaccine candidate for use in infants in the USA that includes both polio and Hib vaccine components.
In the USA, up to five separate vaccine injections may be required during well-child visits, according to the current Recommended Childhood and Adolescent Immunization Schedule from the Advisory Committee on Immunization Practices of the US Centers for Disease Control and Prevention. If approved, Pentacel, which is already cleared for paediatric use in nine countries, could reduce that number by two, thereby providing a significant advantage over its competitors.
“Pentacel vaccine could be easily integrated into the recommended childhood vaccination schedule," noted Steven Black, MD, co-director of the Kaiser Permanente Pediatric Vaccine Study Center. "In addition, this combination vaccine has the potential to protect against five diseases in a single injection."
Meantime, Sanofi Pasteur MSD, a joint venture between Sanofi-Aventis and Merck & Co in Europe, says that its Inactivated Influenza Vaccine (Split Virion) is now available as a 0.25mL formulation for the first time, specifically for infants aged six-35 months. The vaccine comes as a pre-filled syringe and will eradicate the need for healthcare professionals to estimate the dose from the 0.5mL presentation marketed for older children and adults.
According to the firm, recent market research revealed that 98% of a group of practice nurses prefer use of the 0.25mL form for the youngest age group, but that a significant amount expressed concern over the difficulty in estimating this dose from the 0.5mL version.
Commenting on the new formulation, specialist Primary Care Nurse Sara Richards said: “The new 0.25Ml flu vaccine presentation, specifically for young children, will not only save Practice Nurses time, but will also give them peace of mind that they are giving exactly the dose they want to use.”