News Feature | October 23, 2014

FDA Accepts Merck's, Sanofi's BLA For Pediatric Hexavalent Vaccine

By Cyndi Root

vaccine

Merck and Sanofi are a step closer to approval of their pediatric hexavalent vaccine, (DTaP5-IPV-Hib-HepB1), as the Food and Drug Administration (FDA) has accepted their Biologics License Application (BLA). The two companies announced the application acceptance in a press release, stating that the pediatric combination vaccine helps protect against six diseases.

John Shiver, Ph.D., SVP of Research and Development at Sanofi Pasteur, said, “Leading organizations – the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians – generally recommend the use of combination vaccines instead of individual injections.”

Pediatric Hexavalent Vaccine

The pediatric hexavalent vaccine is active against diphtheria, tetanus, pertussis (whooping cough), polio (poliovirus types 1, 2, and 3), invasive disease caused by Hemophilus influenza type b (Hib), and hepatitis B. Phase 3 data on the investigational biological treatment was presented at IDWeek in Philadelphia. The study was an active-comparator controlled clinical trial with patients in the U.S. The safety and immunogenicity trial evaluated over 1,400 infants at multiple centers who were administered the hexavalent vaccine or comparator vaccines (Sanofi’s Pentacel plus Merck’s Recombivax HB) at two, four, and six months of age.

Investigators measured antibody levels after administration of the third doses. The results showed that the hexavalent vaccine was non-inferior to the Pentacel/Recombivax in 18 of 19 measures. In measurements of pertussis, the hexavalent vaccine showed slight inferiority. Common adverse events were irritability, crying, and drowsiness. The hexavalent vaccine elicited increased rates of fever, mild to moderate in intensity, two days or fewer in duration. Gary S. Marshall, M.D., lead investigator of the study, said, “This investigational combination vaccine against six important diseases showed similar immune responses against the antigens covered by licensed vaccines.”

Combination Vaccines

Sanofi states that leading institutions recommend combination vaccines over individual vaccines. The Centers for Disease Control (CDC) has issued guidance  stating, “The recommendations in this report are based not only on available scientific evidence but also on expertise that comes directly from a diverse group of health-care providers and public health officials.” The agency says that combination vaccines merge vaccines into a single product and reduce the number of injections patients receive. The CDC lists the advantages of combination vaccines.

  • improved vaccine coverage rates 
  • timely vaccination coverage for children who are behind schedule  
  • reduced shipping and stocking costs
  • reduced costs for extra health-care visits  
  • facilitation of additional new vaccines into vaccination programs

Disadvantages include adverse events such as those that occur with the measles, mumps, rubella, and varicella (MMRV) vaccine, confusion and uncertainty about vaccine combinations, and reduced immunogenicity of one or more components.