The vaccines unit of Sanofi-Aventis says that US regulators have given the green light to the firm’s new five-in-one paediatric jab Pentacel.
The US Food and Drug Administration has approved Sanofi Pasteur’s Pentacel which offers protection against diphtheria, tetanus, pertussis, polio and Haemophilus influenza type B. Specifically, Pentacel has been approved for administration as a four-dose series at 2, 4, 6 and 15-18 months of age.
Pentacel is the only four-dose diphtheria, tetanus and acellular pertussis (DTaP)-based combination vaccine for use in youngsters in the USA that includes both poliovirus and Hib antigens. The first dose may be given as early as six weeks of age and Sanofi noted that according to the current immunisation rules in the USA, up to 23 injections are needed by the time a child reaches 18 months with single-entity vaccines. The use of Pentacel can reduce that number of shots by seven.
The vaccine will “help simplify the immunisation schedule by reducing the number of injections infants and young children will receive in their first two years of life,” said Sanofi Pasteur chief executive Wayne Pisano. The firm noted that Pentacel has been used in Canada for a decade and is licensed in seven other countries.
It has taken a far bit longer to get approval in the USA. A Biologics Licensing Application for Pentacel was submitted in September 2005 and an FDA decision on that file was delayed from June last year to November 2007 as the agency cited technical issues connected with the vaccine.
The go-ahead in the USA should transform sales of the jab and will put Pentacel up against GlaxoSmithKline’s five-in-one shot Pediarix, though the latter includes hepatitis B vaccine in place of Hib. Analysts at Natixis Securities have issued a note saying that “even if Sanofi is a bit behind Glaxo in this area, the approval of Pentacel should add 300 to 400 million euros to sales”.
