pentacel :: Article CreatorSanofi's Pentacel To Compete With GSK's Five-in-one Jab In USA
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 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".
Pentacel Pediatric Vaccine Approved - MPR
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U.S. FDA Licenses Sanofi Pasteur's New Pediatric Combination Vaccine ...
Pentacel(R) vaccine is approved for administration as a four-dose seriesat 2, 4, 6 and 15-18 months of age. The first dose may be given as early as 6weeks of age. According to the current Recommended Childhood ImmunizationSchedule of the U.S. Centers for Disease Control and Prevention (CDC), up to23 injections are needed by the time a child reaches 18 months of age withsingle-entity vaccines. The use of Pentacel(R) vaccine could reduce thatnumber of shots by seven.
"Pentacel(R) vaccine will help simplify the immunization schedule byreducing the number of injections infants and young children will receive intheir first two years of life," said Wayne Pisano, President and ChiefExecutive Officer, sanofi pasteur. Pentacel(R) vaccine has been used in Canadafor a decade and is licensed in seven other countries. "We are pleased thatthe U.S. FDA has now taken this important step, to make the convenience ofPentacel(R) vaccine available to health-care providers and parents in theU.S.," Pisano added.
"The FDA approval of Pentacel(R) vaccine is great news for parents andpediatricians who want to reduce the stress of well-baby visits," said Tina Q.Tan, M.D., infectious disease specialist, Children's Memorial Hospital,Chicago. "Pertussis disease continues to remain a threat to young infants, whoare at the highest risk for severe complications and death. With a four-doseprimary series of Pentacel(R) vaccine, pediatricians can reduce the number ofvaccination shots while providing protection against five diseases, includingpertussis."
Pentacel(R) vaccine is also the first five-component (pentavalent)pediatric combination vaccine in the U.S. To contain sanofi pasteur's fiveacellular pertussis antigens, which are also used in its DTaP vaccine forchildren (DAPTACEL(R)(a) vaccine, licensed in 2002) and its tetanus,diphtheria, and acellular pertussis (Tdap) vaccine for adults and adolescents(Adacel(R)(b) vaccine, licensed in 2005). Pertussis is commonly known aswhooping cough because of the sound some patients -- especially children --make while gasping for air during coughing spells.
The FDA licensure of Pentacel(R) vaccine is based on the results ofmulti-center clinical studies conducted in the U.S. And Canada involving morethan 5,000 children who received at least one dose of Pentacel(R) vaccine. Theimmunogenicity of Pentacel(R) vaccine was compared to separately administeredDAPTACEL, IPOL(R)(c) and ActHIB(R)(d) vaccines (studies P3T06 and M5A10), aswell as to other single-entity vaccine formulations (study 494-01). The safetyof Pentacel(R) vaccine was compared both to separately administered DAPTACEL,IPOL and ActHIB vaccines (study P3T06) and to other single-entity vaccineformulations (study 494-01).
In clinical studies, local and systemic reactions following administrationof Pentacel(R) vaccine were reported at rates consistent with those of theseparately administered vaccines used in each trial. The most common local andsystemic adverse reactions to Pentacel(R) vaccine incl
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