FDA will Approve the Sanofi Pasteur Vaccine
WASHINGTON - A five-in-one vaccine that might cut the number of jabs children accept is both safe and effective, federal health advisers said Thursday. The endorsement makes it more likely the Food and Drug Administration will approve the Sanofi Pasteur vaccine, called Pentacel. The FDA is not required the follow the advice of its external advisers but regularly does. The vaccine is destined to prevent diphtheria, tetanus, whooping cough, polio and bacterial infection caused by Haemophilus influenzae type b, or Hib. Hib disease can cause meningitis, pneumonia and arthritis.
The approval came even though several FDA advisers questioned the efficacy of the Hib element of the vaccine. The panel recommended follow-up studies on the vaccine if it wins approval.
If approved, the vaccine might eliminate seven of the 23 federally recommended injections kids now must endure through age 18 months, according to Sanofi Pasteur, the vaccines business of Paris-based Sanofi-Aventis. The vaccine would be given in four doses, at 2 months, 4 months and 6 months and finally at 15 months to 18 months.
The vaccine was earliest sold in Canada in 1997 and is now offered in eight other countries, the company said.
AP
The approval came even though several FDA advisers questioned the efficacy of the Hib element of the vaccine. The panel recommended follow-up studies on the vaccine if it wins approval.
If approved, the vaccine might eliminate seven of the 23 federally recommended injections kids now must endure through age 18 months, according to Sanofi Pasteur, the vaccines business of Paris-based Sanofi-Aventis. The vaccine would be given in four doses, at 2 months, 4 months and 6 months and finally at 15 months to 18 months.
The vaccine was earliest sold in Canada in 1997 and is now offered in eight other countries, the company said.
AP
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