BEIJING, Jan. 26 (Xinhuanet) -- U.S. Federal health advisers said on
Thursday that a five-in-one vaccine for children is both safe and effective.
The endorsement improves the chance the Food and Drug Administration
will give its stamp of approval to the Sanofi Pasteur vaccine, called
Pentacel. The FDA is not required the follow the advice of its outside advisers
but usually does.
The vaccine is meant 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 endorsement came even though several FDA advisers questioned the
efficacy of the Hib component of the vaccine. The panel recommended follow-up
studies on the vaccine if it wins approval.
The vaccine could eliminate seven of the 23 federally recommended
injections children now must endure through age 18 months if approved, 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 first sold in Canada in 1997 and is now available in eight
other countries, the company said.
(Agencies)
