US panel backs Sanofi combination vaccine for kids
25 Jan 2007 19:31:17 GMT Source: Reuters
(Adds panel, company comments, background, stock price) By Lisa Richwine BETHESDA, Md., Jan 25 (Reuters) - U.S. advisers backed a Sanofi-Aventis <SASY.PA> <SNY.N> vaccine on Thursday that combines protection against five diseases to reduce the number of shots given to young children. A panel of experts unanimously said the vaccine, named Pentacel, appeared safe and effective. It is designed to prevent diphtheria, pertussis, polio, tetanus and Haemophilus influenzae type b (Hib). Infants and young children are routinely immunized against those and other serious infections. Up to 23 separate injections are given through the first 18 months of life for all of the U.S.-recommended immunizations. Pentacel could reduce the total number of injections by seven, Sanofi said. Another five-disease vaccine, GlaxoSmithKline Plc's <GSK.N> <GSK.L> Pediarix, saves five injections. Pediarix is similar to Pentacel, except that it fights hepatitis B instead of Hib. The Food and Drug Administration will consider the committee's advice before deciding whether to approve U.S. sales of Pentacel. The agency usually clears products that win support from advisory panels. "I think given the risk/benefit ratio of the vaccine overall, the data are sufficient," said Dr. Lisa Jackson, a panel member and senior scientific investigator at Group Health Cooperative in Seattle. Before the panel votes, FDA reviewers questioned if Pentacel provided the same protection as vaccines currently used for pertussis, or whooping cough, and Hib, which can cause meningitis and other serious infections. Some of Sanofi's data showed the pertussis component produced an inferior response to other vaccines, and two studies gave conflicting results for the response to Hib, FDA staff said. Sanofi, however, said data overall provided assurance that the vaccine was effective, as did the experience in Canada, where more than 12 million doses have been administered over nine years. The vaccine has controlled pertussis and Hib infections there, Sanofi officials said. "Pentacel is expected to perform as well in the U.S. as it has in Canada," Dr. David Greenberg, scientific and medical affairs director for Sanofi vaccine unit Sanofi Pasteur, told the panel. Some panel members said they were concerned about the Hib results but not enough to vote against the vaccine. "I'm willing to vote yes on these, but I think this is going to have to be sorted out in the follow-up (to) see what happens once this vaccine is used," said panel member Dr. Philip LaRussa, a Columbia University pediatrician. Pentacel already is sold in nine countries including Canada. The vaccine can be given along with other childhood immunizations. Pentacel's recommended dosing is a four-shot series at two months of age, four months, six months and between 15 and 18 months. In Sanofi's studies, reactions such as redness and swelling occurred at similar rates with Pentacel compared to other vaccines on the market, FDA reviewers said. Shares of Paris-based Sanofi were down 51 cents at $45.70 in afternoon trading on the New York Stock Exchange.
