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UPDATE: Sanofi To Fill US Vaccine Supply Gap Caused By Merck -- By Peter Loftus -- U.S. children can resume getting booster shots of a meningitis vaccine beginning in July, ending an 18-month suspension of such shots due to a Merck & Co. Inc. (MRK) manufacturing shortage. The U.S. Centers for Disease Control and Prevention said Thursday it's reinstating the booster shots for children ages 12 to 15 months because supplies of Sanofi-Aventis SA's (SNY) meningitis vaccine products will increase beginning in July. |
June 25, 2009 |
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U.S. children can resume getting booster shots of a meningitis vaccine beginning in July, ending an 18-month suspension of such shots due to a Merck & Co. Inc. (MRK) manufacturing shortage.
The U.S. Centers for Disease Control and Prevention said Thursday it's reinstating the booster shots for children ages 12 to 15 months because supplies of Sanofi-Aventis SA's (SNY) meningitis vaccine products will increase beginning in July.
"In recent years, Sanofi Pasteur has supplied approximately half the Hib vaccine in the U.S. each year, but we have been able to substantially increase supply in 2009 to help make up for the shortfall created by the other manufacturer's continued absence," Wayne Pisano, head of Sanofi's vaccine unit, said in a press release.
Merck, which suspended production of its meningitis vaccine in December 2007 due to potential contamination issues, is now working with regulatory authorities to try to make limited supplies of its meningitis vaccine available by the end of the year, a Merck spokeswoman said. The Whitehouse Station, N.J., pharmaceutical company expects it to be fully available in early 2010. The vaccine previously accounted for a relatively small portion of Merck's overall sales.
The so-called "Hib" vaccine is designed to protect against a bacteria that causes meningitis, an infection of the protective lining around the brain and spinal cord. The vaccine is typically given in two or three doses in the first year of life, followed by a booster shot for kids ages 12 to 15 months.
In December 2007, Merck recalled certain lots of two products containing the Hib vaccine, PedvaxHIB and Comvax, because of potential contamination. The subsequent production suspension caused a shortage because Sanofi wasn't immediately able to step up production of its Hib-vaccine products.
Merck later received a warning letter from the U.S. Food and Drug Administration because agency investigators found violations of manufacturing rules during inspections of Merck's vaccine-production plant in West Point, Pa., during inspections between November 2007 and January 2008.
Merck has said it resolved problems with equipment sterilization, but has identified other issues that require a regulatory filing, which has delayed its return to the U.S. Hib vaccine market.
During the shortage, children continued to get the initial doses but the CDC recommended the 12-to-15-month booster shots be deferred. High-risk children such as those with immune-system problems continued to get the booster shots. Children who didn't receive the booster shot during the shortage will now be able to get it at their next routinely scheduled doctor's office visit. Continuing supply constraints won't allow a mass recall of older children to immediately get booster shots that were deferred, the CDC said.
The Sanofi products containing Hib vaccines are called ActHIB and Pentacel.
The CDC said the suspension of the booster shot, combined with a possible decrease in initial dosing, may have contributed to increased Hib transmission and related diseases in the U.S. Merck shares rose $1.02, or 4%, to $26.47, while Sanofi's American depositary shares fell $1.60, or 5%, to $30.24.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com
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