Booster Shot Production of Meningitis Vaccine Increased by Sanofi
Booster Shot Production of Meningitis Vaccine Increased by Sanofi

The booster shot of meningitis vaccine for children is set to resume beginning in July due to increased production by vaccine maker Sanofi-Pasteur. This will end the 18 month suspension of these shots which was put in place due to a Merck & Co. Inc. manufacturing shortage.

The vaccine is typically given in two or three doses to infants and children between the ages of 2 to 18 months as prevention against invasive Hib disease, followed by a booster shot for kid’s ages 12 to 15 months.

The U.S. Centers for Disease Control and Prevention had suspended its recommendation that children receive a booster dose of Haemophilus influenzae type b (Hib) vaccine after 12 months of age in 2007 due to shortage of the vaccine.

On Thursday the CDC said it was reinstating the suspended booster shots as the vaccine supply would increase in July.   In a press release Wayne Pisano, head of Sanofi's vaccine unit said, "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."

Sanofi was already producing two Hib-containing vaccines; Pentacel, and ActHib before problems at vaccine and drug manufacturer Merck created a shortage in the marketplace. Lori Lukus, director of public relations for Sanofi Pasteur said, "We will be able to supply about 18 million doses of Hib-containing vaccine to the U.S. in 2009."

In December 2007 Merck suspended production of PedvaxHIB and Comvax two products containing the Hib vaccine due to potential contamination issues.  This subsequently led to the current shortage as Sanofi was unable to immediately increase its production of Hib vaccine products. "Before Merck recalled their Hib vaccines and withdrew from the market, we were supplying about half the Hib vaccine in the U.S., or 8 million doses," Lukus said.

Although 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.

A Merck spokeswoman said the company is now working with regulatory authorities to try to make limited supplies of its meningitis vaccine available by the end of the year. The vaccine which previously accounted for a relatively small portion of Merck's overall sales is expected to be fully available in early 2010.

Children continued to get the initial doses during the period of the vaccine shortage though the CDC had recommended deferring the 12-15 month booster shot for children other than high risk children such as those with immune-system problems who continued to get the booster shots.

The children who didn't receive the booster shot during the shortage will now are able to get it at their next routinely scheduled doctor's office visit. However the CDC added that continuing supply constraints won't allow a mass recall of older children to immediately get booster shots that were deferred.

As the ActHib vaccine is manufactured in France, the increase in Hib vaccine manufacturing will not affect Sanofi’s Swiftwater output of seasonal or swine flu production.

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