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FDA Approves Glaxo's Hiberix vaccine

Posted over 9 years ago by Janel Saunders

By Miriam Hill and Don Sapatkin


GlaxoSmithKline P.L.C. has won swift approval from the federal government to produce and sell a booster vaccine against Haemophilus influenzae type b, which should help eliminate shortages of the shot against the deadly disease.

The London drugmaker, which has large operations in the Philadelphia region, said late yesterday that its Hiberix vaccine was approved as a booster dose for children 15 months to 4 years old.

The vaccine targets the bacterial infection known as Hib, which can cause meningitis, pneumonia, and other deadly illnesses. The U.S. Food and Drug Administration granted Glaxoaccelerated approval for Hiberix because Hib vaccines have been in short supply.

Shortages developed after Merck & Co. Inc. announced in December 2007 that it was withdrawing 1.2 million doses of its Hib vaccine because of possible contamination of equipment at its West Point, Montgomery County, facility.

Today, Merck spokeswoman Amy Rose said the company considered restoring availability of Hib vaccine "a top priority." Merck hopes to have a limited supply of its vaccine, PedvaxHIB, available by the end of this year. A full supply should be available by the first quarter of 2010, she said.

Merck is investing $1 billion to update processes and equipment in West Point and to expand or build new facilities in Virginia, North Carolina, France, and Ireland to ensure long-term supply, Rose said.

Sanofi Pasteur Inc., which makes another Hib vaccine at its plant in Swiftwater, Pa., increased production but could not completely make up for the shortfall.

Before vaccines became available, Haemophilus influenzae type b, which is unrelated to the influenza known as the flu, infected 20,000 children under age 5 each year. About 1,000 died, and many of those who survived were left mentally retarded.

Vaccines had virtually eradicated the disease 20 years ago, but the Centers for Disease Control and Prevention said Hib had started to return this year. The agency could not immediately provide numbers and said it did not know whether the resurgence was connected to the shortage.

As a result of the shortages, however, the CDC had recommended that booster shots be temporarily delayed until supplies improved. Some experts said they believed that the resulting slight reduction in "herd" immunity made children whose parents declined to allow even the primary series of Hib vaccinations more vulnerable than they had been previously.

Over the last year, Pennsylvania health officials reported nine confirmed or suspected cases of Hib disease, resulting in three deaths. Most of those children did not get any doses of the vaccine, state authorities said.

Reports of new cases spurred Glaxo to act quickly.

"This was not business as usual. GlaxoSmithKline mobilized people and resources to get this vaccine to market as quickly as possible to help children avoid a potentially fatal disease," said Remon Abu-Elyazeed, Glaxo's North America head of pediatric vaccines.

The CDC lifted its recommendation to delay Hib booster shots in June. Today, the agency urged parents to check with pediatricians to see whether their children's vaccines were up to date and find out whether a Hib booster was needed.

The vaccine is given as a series of either two or three primary shots, with a booster normally administered between 12 and 15 months of age.

Hiberix is already on the market in 100 countries, Abu-Elyazeed said. Glaxo will make the vaccine in Rixensart, Belgium, but will complete packaging at its new operations in Marietta, Pa.



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