Merck recalls 1.2 mln doses of children's vaccines

Merck recalls 1.2 mln doses of children's vaccines
A general view shows the Merck and Co. facility in Rahway, New Jersey, November 28, 2005. Merck on Wednesday voluntarily recalled about 1.2 million doses of its widely used children's vaccines after quality-control checks found production equipment may not have been properly sterilized. (Jeff Zelevansky/Reuters)WASHINGTON (Reuters) - Merck & Co Inc on Wednesdayvoluntarily recalled about 1.2 million doses of its widely usedchildren's vaccines after quality-control checks foundproduction equipment may not have been properly sterilized.
The vaccines protect against Hib disease (Haemophilusinfluenzae type b), which used to be the leading cause ofbacterial meningitis in children less than 5 years old,according to the U.S. Centers for Disease Control andPrevention.
Merck said it recalled 11 lots of PedvaxHIB vaccine and twolots of its Comvax vaccine due to lack of assurance of productsterility. Both of the recalled vaccines protect against Hiband other conditions. Comvax also prevents hepatitis B.
The vaccines were manufactured in West Point, Pennsylvania,and distributed starting in April 2007. All but one lot wasdistributed in the United States, the company said.
"The potential for contamination of any individual vaccineis low, and, if present, the level of contamination would below," Merck said.
Sterility tests of the vaccine lots subjected to recall didnot turn up any contamination, said Merck, which added that therecall does not affect any other vaccines it manufactures.
Children who have received the affected vaccine do not needto be revaccinated because efficacy was not compromised, saidDr. Anne Schuchat, director of the CDC's National Center forImmunization and Respiratory Diseases.
She advised parents to look for signs of infection at thesite of the inoculation in the days following the injection.
"After a week, you would definitely be out of the woods,"Schuchat said.
Before vaccination became common, Hib struck one child outof every 200 in that age group, causing permanent brain damagein a quarter and killing 1 in 20.
The CDC has recommended that children receive Hib vaccinefor nearly a decade. Fewer than 100 documented Hib casescurrently are reported in the United States each year.
Health officials said they have urged Sanofi Pasteur,Sanofi-Aventis' vaccine business, to boost supplies in a bid tofill the gap caused by the recall.
The United States requires about 14 million doses annuallyto fully vaccinate babies and toddlers, and officials said theyplanned to tap vaccine stockpiles to help meet the need.
"We do expect there to be a shortage. The extent of thatwe're trying to find out," said the CDC's Schuchat. She addedthat the recall does not pose an immediate health risk becausemore than 90 percent of U.S. children have received thevaccine.
"We have a cushion of protection as we go into the recall,"Schuchat said.
In November, Merck agreed to pay $4.85 billion to settlemost claims that Vioxx, its withdrawn painkiller, caused heartattacks and strokes in thousands of users.
Shares in Whitehouse Station, New Jersey-based Merck lost68 cents, or 1.1 percent, to close at $59.72 on the New YorkStock Exchange.
(Reporting by Lisa Richwine, Maggie Fox and Lisa Baertlein,Editing by Gary Hill, Richard Chang)