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Triple Threat: Merck & Co.

PharmaManufacturing.com
12/14/2007

When it rains it pours…Or so is the case for Merck & Co. this week as they battle serious vaccine recalls and heavy environmental fines.

According to yesterday's Forbes report, Merck will pay $20M in violations for chemical spills in June and August of last year that killed 1,000+ fish in Wissahickon Creek and caused the city to temporarily shut down drinking water intakes. Wissahickon Creek is the source for 40 percent of Philadelphia's drinking water.

On June 13, 2006, Merck's vaccine facility in West Point, Montgomery County, discharged about 25 gallons of potassium thiocyanate into the Upper Gwynedd Township wastewater treatment system. The chemical compound apparently turned toxic when it reacted with the chlorination system.

Just two month later, on Aug. 8, Merck caused a foamy discharge into the Wissahickon by releasing a protein solution into the sewage system. Later that same week, more foam floated down stream due to Merck's faulty release of cleaning agents.

U.S. Attorney Patrick J. Meehan said in a statement, "Perhaps more than anything else, this settlement says to every company that discharges dangerous chemicals as part of its operations that it is accountable to the environment and the community...No one should have to wonder, when they walk into the kitchen for a glass of water, if what they are about to drink is going to make them or their children sick."

While parents should not have to wonder whether drinking water is making their children sick, they will have to worry whether their children's recent vaccinations are.

On Dec. 12 Merck recalled 1.2 million doses of its children's vaccine Pedvaxhib due to sterilization issues in this same West Point, Pa. facility. The vaccine protects against Haemophilus influenzae type b disease which can cause bacterial meningitis and pneumonia in small children.

Quality-control checks at the manufacturing facility found contamination in its production equipment that may have allowed micro-organisms to survive sterilization. Merck is one of two providers of the Hib vaccine, and the recall affects shipped from the facility as early as April 2007. Sanofi-Pasteur supplies the remaining half of the 14 million dose requirement.

Merck said in a statement on Dec. 12 that “The potential for contamination of any individual vaccine is low, and if present, the level of contamination would be low.”

According to the US Centers for Disease Control (CDC), no cases of injury or harm linked to the potentially-contaminated vaccine have been reported thus far from the 11 affected batches.

But that is not the case for the controversial MMR=II vaccine, administered as a three-in-one for measles, mumps, and rubella.

Earlier this week, MerckFrosst Canada, a subsidiary of Merck, suspended use of three batches of the vaccine after reports of anaphylaxis, a serious allergic reaction, surfaced in five adults who had been given the treatment as part of a catch-up campaign in Alberta.

The MMR vaccine is usually given to children twice in their second year, but due to a recent mumps outbreak in Canada, a campaign began in Alberta to administer the vaccine to young adults. Canadians up to age 40 were advised to receive two doses of the vaccine by the Canadian national advisory committee.

While all five affected adults have recovered, the suspended lots, affecting 200,000 doses, have been suspended until further examination can be done on the manufacturing issues at MerckFrosst Canada.

Sheila Murphy, public affairs manager for MerckFrosst Canada’s vaccine department said in a public statement, “Cases have been related to one lot in Alberta and they're amongst these young adults, so there have been no reported cases with babies.”

Luckily, the only thing the babies have to worry about is their Hib vaccination.