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Maker of HPV Vaccine Under Fire

Regulators found problems at US plant where Gardasil is made for BC.

Andrew MacLeod 16 May 2008TheTyee.ca

Andrew MacLeod is The Tyee's Legislative Bureau Chief in Victoria. You can reach him here.

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Manufacturer Merck scrutinized.

While British Columbia Health Minister George Abbott was announcing the province will provide a controversial new vaccine starting in September with assurances that it is "safe," the American Food and Drug Administration was threatening to close the factory where it is made.

The B.C. Centre for Disease Control's director of immunization programs, Monika Naus, said she had seen the media reports on the problems at Merck's plant in West Point, Pennsylvania. She believed the same plant supplies vaccines to Canada, she said, but it was unclear whether any of the lots coming here were affected. "I basically know what you know. The company's taking it very seriously."

The province gets several common vaccines from Merck, she said, including ones used for mumps, hepatitis A and hepatitis B. Merck will start supplying Gardasil, used to prevent strains of the human papilloma virus (HPV) that are associated with cervical cancer, to B.C. in August.

A Merck Frosst Canada Ltd. spokesperson in Montreal, Sheila Murphy, confirmed the company makes vaccines for export to Canada at the same Pennsylvania plant the FDA is investigating. Merck will do what it needs to do to meet the FDA's requirements, she said. "We're taking care of it."

In Canada, monitoring of vaccines or other treatments is done by the federal government. A Health Canada spokesperson said in an e-mailed response to questions, "Health Canada is monitoring the situation and reviewing Merck Frosst's response to the FDA . . . . This will inform the assessment that is underway regarding the impacts this warning letter has (if any) on the safety of vaccines available in Canada."

Warning letter

The FDA's 3,500-word, April 28, 2008, letter, addressed to Merck president and CEO Richard Clark, said the warning was the result of inspections conducted at the plant between Nov. 26, 2007 and Jan. 17, 2008.

"The FDA investigators documented significant deviations from current good manufacturing practice . . . in the manufacture of licensed biological vaccine products, bulk drug substances, and drug components," the letter said.

For example, there were shipments of MMR vaccine that failed visual inspections for "critical defects" that were distributed anyway, even though the problems had not been thoroughly investigated. Nor were staff investigating and documenting problems as well as they should, the letter said.

"The deficiencies described in this letter are indicative of your quality control unit's inability to fulfill its responsibility to assure the identity, strength, quality, and purity of your drug product and drug substance."

The letter said Merck responded on Feb. 15, but the FDA said "we believe your response(s) did not provide sufficient detail to fully assess the adequacy of the corrective actions." It concluded, "Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions may include license suspension and/or revocation, seizure or injunction."

Canadian vaccines imported

Merck's Murphy said the only thing unusual about the letter is that it became public. "From our perspective, Merck and the FDA work very closely together," she said. "It's the kind of communication that happens all the time."

It is normal business that the regulator asks questions and the company responds, she said. These sorts of letters are sent frequently, she added. "What makes it out of the ordinary is someone got their hands on the communication."

Asked what guarantees Canadians have that imported vaccines are safe, she said, "I think if you're looking for other assurances, don't forget I work for the company, you're going to have to call Health Canada. They're the agency that controls our business here in Canada."

About 70 per cent of vaccines are imported, according to the e-mail from Health Canada's spokesperson. Health Canada officials will often visit manufacturing plants before allowing a new vaccine on the market. Once a vaccine is approved, samples of each lot are sent to Health Canada, along with the company's own test results. The agency may then do its own "targeted" testing on the lot.

Health Canada also pays attention to reports of adverse reactions, he said, and works closely with other regulators such as the FDA. When there are concerns, he said, officials may visit the plant in question.

Other vaccines recalled

B.C. will start providing Merck's Gardasil to young women in Grades 6 and 9 in September. They will be given three shots over six months as part of the $39 million, federally-funded program. After three years, the province will start providing the vaccine only to girls in Grade 6.

Taking the vaccine will be voluntary, though provincial health officer Perry Kendall said he hopes 90 per cent of those eligible will get the shots.

There have been other concerns raised about Merck vaccines in recent months. In December, the FDA recalled 13 lots of vaccines for hepatitis B, pneumonia and meningitis. News reports said at the time the company was having problems with sterility at its West Point, Pennsylvania plant.

Also in December, Health Canada warned people not to use three lots -- some 200,000 doses -- of Merck's vaccine for measles, mumps and rubella after five Albertans had allergic reactions to the vaccine. All had a previous history of allergies and recovered.

At the time, Merck's Murphy told Reuters news service the company was looking into whether there had been other cases of anaphylaxis related to the vaccine elsewhere in the world and "from the manufacturing side whether there has been any anomaly in the production of the vaccine."

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