November 27, 2015


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Report used in shelving HIV-vaccine facility flawed: critique

OTTAWA — A Canadian vaccine expert says there are fatal flaws in a study the government used as a main reason to kill off a plan to build an HIV-vaccine pilot-manufacturing facility in Canada.

"This study is fatally flawed by its failure to place priority on the quality aspects of clinical materials manufacturing," wrote Don Gerson, in a critique dated March 8.

The critique was raised this morning at the House of Commons Health Committee.

Gerson, currently the president of adult vaccine manufacturer PnuVax, is a pharmaceutical and vaccine industry consultant. He was involved in the initial process to review bids for an HIV-vaccine pilot-manufacturing facility which narrowed down interested parties to four finalists.

The HIV-vaccine facility was supposed to be the centrepiece of the Canadian HIV Vaccine Initiative but it was cancelled last month when the government said none of the proponents met the criteria and a study by the Gates Foundation said such a facility was no longer needed.

Gerson's critique is of the Gates Foundation study, which was completed last July but only released publicly in February when PHAC confirmed the vaccine facility was dead. The study says the capacity in North America and Europe to produce HIV vaccines for clinical trials has improved in the last few years, the HIV community has traditionally relied on a small number of "go-to" suppliers, and a significant number of additional suppliers were identified.

However Gerson said there was a very good reason the HIV community was limiting the number of suppliers it trusted — they are "the only ones that can provide the full quality" of manufacturing needed to support the clinical trials of HIV vaccine which are critical to developing an effective product.

"So much depends on these clinical trials that it is inexcusable to manufacture Clinical Trial lots of a vaccine. . .in a facility and by a process that does not meet the standards required to give a correct and useful result," Gerson wrote.

He noted it was the because there were not enough manufacturing facilities that met the stringent requirements known as Good Manufacturing Practices that the entire Canadian vaccine facility project was initiated.

Dr. David Butler-Jones, head of the Public Health Agency of Canada, said the Gerson critique will not resurrect the project.

"This is a critique of a study," he said. "This is not another assessment. The Gates Foundation and ourselves are satisfied we have enough information to make the decision."

But NDP Health Critic Judy Wasylycia-Leis said the Gerson critique should be enough to have PHAC "revisit the process."

She said having a non-profit agency set up to produce the vaccines was a key criteria when the project was initiated.

"It begs the question how that important part of the process was suddenly irrelevant," she said.

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