Feds, ID Biomedical sign flu vaccine deal

Pact will see company produce a prototype for testing

By Helen Branswell
Canadian Press
November 29, 2005

TORONTO -- The federal government and Canada's flu vaccine manufacturer have finally signed a deal that will see ID Biomedical produce a prototype H5N1 flu vaccine for clinical testing in this country -- a year after company officials first pitched the idea to federal pandemic planners.

Protracted negotiations between the two parties over issues including the thorny question of vaccine liability leaves Canada, which had been one of the first countries to indicate it would make an H5N1 vaccine, now trailing a growing list of nations in this area of research.

Health Minister Ujjal Dosanjh called the contract an important component of the country's pandemic readiness.

"The investment in the development and testing of a prototype pandemic vaccine represents a significant step towards improving our preparedness," he said in a statement.

"We need to invest now in building our scientific knowledge and production capacity so that we can produce a vaccine as quickly as possible when it's needed."

But the prototype vaccine won't be ready for testing until late 2006. And the process of testing and licensing a prototype H5N1 vaccine will take another year on top of that, Dr. Theresa Tam of the Public Health Agency of Canada said Monday.

"From my perspective, yes, it would be good to have started this earlier on," admitted Tam, the agency's associate director of immunization and respiratory infections.

But she noted the agreement hammered out over a number of months settles the issue of legal liability. And having that out of the way now will put the country in a stronger position when a pandemic begins.

"In fact, having dealt with this quite difficult situation ahead of time to me is actually quite a milestone," Tam said.

Under the deal, if a pandemic vaccine is rushed to market without undergoing the full testing and licensing process, Canada will have to compensate the manufacturer for any claims that might arise if there are adverse reactions to the vaccine.

If a pandemic vaccine is taken through testing and full licensure, however, "any obligation for compensation would end for Canada."

Dr. Tony Holler, CEO of ID Biomedical, said ensuring the company was adequately protected was an important part of the negotiations.

"It was one of the things we wanted to make sure: If our product didn't have time to go through the whole clinical trial scenario and was released to the public, that we were indemnified," he said in an interview.

ID Biomedical proposed the prototype vaccine project to the federal government last November and officials of the Public Health Agency were able to persuade the federal government to fund the work in the February budget.

But the spending plan didn't pass until mid-May, holding up the project. Once it passed, lawyers for Public Works Canada and ID Biomedical set to work on a deal that was initially expected to be completed relatively quickly.

Delivery of the prototype vaccine was expected in time to run clinical trials in the late summer or early fall of 2006.

Instead, the negotiations took considerably longer.