Flu vaccine plan will be too slow: CMAJ

Canada's approach to vaccinating people againstswine fluis too slow to protect the most vulnerable, an editorial in Monday's Canadian Medical Association Journal says.

Health Canada has chosen to include an adjuvant a substanceused to stretch a vaccine's active ingredient and boost immune response to the serum in the Canadian version of the vaccine against the H1N1 virus. Using an adjuvant requires a slower, more thorough licensing review process but ultimately allows more people to be immunized.

This approach is slower than providing the vaccine without adjuvant to high-risk groups to allow them to be immunized quickly, as the U.S.,Europe and Australia are doing, Dr. Paul Hbert, editor-in-chief, and Dr. Noni MacDonald, senior editor of public health, said in their editorial.

"Time is running out," the doctors wrote. "Only by providing fast-track standard vaccine can high-risk groups be protected in a timely way, while the general public awaits the arrival of the adjuvant vaccine."

Protect high-risk Canadians

Complications such as severe acute lung injuries caused by the H1N1 pandemic strainhave been mainly in adults, often First Nations people, those with chronic medical conditions and women late in pregnancy. Younger children have also been admitted to hospital at higher rates.

The earlier a vaccine is rolled for these high-risk individuals, the greater the chance to protect them before flu season peaks. It also reducesthe burden on hospitals and scarce intensive care spaces, the editorial writers argued.

"Having enough vaccine for every Canadian would make more sense if the pandemic virus were highly virulent for large proportions of the population. But given current evidence, it seems a poorer choice than providing coverage to high-risk groups as early as possible."

Health Canada has chosen to treat this pandemic virus like a new subtype, whichrequires more extensive review and a slower rollout than if it were considered a variant strain of H1N1, the editorial writers said.

Vaccine plan 'highly flexible,' agency says

To protect the public, health professionals need access to standard vaccines by early October and vaccine with adjuvant no later than mid-November, they suggested.

The pair stressed they are not suggesting sacrificing safety, but highlighting the need to adjust plans quickly depending on the results of safety and effectiveness trials that will start to be completed soon.

Using an adjuvant might make sense if results suggest that the vaccine is not effective without it, but if results show a good performance from fast-tracked vaccine without the adjuvant, Canada currently has no way to license such a vaccine quickly, the editors said.

In a statement on Monday, the Public Health Agency of Canada disputed the criticism.

"Canada has a highly flexible regulatory plan that can be swiftly adjusted to meet public health needs," the agency said.

The agency added it's balancing theneed for speed in getting a vaccine to Canadians with gathering as much information as possibleon vaccine safety and effectiveness.