Provinces halt use of Novartis flu vaccines amid probe
Published Saturday, October 27, 2012 10:26AM EDT
Last Updated Saturday, October 27, 2012 10:47PM EDT
A handful of provinces indicated Saturday that they will stop using Novartis influenza vaccines, after Health Canada suspended distribution of the products over concerns about some batches manufactured in Europe.
British Columbia, Alberta and Manitoba said they will stop using Novartis vaccines on the recommendation of both Health Canada and the Public Health Agency of Canada.
Health Canada announced Friday it will halt distribution of Fluad and Agriflu, after reports surfaced in Europe of tiny clumps of virus particles in some batches of the vaccines made at a production facility in Italy.
The agency is telling doctors and others who administer flu shots to hold off using Novartis vaccines for the time being until a full review of the situation can be completed.
Novartis supplies about 20 per cent of Canada’s flu vaccines. GlaxoSmithKline makes the bulk of Canada's seasonal flu vaccine, although there are also a few other suppliers.
According to a release sent out by B.C.’s Ministry of Health on Saturday, “British Columbia is fully complying with this suspension, and will be stopping use of these vaccines immediately.”
The BC Centre for Disease Control has also sent out a notice to health authorities, informing them of the decision, the statement read.
Novartis products account for 30 per cent of B.C.’s flu vaccine supply, according to the statement from B.C. Health. The agency advised residents that have already been vaccinated that there have not been any safety issues identified with the vaccines.
Alberta Health said Saturday that Agriflu is one of three vaccines the province uses, accounting for about 22 per cent of the total supply. Fluviral and FluMist make up the bulk of the vaccines the province is using this year.
“While there have been no reports of any adverse effects in Alberta with this vaccine, we are following the recommendation to suspend the use of Agriflu until questions of its safety and efficacy are resolved,” Dr. Martin Lavoie, Alberta’s deputy chief medical officer of health, said in a statement.
“We are working with Alberta Health Services and have asked all public health clinics, physicians and pharmacists to stop using this vaccine until the federal review is completed.”
Manitoba said Agriflu accounts for only about one per cent of its vaccine supply, and officials there have advised health-care providers to stop using the product.
The suspensions follow Saskatchewan’s decision to go one step further and temporarily suspend all of its flu shot clinics.
Saskatchewan’s Chief Medical Health Officer Dr. Saqib Shahab said Friday the province would halt its flu clinics during Health Canada’s review.
"We are taking a precautionary measure while this review is underway," Shahab told The Canadian Press Friday evening. "Our program will resume once the Health Canada review is completed."
He said anybody who has already had the flu vaccine should not be unduly concerned.
Novartis’ Fluad is licensed for use in people 65 and older. It contains an adjuvant, which is a substance added to some vaccines to help older adults’ aging immune systems to mount a strong response to the vaccine. Agriflu is a standard seasonal flu vaccine, suitable for anyone over the age of six months.
In a statement issued Friday night, Novartis said more than one million doses of its pre-filled vaccine syringes have already been administered in Europe so far this season and there have been no unexpected adverse events reported.
They said their vaccines passed quality inspections and they are confident the products are safe. And they said that finding small clumps of virus protein in vaccines is not unusual.
"Aggregation of these proteins is not unusual in vaccines manufacturing,” the company said.
Several European countries, including Italy, Germany and Switzerland, suspended distribution of the vaccines this week, after noticing the clumps. European health officials expect to have their investigation into what’s causing the clumps completed in a couple of days.
Health Canada also says that particles in vaccine vials are not uncommon and have no known impact on safety or effectiveness.
Infectious disease specialist Dr. Neil Rau says it’s unfortunate this problem has occurred just as the flu shot season is getting underway.
"You worry that a story like this will make people think there is something dangerous about the flu vaccine, and that is definitely not the case,” Rau said. “This is an abundance of caution.”
Health Canada’s Dr. Paul Gully says Canadians should not avoid getting the flu shot because of this problem.
“Please go forward and get immunized because any possible risk for the vaccine is infinitesimal and is far outweighed by getting the flu and what can be a really nasty disease,” he told CTV News in an interview.