Swine Flu Vaccine – Rushed to Approval?

Canadian H1N1 Vaccination Antigen Passed Virtually Untested

Oct 29, 2009

Think the swine flu vaccine was carefully tested before being injected into Canadian children, pregnant women, and the general population? Think again. It was a rush job.

PHAC, the Public Health Agency of Canada, claims the lack of testing of the H1N1 vaccine is a myth. Their FAQ contains this statement:

Fact 3: Careful research into the safety of any vaccine is done prior to its widespread use. The requirements for vaccines approved for sale in Canada are stringent. Every vaccine lot is safety-tested .... Health Canada will ...ensure the vaccine is safe and effective before it is authorized for use in Canada.

Health Canada Says "No Canadian Tested" with Swine Flu Vaccine

However, according to a report by the Ottawa Citizen, "Health Canada approved this country's H1N1 vaccine without evaluating its safety and effectiveness on a single Canadian citizen. Instead, the federal drug regulator approved the pandemic vaccine based on the results of a small clinical trial in Belgium."

In that study, says the Citizen, 130 healthy adult volunteers, aged 18 to 60, were inoculated with a variant of Canada's vaccine made at a different facility (the vaccine used in the Belgian study was manufactured by GlaxoSmithKline in Germany under the trade name Arepanrix™, while Canada's vaccine is produced by GSK in Ste-Foy, Quebec).

"Health Canada officials released the information late Friday," continues the Citizen report, "in response to questions submitted by the Ottawa Citizen about what scientific evidence was used to establish the safety and effectiveness of the H1N1 vaccine."

Health Canada Says "No Data" for Swine Flu Vaccine

So, based on a single trial of just over 100 adults, the vaccine is deemed safe for the elderly, for children, for pregnant women, for nursing moms all across Canada (and to be fair, that decision was based also on the results of millions of seasonal flu vaccinations in the past).

Nonetheless, as the Health Canada site further reveals, the "myth" of the H1N1 flu vaccine being untested appears to have strong elements of fact. The document "Product Information Leaflet Arepanrix™ H1N1 AS03-Adjuvanted H1N1 Pandemic Influenza Vaccine", Version 1, Oct. 21, 2009 retrieved from the HC site on Oct. 26 contains the following quotes:

So that's the "careful research" into the safety of the H1N1 vaccine that was "done prior to its widespread use" in Canada. That single test, combined with assumptions based on other similar vaccines, was enough to meet the "stringent" requirement for vaccines approved for sale in Canada.

Swine Flu Disease Worse than H1N1 Vaccine Effects, says Health Canada

Health Canada considers that the dangers of vaccine-preventable diseases are much greater than the risk from a serious reaction to a vaccine. This article is not intended to dissuade anyone from taking the H1N1 vaccine, seasonal flu vaccine, or any other related medication.

The copyright of the article Swine Flu Vaccine – Rushed to Approval? in Public Healthcare Issues is owned by Thomas Alan Gray. Permission to republish Swine Flu Vaccine – Rushed to Approval? in print or online must be granted by the author in writing.