Health Canada would like to set the record straight on the claims made in the Aug. 31, 2009, editorial “The H1N1 vaccine race: Can we beat the pandemic? 1 ” In particular: Although we are treating this vaccine as a new product, which it is, the extra work involved in the authorization was largely completed before this current pandemic was declared. Furthermore, as the regulatory review of the adjuvant has already been completed as part of the review of the H5N1 vaccine, no additional data on the adjuvant itself is being asked for by Health Canada. Our remaining evaluation activities are focused on the H1N1 antigen component of the vaccine. In summary, there will be no delay in getting a pandemic influenza vaccine to Canadians due to regulatory requirements. Health Canada is working closely with the manufacturer to review proposed production timelines for Canada and we will be ready to make a decision on the authorization of an adjuvanted and a non-adjuvanted pandemic vaccine as soon as one becomes available and a public health determination has been made to use one, the other, or both.
Footnotes
-
For the full letter, go to: www.cmaj.ca/cgi/eletters/cmaj.091560#186702
REFERENCE
- 1.↵