A must-read editorial in the Canadian Medical Association Journal: The H1N1 vaccine race: Can we beat the pandemic? After comparing fast-track and slow-track licensing methods, the editorial concludes:
Other countries, such as Australia, members of the European Union and the United States, plan to license their 2009 pandemic vaccine by the faster path. Some, in fact, are choosing both: fast track licensing for use in high-risk groups and the slower process for the rest of the population.
Health Canada has chosen the slower path. That might be reasonable if the vaccine without adjuvant fails to be effective. But what if ongoing clinical results show good performance of the fast-track vaccine? Can the fast-track approach be used to license such a product quickly? At present, in Canada, the answer is “No.”
We are not suggesting that we sacrifice safety. But we must be able to readjust our plans quickly, depending on results of the soon-to-be completed trials.
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.
Time is running out. Only by providing fast-track standard vaccine might high-risk groups be protected in a timely way, while the general public awaits the arrival of the adjuvant vaccine.
Without an immediate change in policy, high-risk groups in Canada will be waiting for protection, while their US and European counterparts are vaccinated. Health professionals must have access to standard vaccines by early October and to adjuvant vaccine no later than mid-November to protect the public.
Health Canada seems to have forgotten that while being first with a plan is good, being fast to vaccinate will save lives.
