Monday, August 31, 2009

CAMJ Editorial: The H1N1 Vaccine Race

 

# 3688

 

 

CMAJ is the Canadian Medical Association Journal, and their editorialists have taken the Canadian government to the woodshed more than once over government health policies.

 

Last year (see CMAJ : A Scathing Assessment Of Canadian Pandemic Preparedness) they called Canada’s epidemic surveillance and reporting system a `national embarrassment’.

 

Today they run an editorial criticizing the decisions which have led to delays in the approval of an H1N1 vaccine for this fall, calling the Canadian vaccine strategy `flawed’.

 

EDITORIAL

August 31, 2009

The H1N1 vaccine race: Can we beat the pandemic?

 

Canada proudly claims to be the first nation with an influenza pandemic plan — a response, in part, to the lack of vaccine during the 1976 swine flu scare. We are told that there is a guaranteed supply of pandemic vaccine from a domestic source.1 But this is only the first step.

 

The bigger issue is: Will we be able to immunize vulnerable populations in time?

 

Under the current plan, the answer is “No.” Vaccines must pass a regulatory process for licensing, and Health Canada, the licensing authority, has decided to treat this virus like a new subtype rather than a variant H1N1 strain, requiring a more extensive review and a slower rollout.

(Continue . . . )

 

 

The Canadian government made the decision earlier this summer to go with an adjuvanted vaccine – one that contains immune boosting additives that reduce the amount of antigen required for each shot. 

 

The problem is, these adjuvants are not currently approved for use in Canadian flu shots, and the approval process will delay distribution of the vaccine until November . . . or later.   

 

CMAJ is arguing that while an adjuvanted vaccine makes sense in order to assure enough vaccine for the entire nation, a `fast-track’ approval of an unadjuvanted vaccine should be in place to get vaccine to high risk individuals in October.

 

The editorial sums it up this way:

 

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.

 

 

Whether there is time, the inclination, or even the opportunity to change to a duel track vaccine approval process is something, I guess, we’ll have to wait to see.