Tuesday, May 19, 2009

WHO: Ad Hoc Report On Swine Flu Vaccine Production

 

 


# 3221

 

 

 

This morning the WHO released a 4 page ad hoc policy advisory on the production of a swine flu vaccine.  You can view it in PDF form by clicking this LINK or the graphic below.

 

 

image

 

 

The two big news items to come out of this report are that production of an H1N1 vaccine would have to be delayed until at least mid-July (which means little or no vaccine before December-January), and that in the ensuing 12 months up to 4.9 billion doses of vaccine could be produced.

 

In my last blog, I called that assessment `generous’.

 

Here is how they came up with that number.

 

A review of 2009 production status for northern hemisphere seasonal vaccine indicates that industry plans to produce approximately 480 million doses of trivalent seasonal vaccine in 2009. Of this, 350 and 430 million doses will be available by 30 June and 31 July 2009, respectively.

 

For influenza A (H1N1), it is estimated that up to 4.9 billion doses could be produced over a 12-month period after the initiation of full-scale production if

 

1. There is a vaccine yield equivalent to that routinely obtained for seasonal vaccine and

2. There is use of the most dose-sparing formulations.


In this situation, there is a potential access for the UN of supplies of up to 400 million doses.

 

 

The `most dose-sparing formulation’ means less antigen than normally used in a flu vaccine (probably 3-5 mcg), with an adjuvant (most of which would have regulatory hurdles here in the US), and the number who could be vaccinated would depend on whether a person required one, or (likely) two doses.

 

And then, there’s that whole distribution thing.

 

Not impossible, but I’d hate to even imagine the Vegas line on them pulling it off.