Friday, August 14, 2009

Revised Vaccine Estimates From NBSB Meeting



# 3629



Today’s NBSB public meeting wrapped up about 2pm after a 2 hour session that included a lot of good information provided by a number of speakers.    No doubt, there will be other post mortems of this meeting published later today, and the transcript will probably be available online in the next few days.  


So I’ll just hit some of the highlights.


The National Biodefense Safety Board is an advisory committee that helps provide advice and guidance to the Secretary of the HHS.  At issue today were the myriad issues surrounding vaccines, antivirals, and even psychological needs during a pandemic.

The `big news’, if you want to call it that, emerging from today’s meeting comes from a revision in the quantity of pandemic vaccine that is expected to be made available in October.


As of 2-weeks ago, at the July ACIP meeting on vaccines, we heard from Dr. Robin Robinson that 120 million doses of vaccine could be available by October, and that another 80 million doses a month could be expected after that.

Today, that quantity has been `downsized’ to about 45 million doses in October, followed by roughly 20 million doses a week coming online after that.


Problems with manufacturing yields were cited, along with one of the suppliers (CSL of Australia) being unable to export vaccine until `local obligations’ had been met.  


Both of these possibilities have been mentioned before in this blog, (see Branswell: Swine Flu Vaccine Yield Less Than Optimal and Force Majeure).   As we’ve been reminded, often, by Dr. Anne Schuchat at the CDC – vaccine production is unpredictable, and problems can crop up.


So, none of this is terribly surprising.   Disappointing, perhaps.  But not surprising.


Last night we learned that the UK was reassessing when they could reasonably begin their vaccination program, and they have now shifted from an August start to October.   They too have assigned priority groups so that the vaccine can go to those people they feel need it the most.


The numbers coming out today are, of course, subject to change.  New seed strains have been shipped to manufacturers which may increase the yield going forward, although it remains to be seen how they do in a commercial setting. 


The definition of a `dose’ right now is a shot with 15ug of antigen.  Until clinical trials are completed, we won’t know for sure how much antigen will be needed, although it is hoped that the seasonal flu standard of 15ug will work.


So these numbers may shift over the next couple of months.  For better or worse.


The logistics of delivering this vaccine to the arms of 159 million at-risk Americans over the next few months is another issue, with huge obstacles to be overcome.  Not the least of which will be the tracking and surveillance of vaccine recipients, looking for possible adverse reactions.


But there are other considerations, too.   And it is important to realize just how big a job that the CDC, HHS, and public health departments around the country are undertaking here.

Making sure that the vaccine gets manufactured is just the beginning.  There is packaging  (finish and fill) into single dose syringes and multi-dose vials.  There are ancillary supplies, like syringes, alcohol pads, and vaccine record cards that must be distributed to each vaccination site as well.


There will be bulk distribution, setting up vaccination venues across the country, coordinating personnel, crowd control, release forms, security considerations . . . .


Trying to vaccinate 159 million Americans (just the highest risk groups) with TWO shots 3 weeks apart, over a period of just a few months, is huge undertaking. 


It is the public health equivalent of the D-Day landing, or of putting a man on the moon.


As we judge their performance (which, no doubt, we shall), we really need to keep in mind the size and scope of their task.   Complete success, or having things coming off without a hitch, would be too much to ask.  


There are just too many things that can go wrong.  And some, invariably, will.


One of the biggest issues, of course, will be the safety (and effectiveness) of the vaccine.  


And here we won’t have really good information until the vaccine has been deployed and administered to millions of people.   Clinical trials tell us much about the effective dose, but are not designed to pick up on rare adverse side effects.


The working assumption is that this (unadjuvanted) vaccine is as safe as the seasonal flu vaccine, and it is being licensed as a strain change supplement; consistent with seasonal flu strain changes every year.  


Still, memories of the 1976 swine flu vaccine debacle remain strong, and so enhanced tracking and surveillance is planned to make sure that adverse side effects are not showing up due to the vaccine. 


Regardless of what conspiratorialists may say about this vaccine program, you can bet that everyone involved – from the highest levels of government, to Big Pharma, to your local health department – has a lot (careers, political futures, and Corporate finances) riding on the success and safety of this vaccine. 


While I can’t guarantee that they will get this right, I’m absolutely confident that’s their intent.  Which is about as good as you can hope for in a situation like this. 


And lest anyone worry, the panel reiterated that this is to be a VOLUNTARY VACCINATION PROGRAM.    


If you don’t want the vaccine, don’t take it.


Other issues discussed included the beefing up of the US antiviral stockpile – currently sitting at about 84 million courses – with plans to add more pediatric doses of Tamiflu, Relenza and regular Tamiflu this fall.  


We will reportedly be seeing new antiviral guidance from the CDC in the coming weeks, including information on how Americans can receive antivirals earlier in any illness. 


With private doctors likely overwhelmed by millions of flu cases this coming flu season, this is a particularly important subject, and one that has not been talked about much this summer.


I’ll be very interested to see what they come up with.


Hopefully the transcript of the is meeting will appear on the NBSB website in the near future.  When it does, I’ll try to mention it here.


Their July 18th-19th report is available HERE.