# 3527
For reasons that, quite frankly, elude me . . . it seems as if a lot of public officials around the world are awfully quick to promise too much, too soon in regards to delivering a pandemic vaccine.
The average person in the United States, and probably in the UK and of Europe as well, no doubt believes they will be rolling up their sleeves for a swine flu shot in September . . . or perhaps October or November at the latest.
And given the almost non-stop assurances in the media that a vaccine will be available `in the fall’, one can hardly blame them.
I’ve had people tell me that `Why bother? They’ll have the flu shots this fall . . . I heard it on the news last night . . . ‘, when I’ve tried to talk about other mitigation efforts like social distancing, hand washing, and getting a pneumovax shot.
Today, in The London Paper we get this bit of encouragement.
Swine flu vaccine to ship in September, says GlaxoSmithKline
London will get first doses of pandemic jab in the autumn, says pharmaceutical company commissioned by WHO to produce the vaccine
by: Lara Deauville
22 July 2009
LONDON will start getting supplies of swine flu vaccine by September, one of the manufacturers producing the jab has said.
GlaxoSmithKline, which is one of several companies commissioned by the World Health Organisation (WHO) to produce a vaccine for the pandemic virus, said it had already agreed contracts for 195 million doses with 16 countries worldwide.
The drug firm said it expected further "significant orders" of the H1N1 vaccine and announced plans to triple the availability of its swine flu treatment Relenza to 190 million doses per year by the end of 2009.
In addition Glaxo also has agreements worth £152.3m with the US government to supply ingredients for the vaccine and Relenza.
It’s all very upbeat. It’s only if you read the entire story (and many people don’t) that you start seeing tiny cracks in the mortar of this article.
More than halfway down the page we get this vague caveat:
Witty said the speed that the vaccine could be produced would depend on the development process - a detail that the company will discover in the next few weeks.
He anticipates shipments will begin in September and increase in volume towards 2010.
How many Londoners, reading this article, are going to come away expecting a vaccine this fall? More than a few, I would think.
While a disclaimer was buried in the story, the impression this article leaves is that there will be vaccines and antivirals available this fall, so people needn’t worry.
Earlier this year, in late April, the WHO announced that under a best-case scenario as many as 2 billion people might receive a swine flu vaccination in the first year of a pandemic.
At the time, in a blog entitled A Vaccine Reality Check, I listed off the top of my head some `complications’ that could impact the production and distribution of a vaccine.
- The virus could mutate over the summer or fall, possibly rendering any vaccine being manufactured now less protective (or even useless).
- The virus may not grow well in eggs (that happens sometimes), reducing the amount of antigen that can be produced.
- They could discover problems during the animal and human testing phase, which can’t even begin until late July.
- The much vaunted global manufacturing capacity may not be as high as some have projected.
- People may need more than the standard 15 mcg flu shot to provoke an immune response, or need two shots, which would cut down on the number of doses that could be produced.
- The logistics of delivering a (prioritized) vaccine to hundreds of millions of people (possibly in two shots a month apart) over a short period of time are tremendous.
- And of course, there could be diplomatic wrangling over the sharing of vaccines with developing countries, or over the export of vaccine from the manufacturer’s country until their needs have been met.
Today we are now aware of concerns over the #2 item in my hit parade : The virus may not grow well in eggs.
(I’m not all that smart,btw. Maryn McKenna mentioned the possibility a week earlier in a CIDRAP article)
In fact, reports over the past couple of weeks (see Vaccine Yields Continue To Disappoint) indicate that the yield may be half (or less) than what was originally hoped for.
Unless that little complication can be rectified, the rosy manufacturing predictions from last April are going to be tough to meet.
It is also pretty much assumed (but won’t be known until clinical trials are conducted) that it will take 2 shots – 3 or 4 weeks apart – to produce adequate immunity in an immunologically naive population.
That comes as no surprise, and has been assumed for years. The surprise would be if only 1 shot is required. Something that was, nevertheless, part of the WHO’s 2 billion vaccinated scenario.
The rest of my list is still in play, by the way. Along with other factors I didn’t mention.
I’m not sure what is really gained by these optimistic statements. Any short term gain in reassuring the public is likely to evaporate this fall if these goals are not met.
If you have a choice between A) promising less, and delivering more or B) Promising too much, and coming up short you are almost always better off going with option A.
If it turns out that a vaccine isn’t widely available in London this fall, people will no doubt notice. They will remember the promises of summer and will no doubt be directing very pointed questions to their elected leaders.
Pointing out the fine print, and saying that `we didn’t say how much vaccine would be available’ isn’t likely to go over very well.
And the same goes for anyplace else in the world expecting a vaccine this fall and winter.
Creating, manufacturing, delivering and dispensing hundreds of millions (or billions) of doses of a pandemic vaccine in a matter of months has never been done before.
Not even close. It is a huge undertaking, and is fraught with all sorts of obstacles.
I’m sure that governments and vaccine manufacturers are doing everything they can to boost production. They have a lot riding on the success of this vaccination program, and I hope they are successful.
But there are more potential pitfalls along the way than I can begin to imagine.
And I’m a pretty imaginative guy.
Almost everyone by now is familiar with Murphy’s laws. The old adage that `If anything can go wrong, it will’.
My caution when making estimates is based on years of working as a paramedic. Where one of the lessons I learned very early on was:
Murphy was an optimist.
