# 3167
Over the next few weeks officials at the HHS, the WHO (World Health Organization), and from governments around the world may decide to embark on the most ambitious pandemic vaccine manufacturing and distribution program in history.
To say that numerous challenges lay ahead would be a considerable understatement.
I believe it is imperative that people have an understanding of the complex issues that surround a project of this kind and a realistic expectation of what may - or may not - be able to be accomplished.
In an ongoing series of essays, I hope to lay out some of the technical, logistical, economic, social, ethical, and diplomatic challenges that must be dealt with on the way to getting a pandemic vaccine to the public.
Despite anything you may have read in the papers, or heard on the news, the decision to go ahead with the manufacture of a swine flu vaccine for the next flu season has not been made.
The CDC is growing `seed strains’ of the vaccine so that – if a decision is made to proceed in the next few weeks – vaccine manufacturers can be ready for the next step in the process; producing small `trial lots’ of vaccine for animal and human testing later this summer.
There are many unanswered questions right now that will determine how much vaccine can be produced, and by what timetable.
We don’t know, for instance, how well this virus will grow in eggs (not all viruses are created equal in this department), or how much antigen each person will need to provoke an immune response.
Estimates of a global manufacturing capacity of 1 to 2 billion doses a year are based on `best case' assumptions.
Whether these estimates can be met is unknown.
If two shots are required per person (a distinct possibility), then the actual number of people who can be vaccinated is cut in half.
And of course, simply producing a vaccine isn’t enough.
You have to distribute it.
Internationally, nationally, and locally.
And that presents serious logistical, ethical, social, economic, political and diplomatic challenges.
Before anyone assumes that I am lobbying against making a vaccine . . . rest assured, I’m not.
But I do believe that the public needs to have realistic expectations of what can be done, and how quickly, and an understanding of what might not go as planned.
Gearing up to manufacture, distribute, and dispense a pandemic vaccine to a billion or more people over the next 12 months or so is the public health equivalent of NASA putting a man on the moon, or the building the Panama Canal.
It’s a tall order.
Perhaps not impossible, but certainly daunting.
And if the decision to go ahead is made, a lot of very good people at all levels of public health and government will be asked to go above and beyond the call of duty to try to make it happen.
Some will even be betting their reputations and careers on the assumption that they can do something that has never been successfully done before.
The last time a national pandemic vaccination program was attempted was 33 years ago (see Deja Flu, All Over Again), and its failure cost the Director of the CDC his job, probably impacted the ‘76 Presidential election, and adversely affected the lives of hundreds of vaccine recipients.
But the only thing worse than trying and failing would be to not try and have a major loss of life due to not having a vaccine.
Talk about being between a rock and a hard place.
Be glad that this isn’t your call – be glad it isn’t your job to decide whether to go forward with a massive, expensive, and potentially risky vaccine program when we don’t even know if a pandemic is coming.
As if this decision isn’t difficult enough, some other challenges that almost certainly will arise include:
- Over the coming months we are likely to see intense diplomatic wrangling and serious arm-twisting over what countries get vaccine, in what quantity, and in what order.
- Internally, each country that actually receives vaccine is going to have to decide how to prioritize who gets vaccinated early, and who must wait.
- Public Health officials will likely find that many anti-vaccine activists, conspiracy theorists, and skeptics will oppose the program and will use the Internet and the media to promote their agenda.
- And should there be adverse reactions to the vaccine (and out of hundreds of millions of doses, there probably will be a few), we may see a serious backlash against taking the vaccine by the public, such as we saw in 1976.
- And there is always the possibility that the current strain of the virus will mutate over the summer or fall, rendering any vaccine created on today’s strain less effective.
And these are just some of the most obvious obstacles. Over time, I expect plenty of others to appear.
I’m hoping that people keep in mind how tough this job will be, and that a great many things are beyond the control of any single government or agency.
For now, the decision before the WHO, and the HHS is whether to go forward with trial lots of a vaccine, and then on to animal and human testing later this summer.
There will be other, bigger decisions regarding production runs and distribution of any vaccine that can be held off until later in the summer and fall.
Whether we see a pandemic this winter or fall is completely unknowable.
But over the next few months the governments of the world will have to grapple with that distinct possibility, and hopefully find ways to work together to confront a common threat.
Hopefully this turns out to be a drill, instead of a final exam.
But any way you slice it, it will be a big test.
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