# 3379
Helen Branswell of the Canadian Press brings us some important background on the testing process required before a pandemic vaccine can be deemed safe and effective, and released to the public.
No one takes us behind the scenes in the world of influenza and science better than Helen Branswell. I’ve just posted the opening paragraphs, follow the links to read Ms. Branswell’s entire article.
Bringing pandemic vaccine to flu clinics first requires animal, human testing
By Helen Branswell – 2 hours ago
TORONTO — If you went by statements from the pharmaceutical industry, you might be tempted to think it was nearly time to roll up your sleeve for a swine flu shot.
In the so-called race to produce pandemic vaccine, several companies have declared themselves frontrunners, suggesting their products are on the verge of being ready.
But are they on the verge of being ready for use? Maybe not just yet.
"I've seen a couple of press releases ... saying `By early summer we're going to have something.' They may have something off the production line," Halifax vaccinologist Dr. Scott Halperin says with a chuckle.
Making vaccine and convincing regulatory agencies that the stuff is safe to inject into humans are separate matters. That is always the case but is especially true when the vaccine in question is to protect against swine flu.
The difficulties in delivering a `vaccine in the fall’ have been a frequent topic in this blog, with just a few relevant entries listed below.
A Vaccine Reality Check From The CDC
Vaccine Expectations
The Tracks Of Our Tiers
A Vaccine Reality Check
CIDRAP News: Major Hurdles To Get To A Vaccine
While it is likely that some H1N1 vaccine will be delivered to some countries later this fall, how much that will be, and who will actually receive it are open questions.
The decision to vaccinate against the H1N1 swine flu virus hasn’t even been made here in the United States, and probably won’t be made until late summer.
There are a great many obstacles that must be overcome, including:
- 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.
None of this is to suggest that a vaccine shouldn’t be created, and distributed to as many people as possible.
But we do need to have realistic expectations about when a vaccine will be available, and in what quantity.
And right now, we don’t have the answers to those questions.
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