# 3220
Anyone who didn’t see this one coming hasn’t been paying attention.
Swine Flu Vaccine Will Take Months, Health Officials Say
By THE ASSOCIATED PRESSPublished: May 19, 2009
Filed at 7:06 a.m. ET
GENEVA (AP) -- Drug manufacturers won't be able to start making a swine flu vaccine until mid-July at the earliest, months later than previous predictions, the World Health Organization said Tuesday.
The disclosure that making a swine flu vaccine is proving more difficult than experts first thought came as U.N. Secretary-General Ban Ki-moon and WHO chief Dr. Margaret Chan met Tuesday with representatives from up to 30 pharmaceutical companies to discuss the subject.
Health officials from around the world are attending WHO's annual meeting in Geneva this week to discuss the outbreak that has infected 9,830 people in over 40 countries, killing 79 of them.
According to vaccine experts convened by WHO last week, swine flu virus is not growing very fast in laboratories, making it difficult for scientists to get the key ingredient they need for a vaccine, the ''seed stock'' from the virus.
The flu experts said vaccine manufacturers will not be ready to produce a swine flu vaccine until mid-July at the earliest, the agency reported Tuesday on its Web site. Previously, WHO officials had estimated that production could start in late May.
The hope was that (and you need to insert a small miracle here) somehow vast quantities of H1N1 vaccine could be produced, and distributed in time for this fall’s flu season.
On May 9th, in A Vaccine Reality Check , I rattled off just a few obstacles that I felt could interfere with that timetable.
- 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.
Apparently #2 on my hit parade has already proven to be a problem; The virus isn’t growing well in the lab.
In this case, the seed stock for a candidate vaccine isn’t growing well, which could prove problematic for mass production later on as well.
All of these other problems are still in play, by the way.
And if you follow the link to read the AP article, the estimates of our being able to produce 5 billion doses of vaccine are – to put it kindly – generous.
The promise of a vaccine, I’m sure, mollifies a lot of fears.
But the logistics of producing, and delivering a vaccine are enormous, and should not be underestimated.
Better, I think, that we lower expectations on having a vaccine (and if we get lucky, hey, we can celebrate), than to make promises today that will likely crumble in the fall.
The CDC, to their credit, has steadfastly refused to speculate on when, or how much, swine flu vaccine will be available.
A course that is looking more prudent every day.
