February 27 Flu Update
A new human case has been reported in Egypt, a 4-year old girl.The US has approved the bird flu vaccine, which is safe, but, as noted earlier, may not be very effective.
CIDRAP on the FDA Approval.
Sanofi, in a report submitted to the FDA panel, revealed that two 90-microgram (mcg) doses, administered 28 days apart, generated a protective immune response in 45% of patients. That level is less than the 54% rate reported almost a year ago in the New England Journal of Medicine. The higher rate was based on interim findings, the AP reported yesterday. The researchers used a neutralizing antibody titer of 1:40, a fourfold or more increase in antibody titer, to define adequate immune response.
This report gives a little more nuanced reading to the vaccine story.
“I would think this is almost a Step 1,” said Dr. Robert Couch, an expert in respiratory viruses from Baylor College School of Medicine in Houston. “This is not the answer to the H5 vaccine problem, but this is a first step.”
“We have to look upon this as an interim vaccine,” added Dr. Robert Webster, an authority on avian influenza who is based at St. Jude Children’s Research Hospital in Memphis, Tenn.
Effect Measure also blogs on this vaccine. Here is the salient paragraph.
The amount of viral antigen needed to protect less than half the subjects required two doses of 90 micrograms each. That's twelve times as much antigen as in the current seasonal flu shot, although current flu vaccines have antigen for three different flu viruses (two influenza A and one influenza B), so plausibly these results represent only a factor of four lower productive capacity to make this vaccine. Other vaccines have now been produced with much better ability to produce comparable antibody levels with less antigen, so why the government would put in an order for this vaccine is a bit of a mystery. This vaccine uses egg-based technology and seems doomed to be too ineffective and result in too little productive capacity to make it worthwhile investing in at this point.
Helen Branswell on a GSK plan to sell a pre-pandemic vaccine in the marketplace.
7 more birds have died in Kuwait.
However, Kuwait says there are no human cases.
Northern Vietnam is at high risk of bird flu after their first case emerged...spraying disinfectant is recommended.
The UN is investigating in Laos where the first case has emerged.
ProMed on Hong Kong and Vietnam.
Story in Nigeria notes that the bird flu hits the poor hardest.
Turkey has claimed to have "medically screened" 44,000 people.
EU has a "swat" team ready for winter flu outbreaks (just in time).
The NHS in the UK is coordinating a pandemic summit.
A province in the Philippines says it is bird flu free.
posted by Orange @ 10:03 AM
1 Comments:
Orange;
Lot’s of very good articles you have today on pre-pandemic vaccines.
I’m with Revere again on this topic, but I’d like to chime in with my viewpoint, which is a little different (as usual), when I crunch the numbers. Overall, of course any pre-pandemic H5N1 type vaccine is better than nothing, and countries need something as an emergency stockpile – like, now, as soon as possible. If one adds up the numbers of courses of clade 1 H5N1 vaccines that will be in the US stockpile by the end of 2007, according to the HHS, we should have about 8 million courses (two doses per individual in a course). That will only cover about 3% of the US total population. If the stockpile goal is increased to 20 million courses, it sounds good on the surface, but then that will only cover approximately 7% of the US population – still not enough. Assuming only 45% effective protective immune response by individuals, then this would still only effectively cover 3% of the total people in the US with estimated immunity. That is woefully inadequate, and eternal hope is not a strategy.
For an emergency pre-pandemic H5N1 stockpile of unproven and untested vaccine, I believe we need to increase the effective (i.e. 45% rate) total course amount to equal 10% of the US 300M population, at a minimum. This would mean stockpiling approximately 60M courses, or three times the present stockpile goal of 20M. We absolutely need a 10% minimum coverage of the total US population to innoculate critical health care workers, the military, law enforcement, workers who support the economic and utility infrastructure, critical government personnel, prisoners in jail,and the young, aged, and infirm. That’s a lot of people and a lot of unproven clade 1 and 2 pre-pandemic emergency vaccine and priming. But the best deals in life we get, often do take years to develop.
At the same time, we need to pursue preemptive general prophylaxis options like GSK suggests, and openly offer the H5 type vaccine to individuals who are able and wish to purchase it. To people like me and you. This is an excellent approach to kill two birds with one stone… have an emergency stockpile, plus add the advantage of the development of an affordable preemptive voluntary optional GSK vaccine. The makes absolute sense and would provide an increased margin of safety we presently do not have. Whether pre-pandemic vaccines actually have any utility, or not – is moot, we won’t know until the event occurs, or we will if we have the luxury of running actual human trials beforehand. Right now though, the benefits of this dual approach, far outweigh the risk of societal collapse. This is a classic case where the only price we will know for the vaccine, is the one we will finally pay. I'm willing to pay now.
In your story about Nigeria hitting the poor the hardest, there is no doubt of this, but this is the way of life in third world underdeveloped countries. I especially noted in the article that they are faced with the situation of being totally unable to stop the transport, smuggling or hiding of infected poultry, much like the poor Asian countries, like Indonesia. Realistically, smuggling and transport of poultry will never be resolved anywhere: we can’t even stop the smuggling of counterfeit knock-off merchandise, drugs, stolen vehicles, money or even plants and seeds – and we think anybody in any country is going to eliminate the smuggling of a bunch of 50 cent chickens and ducks ? Maybe in someone’s pipe dream.
The news from Turkey indicates, if I got the numbers right… they screened 44,263 people thus far for H5N1 infection, treated 213 people for “infections” (I presume they were stuffed up with Tamiflu tablets until it popped out of their ears), and miraculously, everybody turns out negative. Absolutely incredible statistics if one were inclined to believe it.
At least China has finally stepped forward today and reported one new human case of bird flu in the Fujian province in the news. They still have a long ways to go to prove their transparency and improve their credibility.
I have concluded that nearly all countries these days are viewing H5N1 infected humans much like a nuclear bomb going off – nobody wants one landing in their back yard.
But sooner or later, the world is eventually going to see the H5N1 mushroom clouds forming on the horizon of some of these countries. There will be no hiding it.
Wulfgang
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