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To: kdono
Thanks so much for posting this transcript. FDA knew in March that the Fujian strain was going to be the problem in the winter, but they were having problems isolating it and getting it to grow in eggs. So they all "reluctantly" voted to keep using the 5-year-old Panama Flu Strain--which has a 50-50 record about helping against Fujian Flu.

I can't say that I disagree with the difficult choice they had to make, but we certainly need to be ready next year with Fujian strain. Flu went through our entire family early this year. First, our nine-month old granddaugher, then her 2 year old sister, then me, then their mom, and their dad. I'd had a flu shot six weeks ago, and only had a mild bout of flu. Everyone recovered, although the mom lost her job over this, and dad is still not back at work.

18 posted on 12/13/2003 10:44:08 PM PST by DJtex
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To: DJtex
voted to keep using the 5-year-old Panama Flu Strain--which has a 50-50 record about helping against Fujian Flu.

Unfortunately, Panama is nowhere near 50/50 against Fujian. At their earlier meeting they were shown ferret data which showed that ferrets immunized with Panama had titers of 640 to 1280 against Panama, but only 80 against Fujian (and the Panama vaccine doesn't even work that well against Panama - in spite of being used worldwide for the past 4 years, 1/4 of the US cases are still Panama).

Their choices were not ideal, but there was only one correct vote, which was to passage the virus once in MDCK cells and then grow it in eggs. MDCK cells were already in registration for vaccine production so pathogen free cell lines existed.

Making Fujian THIS year was very doable.

20 posted on 12/13/2003 11:19:48 PM PST by kdono
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To: DJtex
Here is one media interpretation of the transcript:

FDA balked at riskier, but better, flu shot
By David Migoya and Marsha Austin
THE DENVER POST

Federal regulators could have approved a flu vaccine that protected the public against the deadly strain sweeping across the country, but would have had to use a controversial and risky method to do it.

A leading national expert on infectious diseases told a Food and Drug Administration committee in February and again in March that it would be a mistake if this year's vaccine didn't guard against a potentially lethal strain of flu that was beginning to emerge in the Southern Hemisphere.

Dr. Peter Palese warned that the flu strain - known as A-Fujian/411/2002 - seemed likely to hit the United States and that drastic measures were required to protect public health. Creating a vaccine that offered only moderate safeguards against the new strain was a bad idea, he warned, according to official transcripts of FDA meetings earlier this year.

"I feel that it is better in the long run to have a good vaccine or a better vaccine … than having just a potential (for protection)," Palese, director of microbiology at Mount Sinai School of Medicine in New York, told the FDA panel in March.

http://www.dailystar.com/star/today/31214NFLU-VACCINE-DEN.html
21 posted on 12/13/2003 11:37:10 PM PST by kdono
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To: DJtex
The transcript of the vaccine selection committee mentions signature changes at amino acid positions 155 and 156 in HA. The change of H155T actually involves two mutations (C463A and A464C). Interestingly, the same changes are found in pigs and ducks. They are also found in human isolates collected just after the 1968 Pandemic. The other change also involves two mutations to produce Q156H. In Fujian it is A468T and in the other Fujian-like isolates it is A468C. It looks like the virus was pretty serious about changing those two amino acids.

Unfortunately, I suspect the "signature" will be Peter Palese's vote on the science and everyone else's focus on expediency or cost cutting (using the same old Panama strain for the 4th year in a row).

I think it will be a VERY long winter.

24 posted on 12/14/2003 8:39:50 AM PST by kdono
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