From Flu Wiki 2

Forum: Vaccine 3

31 July 2006

anon_22 – at 16:57

Continued from part 2

anon_22 – at 17:04

Last post:

Leo7 – at 17:01 Anon 22:

“The FDA, by refusing to acknowledge that, may risk landing the vast majority of the US population with no pandemic vaccine at all. “

Am in full agreement with you but especially on the last line. But, I am afraid that with all the various vaccines out and about in many countries—we may get something totally unexpected. I would hope we would be told this is the UK or Chinese vaccine and not lump all of them into the Pandemic flu vaccine category.

Dude – at 17:08

I think it will be a little like the Army when I got my shots. Shutup, lineup, rollup and take what we got.

ANON-YYZ – at 17:11

In the news thread today, there is reference to Indonesia having their own ‘special vaccine’. If a human vaccine is ‘bad’, could it result in ‘asymptomatic human carriers’, like poultry in South China. What would it mean if that happens.

anon_22 – at 17:14

Leo7,

I may not be understanding you correctly. I don’t think there is any indication that the Chinese is making a human H5N1 vaccine. They may be working on it quietly, we just don’t have any information. What we have seen in press are all related to poultry vaccines only.

The other issue is any vaccine produced outside of your country of residence, in your case the US, may not be available to you at all because when a pandemic starts, there will be huge political pressure for vaccine-producing countries to stop exporting any vaccines until their population is all vaccinated, irrespective of prior contracts or promises.

It doesn’t matter whether its the UK or China or France. The considerations will always be their own citizens first. The US government will be no different, but since the US normally exports none or negligible amounts of flu vaccine, they won’t have to make those decisions.

So the only people on this planet with a remote possibility of having access to a pandemic vaccine will be citizens of countries with current vaccine production facilities. And even so, there won’t be anywhere near enough unless substantial trade-offs in efficacy and/or safety are made.

As I said, these are very harsh realities. No one likes them. And, currently, even such bad solutions are still some ways off from becoming realistic.

Come a pandemic, there will be angry recriminations and conflicts of interest and fights over who gets what and why and who says.

It’s what keeps me awake nights… <sigh>

Dude – at 17:15

What did they say in Armageddon: “About the scariest thing imaginable…”

anon_22 – at 17:18

ANON-YYZ,

There is no indication that Indonesia has the capability to make a human pandemic vaccine.

And they can’t really do it quietly cos they have to depend on outside assistance to make the seed strain ie make the H5N1 safe, before they can make a vaccine. Currently that is the job of the WHO, who therefore knows exactly which companies in which countries are working on that.

China might have the ability to do it on their own, I don’t know. Indonesia won’t.

ANON-YYZ – at 17:25

anon_22 – at 17:18

So what’s this then:

“The Indonesian government plans to produce typical bird flu vaccine designed for Indonesian people as death toll has leveled the world’s highest, the health minister said Monday. “

http://tinyurl.com/ofcqx

Are they making it up to soothe the public, or foreigners?

anon_22 – at 17:31

I know, I read that. It is either BS, PR, or I’m mistaken.

FrenchieGirlat 17:48

anon_22 – at 17:14 — “The other issue is any vaccine produced outside of your country of residence, in your case the US, may not be available to you at all because when a pandemic starts, there will be huge political pressure for vaccine-producing countries to stop exporting any vaccines until their population is all vaccinated, irrespective of prior contracts or promises.”

May I suggest that would be the biggest ever human clinical trial, at least for the short-term consequences?

anon_22 – at 17:55

Frenchie,

Of course you are right. :-(

FrenchieGirlat 18:15

If Indonesia is actually manufacturing their own vaccine for only their own people, as per the article quoted, thereby making the first nationwide clinical trial, shall I dare say they called it on themselves, and perhaps owe it to the rest of mankind… Or is this too harsh?

anon_22 – at 19:02

They can’t make their own vaccines. We know they don’t have vaccine production capacity. Unless you are talking about using poultry vaccines for people. It will be the height of craziness to do that, but then that’s just me.

Leo7 – at 19:14

Anon 22:

You are right of course, I was tripping out, no one will share vaccines with the US, (Just me guessing). I remember some articles where it was stated they might have to use poultry vaccines on people. I will try to find the links.

Leo7 – at 19:18

Here is one example where it’s been considered. http://tinyurl.com/fqw4w

anon_22 – at 23:22

Leo7,

Thanks for that article. Yes, Stohr spoke about that in London, that in theory one can make use of the enormous capacity to generate antigens that agricultural vaccine manufacturers such as the Chinese have. But when I asked him to elaborate on the chances of success, he was however pretty pessimistic that the ‘downstream bottleneck’ problems cannot be overcome. Probably because of the huge difference in standards for purification and standardisation for human vs poultry vaccines.

Fedson’s point in the article is also worth noting, that something that looks good in principle, such as making more live attenuated vaccines, can be very difficult in practice when you are considering the scale ie the number of doses needed when compared to seasonal use. One just cannot make those amounts with existing approved processes eg Flumist, and any variation eg changing into nose drops will require re-registration as a new product (and rightly so for safety reasons) which will take a very long time.

Melanie – at 23:24

anon_22,

I take it that you are pessimistic on the treatment side? (Just moving this discussion into layman’s language.)

anon_22 – at 23:32

An excellent wake-up call from David Fedson on pandemic vaccine Vaccine Development for an Imminent Pandemic: Why We Should Worry, What We Must Do

Abstract:

The avian H5N1 virus continues to evolve and poses an imminent pandemic threat. Pandemic vaccine development, however, has progressed slowly. For it to succeed, it must be based on a public health perspective that reflects the arithmetic of pandemic vaccine demand, especially by countries without vaccine companies. Clinical trials of H5N1 vaccines have been discouraging, and we must understand why the H5N1 virus is so poorly immunogenic. Antigen-sparing pandemic vaccines will be required, and future trials must identify the most effective adjuvant and determine whether whole virus vaccines will be needed. Problems related to intellectual property and concerns about several regulatory issues must be resolved. Public funding for clinical trials must be provided and firm leadership and coordination exercised by national and international (WHO) public health officials. Vaccination for an imminent pandemic requires a global perspective not only for vaccine development but also for vaccine production and distribution.

anon_22 – at 23:34

Melanie – at 23:24 “‘’anon_22,

I take it that you are pessimistic on the treatment side? (Just moving this discussion into layman’s language.)’‘“

If you are talking about antivirals, I’m actually very optimistic about tamiflu being life-saving, but only when given early and in large doses.

So the problem is not the treatment, but the availability and timely access and correct diagnosis.

Melanie – at 23:36

anon_22,

So, we’re screwed for anything in the short term?

anon_22 – at 23:39

Depending on what specifically you are talking about. Vaccine availability? Absolutely screwed!

Tamiflu and Relenza, well, ok for those who have them.

That’s why I am so keen on the idea of statins. The world needs a low-cost widely available solution even if it is not the optimum solution.

Melanie – at 23:43

06 August 2006

jessica R – at 20:43

“BARDA=“Biomedical Advanced Research and Development Agency (BARDA), that would act “as the single point of authority” to promote advanced research and development of drugs and vaccines in response to bioterrorism and natural disease outbreaks, while shielding the agency from public Freedom of Information Act (FOIA) requests. BARDA would be exempt from long-standing open records and meetings laws that apply to most government departments…”

How can there be a debate about vaccines if all the information does not need to be disclosed? I now understand Roman’s posts. It’s a shame he was banned.

Bronco Bill – at 21:00

jessica R – at 20:43 --- Has the BARDA bill, Senate Bill 1873, been passed? The most I can find on any government website is that it was last considered almost a year ago and placed on calendar, but no further action.

Bronco Bill – at 21:01

Looks like the next action possible will occur on Sept 5, 2006.

ANON-YYZ – at 21:04

Bronco Bill – at 21:00

Please check vaccineII (link on top of this page)

31 July 2006 Grace RN – at 11:44

Bronco Bill – at 21:16

BARDA has not been passed yet. Full Senate and House vote is next month.

07 August 2006

FrenchieGirlat 04:21

This article in Der Spiegel may be old (26 October 2005), but it does have a good description of the making of a vaccine by the Dresden firm, Sächsischen Serumwerke (Saxon Serum Works). Hatching Bird Flu Vaccine from an Egg. Despite the fact that the article is good, beware, the picture of egg inoculation is a badly chosen one, the girl does it bare-handedly and no PPE protection…

08 August 2006

stillwaggon – at 11:48

HHS issued a Request for Proposal for:

“Adaptation [retrofitting] of existing manufacturing facilities [in the U.S.]… to close the gap between current pandemic influenza vaccine supply and the stated HHS goal of 600 million doses of pandemic vaccine within six (6) months of the declaration of an influenza pandemic.”

Full RFP at:

http://fs2.fbo.gov/EPSData/HHS/Synopses/37271/DHHS-ORDC-VB-06-07/RFP06-07.doc

10 August 2006

anon_22 – at 01:31

14 October 2006

Closed - Bronco Bill – at 21:33

Closed to maintain Forum speed.

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