H1N1 Vaccine in October, IF all goes well.(that is a big IF)

indigo girl · May 28, 2009

A very big if so far, but it will probably be necessary for the 2nd wave. I really do think so.

Here is an hour long video, taped in Philadelphia. Just a group of virologists, and science geeks or disease geeks if you will, getting together to chat about various diseases in the news, and recent science papers about them. They discuss CMV, West Nile, and of course, Swine flu. It's really very interesting. The guys in the podcast are incredible. You will learn much about viruses from them.

http://www.viddler.com/explore/csuspect/videos/51/

One topic that they did discuss was about a Swine Flu vaccine, and that an adjuvant to extend the doses is going to be used by one company here. I think Glaxo SmithKline? The FDA has not approved the use of this proprietary substance. They will need to get special permission to use the adjuvants in the US.

If the vaccine is approved, it will be the biggest clinical trial in history. That's right. Guess who the first participants will be? Let's hope that they get it right the first time. I hear that they have come along way since the 1976 fiasco though no one knows exactly what went wrong then.

oramar · May 28, 2009

A very big if so far, but it will probably be necessary for the 2nd wave. I really do think so.
Here is an hour long video, taped in Philadelphia. Just a group of virologists, and science geeks or disease geeks if you will, getting together to chat about various diseases in the news, and recent science papers about them. They discuss CMV, West Nile, and of course, Swine flu. It's really very interesting. The guys in the podcast are incredible. You will learn much about viruses from them.
http://www.viddler.com/explore/csuspect/videos/51/
One topic that they did discuss was about a Swine Flu vaccine, and that an adjuvant to extend the doses is going to be used by one company here. I think Glaxo SmithKline? The FDA has not approved the use of this proprietary substance. They will need to get special permission to use the adjuvants in the US.
If the vaccine is approved, it will be the biggest clinical trial in history. That's right. Guess who the first participants will be? Let's hope that they get it right the first time. I hear that they have come along way since the 1976 fiasco though no one knows exactly what went wrong then.

I can remember the vaccine distribution in Pittsburgh very well. There were two deaths at the center just a few blocks from my home. I mean I watched it happen. The people waiting in line were very medically fragile and they died from stress and anxiety. Remember, in 1976 elderly people could remember and had actually experienced the Spanish Flu and they were hysterical. In my opinion it wasn't the vaccine that caused the deaths that happened very close to the time the vaccine was administered. As for the other problems like GB, well that probably did have a link but I am not qualified to say it. Look it up, I am sure the situation is documented and medical people with better credentials than me were saying the vaccine was administered under very harsh conditions. Remembering that, I never take my mom to health dept flu clinics because she can't take those lines and that crush of bodies. I have gotten my flu shot there and felt stressed myself. Instead, we make an appointment at local pharmacy, walk in and get it and are out in 5 minutes. It is even less stress than going to docs office which would take longer. Yes, if they give out vaccines for H1N1 they should stay away from those flu shot clinics and those three hour waits. It raises the stress level in people who are already semi hysterical from news media reports.

Multicollinearity, BSN, RN · May 28, 2009

How would this vaccine be any more dangerous than our yearly influenza vaccines that contain different strains each year? I think I'm missing something.

indigo girl · May 29, 2009

No one is saying that it is dangerous. But, we are saying that adjuvants in influenza vaccines in the US have not been used before.

http://blogs.sciencemag.org/scienceinsider/2009/05/hhs-takes-1-bil.html

In countries outside of the United States, vaccine makers add a booster, or adjuvant, to increase potency, which increases the amount of final product they can make from a given amount of antigen—or reduces the number of doses ultimately needed to trigger a robust antibody response. Although the U.S. Food and Drug Administration (FDA) currently does not license the use of any influenza vaccines that contain adjuvants, it has approved adjuvant-containing vaccines against many other diseases.
HHS spokesperson Bill Hall told ScienceInsider that the money will purchase 20 million doses of vaccine, the amount needed to protect “critical infrastructure personnel and vulnerable populations.”
And Hall stressed that there has been “no decision” about whether to go into full-scale production to make enough vaccine for the entire country's 304 million people.

Maine17 · May 29, 2009

I read the link about adjuvants, but it did not state why the FDA has not approved the use of adjuvants with the influenza vaccines in the past. Does anyone know why?

indigo girl · May 29, 2009

Here is my take on it, but this is just my best guess, and does not reflect anything that I have read anywhere about this.

We never needed to use adjuvants before. Many doses of seasonal flu go unused because most people do not get vaccinated.

We now have a completely new situation. This is a novel flu virus, and there are many possible naive hosts globally. If the decision is made to go forward, and produce a vaccine, it will be in limited quantities, certainly not enough for everyone on the planet.

The link below describes an expermental vaccine made for one of the bird flu viruses, H9N2 that infected some children in Hong Kong in 1992. Like H5N1, bird flu, H9N2 is a virus with pandemic potential as it is another novel virus, and we would again be the possible naive hosts if infected.

As explained in the commentary, the seasonal flu vaccine contains 15 micrograms each of three different circulating flu strains of our seasonal influenzas-- much higher than the 3.75 micrograms of H9N2 flu virus contained in the lowest dose vaccine tested in this trial. It had been thought that protecting naive hosts to a novel virus might require two vaccinations. That is where the adjuvant comes in. Adjuvants increase immune response, and may dispense with the need for a second injection. As you can see in this trial, they were able to use much less than has been standard for each flu contained in your regular flu vax.

http://www.nih.gov/news/pr/sep2006/niaid-25b.htm

Maine17 · May 29, 2009

Thanks Indigo Girl for clarifying that info. It seems that we probably will have no choice but to go with adjuvants due to the need to make as much vaccine as possible (assuming the virus does not mutate). Wonder if this is something that the US should have been looking into to prepare for a pandemic. Makes me think that we are woefully unprepared to handle a significant event.

talaxandra · May 29, 2009

Australia's Commonwealth Serum Laboratories estimate they'll have a vaccine for H1N1 by August - link.

indigo girl · May 30, 2009

Australia's Commonwealth Serum Laboratories estimate they'll have a vaccine for H1N1 by August - link.

I would not bet on them vaccinating the first designated groups by August. Best estimates have always said 4 to 6 months, and then only in limited amounts. But, it does sound like they are moving forward with things, and they have not mentioned adjuvants either so this could mean two vaccinations instead of one. They may then find that those 10 million doses will only effectively immunize 5 million people.

We are at the beginning of June so 8 weeks away is almost August when they are "ready to manufacture" and THEN, they go to clinical trials. In the trials they have to figure out if it they are getting a good immune response, and make whatever adjustments that they need. So different groups of volunteers in the trials will probably receive different amounts of vaccine to see how little is needed to get an effective response.

It is going to be interesting to see what each of the vaccine manufacturers are going to do. This is history in the making, and I find it fascinating. We are going to be seeing different technologies used such as egg based versus cell based. We live in such interesting times!

http://money.ninemsn.com.au/article.aspx?id=819596

Pharmaceutical company CSL Ltd says it should have a swine flu vaccine ready for manufacture within eight weeks.
Batches of vaccine should start rolling out of CSL's Melbourne drug production facilities from late July, CSL Biotherapies general manager Mary Sontrop said.
The announcement comes after the US government placed a $US180 million ($A232 million) order for a CSL-made swine flu vaccine, and the federal government said it would obtain enough doses to provide cover for ten million Australians.
The vaccine antigen for A(H1N1) influenza would be made at CSL's facility at Parkville and would be tested in clinical trials funded by HSS.

talaxandra · Aug 5, 2009

Our vaccine began human testing two weeks ago (http://globalhealth.kff.org/Daily-Reports/2009/July/22/GH-072209-Swine-Flu.aspx); with hopes for a full roll out sooner than the 6-8 weeks initially planned (http://au.news.yahoo.com/a/-/latest/5778822/swine-flu-vaccine-may-be-out-early-govt/).

oramar · Aug 5, 2009

Our vaccine began human testing two weeks ago (http://globalhealth.kff.org/Daily-Reports/2009/July/22/GH-072209-Swine-Flu.aspx); with hopes for a full roll out sooner than the 6-8 weeks initially planned (http://au.news.yahoo.com/a/-/latest/5778822/swine-flu-vaccine-may-be-out-early-govt/).

Thanks, that is an interesting and informative link. Lot of good info in it.