Q? Do you plan to give the H1N1 Vax when it comes on the market?

[ha98ed14]

I have been thinking about this for weeks. When they come out with the vaccine, am I going to give it to DD? The testing will not be as thorough as other vaccines, including the regular seasonal flu, but apparently it is being mfg'd very much the way the seasonal flu vax is, so that is supposed to comfort people. But apparently in the 70s, there was a vax developed for an anticipated pandemic and it left some people really disabled. (I'm not exactly sure how; I heard it on NPR, and I'm too scared to look!)

I selectively vax'd, so I am not opposed to vaccines. I just worry about giving one that we don't know the history on because we have not had time to test it, but at the same time, this disease can be deadly. But so can regular flu and I did not give that last year. But I am particularly worried because this is the first year DD is in group daycare.

Anyway, my thoughts are muddled in the issue. What are yours?

[bubbaray]

I did a poll on this a while back: http://www.windsorpeak.com/vbulletin/showthread.php?t=328062&highlight=h1n1

I have since done some more research. The issue for me is adjuvants. The WHO has asked all countries and manufacturers to use "vaccine sparing methods" because the yields are so low, 1/10th that of seasonal flu vax's.

The Canadian gov't has flat-out admitted that it will be using adjuvants and GlaxoSmithKline's H1N1 vax uses its proprietary AS03 adjuvant. Novartis has a similar proprietary adjuvant as do all the other H1N1 vax manufacturers.

Apparently, the US FDA and CDC have not said whether they will or will not use adjuvants, but the "word" on the street is that they will pretty much have to because that is the vax that the manufacturers are producing, KWIM? Plus, the yields are so low, that is the only way to vax enough people to make a campaign feasible.

Adjuvants are typically used in vax's. Aluminum is one example. The role of an adjuvant is, AFAIK, to stimulate the immune system to give a more robust response and produce more antibodies. I understand that and am, in general terms, OK with the use of adjuvants as a proven methodology in vaccinations.

However, I am extremely concerned about the proprietary adjuvants that will be used with this particular vaccine. The GSK and Novartis adjuvants contain squalene. They have NOT been tested in children or adults under age 65. They have only been used in Europe (for a long time) in adults over age 65. Squalene was implicated in Gulf War Syndrome from anthrax vax's given to soldiers in the 1st GW.

The other issue for me is that squalene is typically derived from sharks livers. My DD#2 is anaphylactic to finned fish. Is she anaphylactic to shark? No one knows. I have calls into GSK and our public health nurse (nurse specialist who deals with my children b/c of her knowledge of allergies and vax's). The nurse called me back and left a message that my query has been escalated to our CDC -- will this vax be contraindicated for people who have fish allergy b/c of the use of squalene adjuvant? There ARE other sources (plant) of squalene, but sharks livers is the most common.

Bottom line, at this point, my DD#2 will NOT get the H1N1 vax. She IS now cleared to have the seasonal flu vax for the first time (she previously had a greater egg allergy than she has now -- she has specifically been cleared to have the flu vax this year). She will get the seasonal flu vax.

I'm not sure what I will do for DD#1 and myself. We both have asthma and DD#1 is probably at the greatest risk in our family for complications from the H1N1 flu. I'm really torn on this. I've seen her in the ER struggling to breathe in June. The docs and nurses there were really scrambling to stabilize her and it was really REALLY scary. I can't imagine a worse scenario (that was only from seasonal pollen allergies) where she has fever and other physical symptoms.

All of us will get the seasonal flu vax. I'm actually hoping that what I have now and the girls have just come down with is the H1N1 in its mild form. Sore throat, fever, cough, runny nose, aches, etc. We have pretty much all the symptoms.

[ha98ed14]

Thanks Melissa! My own tutorial. I have no clue what half those words mean, but at least I know what to look up! :)

[mecawa]

My girls will def. get the seasonal flu shot, and DD#2 will def. get the H1N1 vax, if available. DH will also get both seasonal and H1N1. DH has two severe underlying health problems, and the thought of him getting H1N1 scares me. It would not be good. DD#1 is extrememly healthy, I would actually consider her not even getting the seasonal one at all. DD#2 had a really rough year medically (10 weeks hospitalized, surgery,etc.) so she will be getting both, as it has been advised to me by her docs. I won't get one as long as (I won't qualify for either first of all) DD#2 and DH have them.

[tnrnchick74]

I too am torn. I think right now, having done more research, *I* am going to get the H1N1 vax because I have asthma and am a health care worker. Yeah, I work with babies, but we have had 3 Mom's with H1N1 who delivered recently.

As far as DS - I do not think I'm going to give him the H1N1 vax. I will be protected and won't be bringing it home. DS has milk allergies, but hasn't been exposed to eggs yet (besides cooked in bread,etc) and he didn't get a flu vax last year due to recurrent ear infections, colds.

If the H1N1 vax was exactly the same formulation (adjuncts, methadology, etc) as the seasonal flu, then I might consider it - but there are too many things that are different and the CDC is planning on releasing it before all trials are completed. That scares me a little.

[DebbieJ]

No way in you-know-where we'll be doing that shot. We don't do the regular flu shot either.

[bubbaray]

As far as DS - I do not think I'm going to give him the H1N1 vax. I will be protected and won't be bringing it home. DS has milk allergies, but hasn't been exposed to eggs yet (besides cooked in bread,etc) and he didn't get a flu vax last year due to recurrent ear infections, colds.


You might want to ask your DS' allergist about this. My girls' allergist says that as long as a child can tolerate hidden egg (in baking, etc), they are fine to have the flu shot (seasonal/H1N1) as the amount of albumin is very small.

As far as the "creation" of the H1N1 vax, it is being made in the same way as seasonal flu vax -- cultured in eggs. IIRC, it is actually a dual vax that is partially made from the SARS vax from the last pandemic (2005?). The adjunct issue is as set out in my post above. If I was in the US, I'd be more than a little perturbed that the FDA doesn't seem to want to disclose the adjuvant issue "transparently", possibly b/c of the squalene/Gulf War Syndrome possible link. I dunno. I highly doubt ANY country will be able to access non-adjuvant H1N1 vax b/c there are only a limited number of co's making the stuff and they are all being reported here to be fully intending on using their proprietary adjuvant -- and the yields are low for all the companies too. Its kinda like a mass-trial. If I was a pharma co, I'd be pretty happy -- I get a free human trial. On the whole planet, all age groups, etc..

[scrooks]

I've been thinking about this as well and I don't know what I will do. DD has had all her vacs and gets an annual flu shot so she will get that for sure. DS will be born in Sept. He will be too small to get either flu shot (DD was a July baby and got her first flu shot when she was 6 months old). I don't want DD to bring H1N1 home but I don't want her to be exposed to a potentially dangerous vaccine either. Since DS will be small we probably won't be leaving the house much this winter so I am thinking the risk will be lower for us....I don't know if this is good logic.

[SnuggleBuggles]

Melissa, that was great information- thank you!

I do not plan to get the vaccine for anyone in the family b/c of the newness of it...and what Melissa said.

Beth

[1964pandora]

I believe that we had the swine flu a couple of weeks ago. It was widespread in Virginia and supposedly it was the only thing that was in major circulation. I have a 4 year old and a 3 year old. They felt really awful for about 36 hours. My husband and I had flu symptoms for about the same period of time. Basically, we were all just completely exhausted with fevers. It was really nothing for us compared to what I thought it would be and I'm glad that we got it.

P.S. Oh, my 3 year old threw up several times, but that is supposedly the way it can affect the very young.

[tnrnchick74]

You might want to ask your DS' allergist about this. My girls' allergist says that as long as a child can tolerate hidden egg (in baking, etc), they are fine to have the flu shot (seasonal/H1N1) as the amount of albumin is very small.

..

As far as the allergist is concerned, he can get the flu vax...and I was planning on getting the flu vax for him this year (since he was so young) but he kept getting sick and I refuse to vax when sick...even with "just" a flu vax. But the other reasons are why I'm not going to give the vax to him - the proprietary adjuvents that MAY be safe, and MAY cause a reaction in my kiddo who's proven to be allergic-prone.

Me, yeah - I was military and I've had a lot of "experimental" vax's...I will go ahead and get it because I'm at the greatest risk for encountering the h1n1

[brittone2]

No.

On a separate note I saw somewhere recently some commentary that this year's seasonal flu shot is likely not a good match to what is/will be circulating. Forget where I read it though.

[daisymommy]

You couldn't pay me enough to vaccinate myself or my kids with anything that has only been tested for several weeks, and we have no idea the long term possible reactions...such as death with the last time we rushed a vaccine through.

[shawnandangel]

They are doing some of the trials for the vax here in Nashville. So far so good. It's been on the news a few times.

I will be getting the shot for several reasons. I am in the high priority category 3 times. I am an adult in the 0-24 age bracket, I am a caregiver to a young child, and I go to nursing school.

DD will be getting the shot based on my ped's recommendations. She will for sure get the normal flu vax.

Just a quick question for Tnrnchick - You said you wouldn't be bringing the flu home to your DC because you will have the vax. Not to contradict you but can you not still bring home the flu germs? You may not get the flu but your DC may. Correct me if I'm wrong on this. If you're like me though - when I was working in the hospital before DD was born I would take off my hospital shoes before entering the house - carry them to a box, take off my scrubs and take a shower before I even sat down on my couch. I was so afraid of bringing home something.

[firsttimemama]

Most likely we will not get the shot.

[wellyes]

I don't think so, unless we have specific reason to be concerned about H1N1 in our area or a strong recommendation from our ped. We don't usually bother with flu shots either.

[tnrnchick74]

Just a quick question for Tnrnchick - You said you wouldn't be bringing the flu home to your DC because you will have the vax. Not to contradict you but can you not still bring home the flu germs? You may not get the flu but your DC may. Correct me if I'm wrong on this. If you're like me though - when I was working in the hospital before DD was born I would take off my hospital shoes before entering the house - carry them to a box, take off my scrubs and take a shower before I even sat down on my couch. I was so afraid of bringing home something.

Sure, its possible. But the greatest risk would be for ME to get H1N1 and then infect my son. I work in an NICU - we do a surgical scrub before/after shift. I change clothes as SOON as I get home, don't wear work shoes in the house, take shower immediately. As long as I follow strict (and basic) hygeine protocols, then I'm reducing the risk of passive transmission greatly. MY biggest fear is getting sick with H1N1 and then my son getting it from me.

I'm just not comfortable exposing my son to a vax that hasn't been "proven" as safe for many years.

[icunurse]

I really don't want to get the vax, but my job is really pushing it. I work in an adult ICU, so we have been getting possible H1N1 cases since they first started being diagnosed. While we use isolation precautions, it's not worth the risk. But I am also not crazy about the vax not being tested for a while. While it *should* be safe if manufactured the same way as the flu shots, I would personally feel better if it wasn't rushed to be made.

My biggest concern is for the kids. Both attend school or MDO and word on the street among the infectious disease docs is that flu season is going to be very, very bad this year. Not sure how much the vax will cover us if the H1N1 mutates a bit, but, if it does like the 1918 pandemic, it struck the healthiest/youngest people the most. Reports already state that the biggest risks are pregnant women, women who have recently given birth, caretakens of young children and elderly, and healthcare workers.

I am hoping to catch one of the infectious disease docs (who is pretty conservative) and see what he's doing with his own kids. Then, I'll take the info into consideration :)

[justlearning]

Because our 3 year-old is undergoing treatment for cancer (and thus immune suppressed), we will all get the vaccination as soon as it's available. Also, DH is a family practice physician so he'll likely be treating patients with H1N1. So for us so there's no question about whether or not we'll get the vaccine as well as the regular flu shots.

[bubbaray]

I don't have my sources here (they are at work and many of them are from publications I can't access at home).

From Google I found: http://www.allamericanpatriots.com/48752430-hhs-purchases-glaxosmithkline%E2%80%99s-a-h1n1-swine-flu-influenza-antigen-and-proprieta

http://www.who.int/vaccine_research/documents/Brief_overview_of_use_of_oil-in-water_emulsions.pdf -- overview, last page talks about GWS. Discusses differences between the three major manufacturers.

http://www.who.int/vaccine_research/documents/Report_on_consultation_on_adjuvant_safety_2.pdf
Some concern were raised on the use of squalene-containing adjuvants in all age groups, due to limited experience with these products in children. These adjuvants must therefore be introduced carefully into these groups. In particular there are no data at all on the safety of squalene adjuvanted
vaccines in the very young (under 6 months).

http://www.wikidoc.org/index.php/Immunologic_adjuvant

http://www.wikidoc.org/index.php/Gulf_War_syndrome
Data linking squalene (http://www.windsorpeak.com/index.php/Squalene) in the vaccine to Gulf War Syndrome was "presented in the peer-reviewed February 2000 and August 2002 articles. The published findings (1) strongly suggest that the GWI-like illness being reported by all of the various patient groups is the same illness, (2) strongly suggest that the contaminated vaccine caused the illness in the AVIP group, and (3) further suggest that squalene contamination of one or more 1990-1991-era vaccines accounts for the GWI cases from that era." [13] (http://www.autoimmune.com/GWSGen.html) The sickest veterans tended to have the highest levels of squalene antibodies in their bloodstream. [14] (http://www.gulfwarvets.com/insight4.htm)
Even after the war, troops that had never been deployed overseas, after receiving the anthrax vaccine, developed symptoms similar to those of Gulf War Syndrome. The Pentagon failed to report to Congress 20,000 cases where soldiers were hospitalized after receiving the vaccine between 1998 and 2000. [15] (http://www.vermontguardian.com/dailies/122005/1220.shtml)
252 Members of a U.S. Air Force Squadron who received the vaccine were surveyed, and 139 of these returned their questionnaires. Of these, 58% reported reactions, often consistent with some features of a Gulf War Syndrome type illness, including: joint and muscle pain (41%), decreased energy and tiredness (29%), reduced concentration (28%), short-term memory loss (24%), and sleep problems (17%). [16] (http://www.gulfwarvets.com/survey.htm)
In 2000, a medical examiner ruled that anthrax vaccine was a contributing factor in the death of a civilian who helped manufacture the vaccine given to U.S. troops. [17] (http://www.gulfwarvets.com/death2.htm) That same year, a Canadian judge ruled that the anthrax vaccine was potentially unsafe, halting the trial of a soldier who had been court-martialled for refusing to take it. [18] (http://www.gulfwarvets.com/can.htm)
Despite repeated assurances that the vaccine was safe and necessary, a U.S. Federal Judge ruled that there was good cause to believe it was harmful, and he ordered the Pentagon to stop administering it in October 2004. [19] (http://www.marinecorpstimes.com/story.php?f=1-292925-1412120.php) That ban has not been lifted. Anthrax vaccine is the only substance suspected in Gulf War syndrome to which forced exposure has since been banned to protect troops from it.
In July 2005, a U.S. soldier was awarded a disability pension for medical problems which developed after his anthrax vaccination, after a Federal Appeals Court ruled in his favor. [20] (http://www.gulfwarvets.com/anthrax_courtdecision.htm)
On December 15, 2005, the Food and Drug Administration, released a Final Order finding that anthrax vaccine is safe and effective. [21] (http://www.anthrax.osd.mil/resource/qna/qaAll.asp?cID=294) All vaccines cause adverse events in a subset of those to whom they are administered. [22] (http://www.nap.edu/catalog/10310.html), [23] (http://www.anthrax.mil/resource/qna/qaAll.asp?cID=303) Women who receive the vaccine get pregnant and deliver children at the same rates as unvaccinated women. [24] (http://www.anthrax.mil/resource/qna/qaAll.asp?cID=321) Anthrax vaccination has no effect on pregnancy and birth rates or adverse birth outcomes. [25] (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11911758&query_hl=9&itool=pubmed_docsum)
Note: the anthrax vaccine used in the early 1990s was different than the vaccine approved for use today. [26] (http://www1.va.gov/rac-gwvi/docs/Minutes_Dec2005_Text.pdf)

http://www.wikidoc.org/index.php/Squalene -- overview of what squalene is and: A study linking squalene, as experimental vaccine adjuvant, to individuals with the clinical signs of Gulf War syndrome (http://www.windsorpeak.com/index.php/Gulf_War_syndrome) was published in 2002. The published findings strongly suggest that the squalene contaminated vaccines could be responsible for the Gulf War Syndrome symptoms seen in the study group, and recommended that a large scale epidemiological study be performed to verify or correct this.[3] (http://www.windsorpeak.com/vbulletin/#_note-2) Despite repeated assurances that the vaccine was safe and necessary, a U.S. Federal Judge ruled that there was good cause to believe it was harmful, and he ordered the Pentagon to stop administering it in October 2004. [4] (http://www.windsorpeak.com/vbulletin/#_note-3)

[bubbaray]

And more:


http://www.theglobeandmail.com/life/additives-could-stretch-vaccines-but-complicate-fast-track-planning/article1234480/
For that reason, officials in the U.S. have hinted they would rather not use adjuvants, unless the compounds are needed to ensure adequate supply for Americans. With manufacturers complaining of low yields as they attempt to make the new vaccine, that need remains a possibility, officials admit.

Canada will likely take a different approach. The head of the Public Health Agency of Canada, David Butler-Jones, has said Canada will use adjuvanted vaccine in response to a call from the World Health Organization to stretch the limited global vaccine supplies.

http://www.theglobeandmail.com/news/national/20-per-cent-of-canadas-flu-vaccine-headed-to-developing-nations/article1227827/
GSK said Wednesday an adjuvanted vaccine is in production. Adjuvants are chemical additives that improve the immune response so less vaccine is needed. That means the company could produce vaccines using less seed stock, which is important given the low yield to date. GSK plans to use an adjuvant system called AS03.

But there are no adjuvanted vaccines in Canada, so it would require a new licence and more clinical trials, making mass production more complicated.


AFAIK, all of the vaccine manufacturers who are making H1N1 vax are using proprietary adjuvants. GSK, Novartis and Sanofli-Pasteur are all listed as using proprietary adjuvants containing squalene.

[gatorsmom]

Regular flu shots- yes.

The H1N1 shots- I'm not sure. I don't like that it's being rushed through production. Makes me nervous. Of course, NOT getting the shot makes me nervous too. If none of my children were in school, I"d definitely not get it. BUT with 2 boys in school who could bring it home to the twins, that scares me.

Cha Cha was really sick back in May and the ped really thought he had the H1N1 flu. I was hoping he did and that he could pass it to the other kids because the ped commented that the summer forms of it have been pretty mild and she and her colleagues think that having it this summer will make you immune for the fall version. Unfortunately, Cha Cha didn't have it. But it was a nice thought.

[Twoboos]

I don't think so. DDs have never had the regular flu shot, and neither did I even when pregnant. Because it's so new, and the regular flu shot never seems to be "on target" to get the right strain IMO, we'll probably pass unless it turns out our area becomes super-high-risk or something.

[Clarity]

I'm not sure. I've never had the flu before, ever and dh doesn't think he has before either. I hope that means we have some strong natural defenses. I will have both kids vax'd with the "regular" flu shot and I will weigh the advice of my pediatrician with what else I learn once the shot becomes available. They definitely won't be in the first wave, anyhow.

[alexsmommy]

I am HORRIBLY torn on this issue.
I am pregnant and completely freaked out about the increased risks and how severe it seems to present in pregnant women. DS1 was a preemie and seeing these stories of babies having to be delivered early freaks. me. out.
DS1 has had regular flu morph into pnuemonia so severe he was hospitalized 2x and required surgery for a chest tube and came home on PICC line abx.
I am in denial that I have to get going on researching and making a decision. My gut reaction is that we will get it. We do get the regular flu vax each year and I am comfortable with that decision and my initial statement to people was that I would get it. Then as I started thinking about it - I semi-delay vax (no more than one shot at a time) and I have refused new vaxes - I want time to see what the effects are. The idea of a "new" vax with the potential of lots of additives while pregnant is starting to give me the heebie-jeebies. I don't like the idea of them in my son either.
My midwife tends to be very lax/supportive of individual choice about things, and she was very, very clear that she'd prefer I get it so that weighs in decision making process. I totally trust her.
Sigh.

[KBecks]

I believe that we had the swine flu a couple of weeks ago. It was widespread in Virginia and supposedly it was the only thing that was in major circulation. I have a 4 year old and a 3 year old. They felt really awful for about 36 hours. My husband and I had flu symptoms for about the same period of time. Basically, we were all just completely exhausted with fevers. It was really nothing for us compared to what I thought it would be and I'm glad that we got it.

P.S. Oh, my 3 year old threw up several times, but that is supposedly the way it can affect the very young.

I think we may have had it already, goodness knows we get EVERYTHING that goes around. We are lucky to be pretty healthy to begin with, so we will not get the vaccine and I hope we would get through the flu without severe complications if we should get it. We do not do the seasonal flu shot either.
I hope to be more vigilant about hygiene and handwashing with the boys and also have everyone eating healthfully.

[tnrnchick74]

I am HORRIBLY torn on this issue.
I am pregnant and completely freaked out about the increased risks and how severe it seems to present in pregnant women. DS1 was a preemie and seeing these stories of babies having to be delivered early freaks. me. out.
DS1 has had regular flu morph into pnuemonia so severe he was hospitalized 2x and required surgery for a chest tube and came home on PICC line abx.
[rest of post snipped for brevity]
Sigh.

If your situation was me, then I would feel that the potential benefits outweigh the potential risks. If DS had been a preemie, or had lung issues of any kind I would get both the seasonal flu & h1n1 vax for him. As it is, we are lucky. *I* will get both, but he will only get the seasonal flu. At least that's my decision right this second...

[alexsmommy]

If your situation was me, then I would feel that the potential benefits outweigh the potential risks. If DS had been a preemie, or had lung issues of any kind I would get both the seasonal flu & h1n1 vax for him. As it is, we are lucky. *I* will get both, but he will only get the seasonal flu. At least that's my decision right this second...


Your last sentence made me smile.
80-90% of the time I agree, it seems like a no brainer. But then this voice starts up in my head...
I'm pretty sure my ped - who is very laid back, will look at me like I have two heads as will my midwife if I told them I was wavering. I really do trust them and pray my only hospital time this winter is delivering so the benefits vs risks are looming large in my mind.

It is nice to hear a NICU nurse say this - I appreciate the feedback.

[bubbaray]

SARS was fresh in the picture here when I was PG with DD#2, so I completely understand where you are coming from. If I were PG, I would get the H1N1 vax for myself. One of those articles I linked to (one of the WHO ones) talks about squalene vax's being safe for PG woment. It seems to be children where there is no data.

GL!