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H1N1 Vaccine (swine flu)
- Jul 30, 2009 at 9:37 AM
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- Comments (29) Total Views (1226) Everyone can see this journal post.
The time has come to discuss the H1N1/swine flu vaccine that is currently in manufacture around the world. It is expected the vaccines will be ready to use beginning in September, with large quantities available in late October. I have had a few people come to me with questions about this vaccine, so I'll tell you what I know, with a little bit of my personal opinion thrown in.
Most of what I have been able to find on this subject comes from media reports, but I have been able to use some personal knowledge of the subject, along with the manufacturer's websites to fill in some holes. I hope you find this post useful and let me know if youhave any questions. This post really isn't open for debate on the safety or efficacy of vaccines in general, so I hope we can stick to the subject at hand - the new vaccine many of you will be offered (for yourselves or your kids) in the coming months.
I have been able to find (through the news) four manufacturers of the H1N1 vaccine: Novartis, Glaxxo-Smith-Kline (GSK), Baxter, and Sanofi Pasteur. Of these four, only Novartis has so far produced their first batch, and others are in pre-production preparations, such as finishing up previous seasonal flu vaccine activies, preparing protocols and supplies, etc. Sanofi has already stated their manufacturing runs will be a bit behind the others, so the supply will be available late September (or possibly later). Overall, between the multiple manufacturers, the USA expects to have about 40 million doses available in September, and 120 million more doses available in late October. Because of this supply bump, the decision has been made to offer the vaccine to certain high-risk groups initially, and then open up to other groups at a later date, depending on availability. The CDC has also reserved the right to change the groups offered based on supply, in case a manufacturing run fails or is otherwise unusable, thus shortening the supply.
It seems though, that timing is a critical factor. The CDC expects the incidence of H1N1 flu to increase dramatically in the fall as kids return to school, and even more in the winter as flu virus sees its highest incidence in general. Since the vaccine is only protective of an individual if administered before they are infected with the natural virus, it would be ideal (from a vaccination timing standpoint) to have the vaccinations start ASAP, but preferablly no later than October-ish, before winter really hits.
The problem with this is that the flu vaccine takes time to manufacture - a couple months! The manufacturing issue is compounded by the fact that this virus would need to be adapted to grow in eggs (the standard protocol for seasonal flu vaccines) before manufacturing on large scale could even begin. At least one company has gotten around this by growing the virus in live cells (I decline to identify whch one since I am not sure this is public knowledge), greatly reducing the time-to-manufacture since they don't have to bother with adapting the virus to grow in eggs. But then a second manufacturing problem has been identified - the procedure (whetehr grown in eggs or cells) does not produce the quantity of antigen they are accustomed to getting. the yield seems to be half the norm, so they will be able to produce a lower number of doses from the same starting material. Not a deal-breaker, but definately something they need to consider when estimating supply. They may be able to increse its activity by using adjuvants, or requiring multiple doses, so these types of changes to the protocol are being researched and should be identified soon.
The obvious questions consumers will have are: Is it safe? Is it going to work? Is it the same as the seasonal flu vaccine? I'll do my best to answer these questions for you here.
Is it safe? The FDA is looking into that by requiring clinical trials, which has been "fast-tracked" because the would like to know as much as they can before they start to vaccinate the entire population. They acknowledge they will not have all the data analyzed by time the vaccinations start, but they probablly don't need to. The flu vaccines in general have been used for decades, and there is no reason to believe this would be *much* different. There are trials going on all over the world, and they are at different stages. From what I have heard, there have been no issues with phase 1 trials (safety), and at least one manufacturer has progressed to phase 2 trials (efficacy). Check one an example of the clinical trial information here.
Is it going to work? It should. And they are working through phase 2 trials tomake sure. As stated, flu vaccines have been used for a long time, and they are known to work against the specific virus they are designed against. The question with this one, since it is being rushed through, is if they have the dose worked out to perfection. Perfection is not necessary a requirement, as long as they understand the limitations of the vaccine, they can work with it (by making adjustments to the formulation by adding adjuvants or by requiring additional doses like they do with varicella vaccines).
Is it the same as the seasonal flu vaccine? Functionally it is the same. A dead virus (usually) is in the vaccine, and once in your body it causes an immune response which builds your antibodies against the virus. If your body gets infected with the virus later, your antibodies will kick into overdrive and take care of the virus before it gets much of a chance to hurt you. The H1N1 flu vaccine may be a bit different in that at least one manufacturer will be using live cells to grow the virus instead of using eggs to grow it. This in itself isn't much of a concern because they use live cells to produce virus and proteins for other vaccines (meaning this is not an entirely new technology). In additio, it appears most of the vaccines will be injectables, but some may be nasal inhalants. This is where my opinion comes in - I prefer the injectables since they have been used for many years, and the nasal inhalants are a more recent FDA approval (for seasonal flu). The are doing clincal trials for both types, though.
Should you get the vaccine if offered? You really need to discuss this with your doctor. You need to determine what your comfort level is with vaccines in general, whether you are at risk for getting a serious disease if you do have viral contact, and your chances for viral contact. Weigh these issues against possible vaccine reactions (in general), and your concern for the "rush" clinical trials and manufacturing. I haven't made my decision yet. I am leaning towards NO at this time, because I am not convinced the H1N1 pandemic will be severe, but that is just my guess. I do feel I have the luxury to wait and see ow the southern hemisphere progresss through their flu season (it is winter there now).
If you need some background on the H1N1 flu, see this past post.
Let me know if you have questions (feel free to message me or post below). I am here to help you understand the science, so you can make an informed decision for you and your family. I will never try to convince you to do anything, other than understand the science.
Tonya
AKA sunmoonstars
Comments:
Hi! So, I updated the post a bit to say "usually dead", since it looks like the majority are dead, but some are live, but inactivated. Good catch.
Why wouldn't it be safe? We have no reason to believe it won't be. So the "fast track" seems like a good idea, for the sake of time, understanding the risk of a problem to be low.
Will the ingredients be the same? not exactly. most people consider the "leftover trace amounts" of components from the cell culture medium to be part of the "ingredients" list, so minute quanitites of salts, amino acids, vitamins, etc, from the medium may be there (trace levels). These types of carry-over components will be very similar to other vaccines that are made using live cells (instead of eggs).
So, if you think of this new vx as a cross between the current flu vax they make in eggs, and other vax they make in cells..... we have safety and efficacy data from those two product types they can use to justify the use of this new vaccine.
A little freaked out? I hear ya, and that's why I lean towards NO, myself (for now). Anything new is a bit scary. We won't know more about the composition until they release the product (and product insert). I'll keep up on this for you a bit...and update when they start using it (or other news comes up).
Given that we have the luxury of watching how the southern hemisphere proceeds with their flu season, why is the CDC hyping this up so much? Is it just so that we will be prepared for a possible onslaught of H1N1?
They are not touching me or my family with that thing. No thank you!
comfy - I am not sure the CDC is doing the hyping - I think it is more the media playing on people's fears.
The CDC is doing what they are supposed to - assess the situation and act if necessary.
I personally am not sure the government buying millions of doses of vaccine many people won't use is the action I would want. But no one can see into the future of they are "saving millions from certain death" or "wasting money on reducing a risk that is already incredibly low".
I'm pretty terrified both ways! I'm pregnant, and according to the news, we are number one on the list and for good reason. The mortality rate for h1n1 for pregnant women is higher than the general public plus it causes preterm labor and such. So, I'm terrified to get the flu. But I am also terrified of putting a practically untested vaccine in my body. In general I don't do flu shots but I don't know. I guess whoever it is behind the hype and fear mongering is doing a good job.
This is very informative.
I would like to point out that the last swine flu vaccine killed and paralyzed so many people that the director of the CDC at the time resigned and apologized. He said they did the best they could at the time with the knowledge they have.
Since you stated that this vaccine is functionally not that different than the ones in the past, I would like to know what they are doing to prevent this one from killing and paralyzing people. Especially since they are "fast tracking" the clinical trial.
Debbie - my suggestion to you is prevention. Get a good grip on basic disease prevention - cleanliness, no eye touching, stay away from crowded places with sick people, and teach your kids the same. As I am TTC, this is likely the route I will take, as well.
Good article! I counted it popular!
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This Pennsylvania mom of three is a big fan of the band The Cranberries, loves to eat seafood and enjoys spending time with her family at Knoebel's amusement park.
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