Four Swine Flu Vaccines Approved by FDA
Friday, September 18, 2009
Sanofi Pasteur's injected vaccine: Approved for ALL age groups (infants 6 months of age through adulthood and the elderly). It comes in several forms:
- Prefilled single ½ dose syringe with NO mercury - for infants 6 thru 35 months of age. Prefilled single full dose syringe with NO mercury - for anyone 3 years and older.
- Single-dose (full-dose) vial with NO mercury - for anyone 3 years and older.
- Multidose bottle (contains ten full doses or twenty ½ doses) WITH 25 mcg of mercury per full dose - for anyone 6 months and older (infants 6 to 35 months would get a half dose (0.25 ml), 3 years and older would get the full 0.5 ml dose).
Other ingredients include: the viral proteins, egg proteins, gelatin, formaldehyde, polyethylene glycol p-isooctyphenyl ether, sucrose.
CSL's injected vaccine: Approved for anyone 18 years and older. It comes in two forms:
- Prefilled single-dose syringe with NO mercury.
- Multidose bottle with ten doses WITH 24.5 mcg of mercury per dose.
Other ingredients include: the viral proteins, sodium chloride, sodium phosphate, potassium phosphate, calcium, taurodeoxycholate, egg protein, 2 antibiotics, and beta-propiolactone.
Novartis's injected vaccine: Approved for anyone 4 years and older. It comes in two forms:
- Prefilled single-dose syringes with a trace amount of mercury (less than 1 mcg because 99% of it is filtered out).
- Multidose bottle with ten doses WITH 25 mcg of mercury per dose.
Other ingredients include: the viral proteins, sodium chloride, phosphate, egg proteins, two antibiotics, betapropiolactone, nonylphenol ethoxylate.
MedImmune's live virus nasal spray vaccine: Approved for anyone 2 years through 49 years of age. There is no mercury.
Other ingredients include: the live viruses, egg protein, MSG, pig gelatin, arginine, sucrose, potassium phosphate, an antibiotic,
How are these vaccines manufactured?
Here is the interesting part. Everyone has been worrying and theorizing about how these BRAND NEW vaccines are going to be made and what new and dangerous ingredients they might contain. Well, what has ended up happening is that these four companies have made their "swine" flu vaccines using the exact same process and ingredients that they've used for their regular flu vaccines. All they've changed is the strain of the flu germs that go into the vaccine. Not to say that these vaccines are completely chemical free and 100% safe. But we aren't dealing with brand new flu vaccines here. We are dealing with the same thing we face with flu shots every year: same chemical ingredients, new flu vaccine strains. You can find out more details on how regular flu shots are made in the flu chapter of the vaccine book, and apply that same process to the "swine" flu vaccines.
- Sanofi Pasteur's pandemic H1N1 vaccine is analogous to their regular flu vaccine Fluzone, a brand that has been in use for several years.
- CSL's pandemic H1N1 vaccine is analogous to their regular flu vaccine Afluria, a newer player in the flu vaccine market that was first made last year for the 2008/2009 flu season.
- Novartis's pandemic H1N1 vaccine is analogous to their regular flu vaccine Fluvirin, which has been around for a few years (previously made by Chiron).
- MedImmune's live nasal spray pandemic H1N1 vaccine is analogous to their regular nasal spray Flumist.
Which one do I recommend?
At this time I have absolutely no preference whatsoever.
How many doses are needed?
All infants and children from 6 months through 9 years of age are supposed to get two doses of this vaccine, one month apart (no matter what brand you are using, and you probably shouldn't switch brands between the two doses). This is needed to generate an adequate immune response. Anyone who is 10 years and older only needs ONE dose.
Can doses be given along with other vaccines?
The product inserts make it very clear that no testing has yet been done on these versions of the flu vaccine to determine if they can be given along with other vaccines. The government is operating under the assumption that these vaccines should behave the same way as their regular seasonal flu vaccine counterparts. So, the unofficial word is that you can give them with any vaccines, or apart from any other vaccines in any time intervals you want.
Technically you can get them together (both flu shots together) or with any other vaccine. But my advice? Get them alone, as far apart as you can from another flu shot or any other shots. More on this below.
What safety and efficacy testing has been done on these vaccines?
Here is where we are flying by the seat of our pants, so to speak. The product inserts make it VERY clear that the "swine" flu versions of these vaccines have NOT undergone any testing to demonstrate whether or not they are safe and whether or not they even work. They are relying on the fact that they are so similar to the regular flu shots that they should work just as well.
Although I don't like that approach, I must admit that they may be right. I don't see any reason to doubt that our immune systems won't respond to this vaccine the same way they respond to regular flu shots. And I don't expect that the side effects would be any different either. In The Vaccine Book, I give a lot of detail about flu vaccine ingredients and side effects that you should be aware of before getting this shot.
I've heard that the last swine flu vaccine caused a really bad reaction called GBS? What about THIS swine flu vaccine?
Every product insert for this new vaccine discusses this issue from 1976 in which the old swine flu vaccine caused a higher rate of GBS (weakness and paralysis reaction) than expected, so they stopped using it. That was a completely different strain of the swine flu than what we have today. Plus, that vaccine was made much differently than how they are made today. So, I see no correlation between the risk of GBS from that old vaccine and the current one.
Having said that, everyone needs to be aware that ANY flu vaccine poses a very small risk of a GBS reaction. Although I don't think this new vaccine has an increased risk, what I DO worry about is that infants will be getting FOUR (count them, FOUR) flu vaccines this year - two doses of the regular one, and two doses of the swine flu vaccine. That's unprecedented. We've never given anyone four doses of a flu vaccine in one year. There is no way to predict what the side effects might be.
What about pregnant and/or nursing mothers?
This is a little scary. The flu shots are ALREADY recommended for pregnant and nursing moms, BUT (and this is a really huge but) the vaccine product inserts make it very clear that the regular flu vaccines have never been tested on pregnant or nursing women to determine if there is any harm to fetuses or young babies (with one exception - the Flumist nasal spray brand did have some testing in this area, BUT not enough, as is stated in the product insert).
Despite this complete lack of research, it is recommended for these moms anyway. Anyone see a problem with that?
If you do get a flu shot, at least make sure it is mercury free (or at least only TRACE mercury).
What should I get first, regular or swine flu shots, and how do I space them out?
My basic advice for anyone is to only get one flu shot at a time, spaced out one month apart. So, it would take 3 months to work in all four doses (2 regular flu and 2 swine flu). I have no preference on how you go about doing this. Do get 2 regular, THEN two swine? Or the other way around? Or do you alternate between the two? Take your pick.
The seasonal flu causes about 20 infant and 100 total pediatric deaths each year in the U.S. The swine flu has so far caused 112 pediatric deaths. So, that's about the same as the regular flu. From April through the end of July, there were about 43,000 confirmed swine flu cases, with 5000 hospitalizations and about 300 deaths in all ages according to the CDC website. More deaths have occurred since then. This is no different from the regular flu. They've stopped officially counting the number of cases because it's now too widespread to keep track of. But the bottom line is that the swine flu is about the same level of seriousness as the regular flu. So, take your pick which to do first. You may want to start with the regular flu shot since it's available right now.
What about other routine childhood vaccines that are also needed during this time?
I would advise parents to delay any vaccines for diseases that don't pose an immediate danger to a baby's or child's life and catch up on those vaccines in Feb or March, a couple months after finishing the flu vaccines. Diseases that aren't usually life-threatening (keeping in mind that ANY disease can be fatal, but the following are less likely to be) include measles, mumps, rubella, chickenpox, and Hep A. Diseases that don't exist in the U.S. or that don't occur during infancy in the U.S. (so even though they can be very severe, a child has almost no risk of catching it in the U.S.) that could be safely delayed are polio, Hep B, tetanus, and diphtheria (although to get a pertussis vaccine, tetanus and diphtheria have to come along with it).
Diseases that DO pose an immediate danger to babies and children are HIB and PC meningitis, Rotavitus, and Pertussis. So, I would rather children stay on time with those four vaccines and delay the flu shots (if you feel comfortable delaying flu shots).
If you want to make sure your child has flu coverage and stays up to date on these other shots, you can stagger them by two weeks.
For teens, I would follow the same guidelines - don't get flu shot around any of the other routine teen shots like HPV, meningococcal, or Tdap. The only disease here that would be more severe than flu would be meningococcal, so that's more of a priority.
Should people even get any flu shots?
I don't have a recommendation one way or another. There hasn't been a lot of research on safety and efficacy of flu shots (just read through the product inserts - the sizes of the research studies are very small compared to all other childhood vaccines), and the product inserts are very clear about where the research is lacking (almost seems like a disclaimer in there).
BUT, the flu can and does kill people every year. I do believe the flu shot helps protect against the flu and lowers this risk. I go over many of the pros and cons in The Vaccine Book. Everyone has to make their own choice on this. I'm not going to make a suggestion one way or the other.
You can review all the product inserts yourself from the homepage of
Labels: Vaccine News
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