H1N1 vaccine - info from the manufacturer

[science_spot]

The first stock of H1N1 flu vaccine has been released in the United States, manufactured by Sanofi Pasteur.  Visit there pandemic website for updates.  This company is based in France and is the largest company in the world that focuses solely on vaccine research and production.  They make the seasonal flu vaccine (and many others) for use all over the world, including the United States.  They do have FDA approval for use of their products in the USA.  Recently the product information sheets were posted on the FDA's website.  I would like to go over that document here, in order to help you understand the information from the manufacturer and how it relates to your H1N1 vaccination decision.  There are other manufacturers of this vaccine, and their production scheme may be different.  If you have any questions about this information or that from other product inserts, please let me know!

I would like to discuss the injectable vaccine information sheet, but you may also be interested in the inhaled vaccine product information sheet (this product is made by MedImmune).  You will need to open the document and actually read it.  If you read only my comments, you will not have the advantage of seeing the original wording in the document nor will you have the opportunity to learn how to read vaccine product inserts for yourself.

This is a very long document meant for the doctors and patients to have a starting basis for understanding the vaccine product.  If you have additional questions, you can call their customer or technical service and see if they can help you.  Or you may ask your doctor or ask here and I can get you the answers you need in order to make your decision on vaccination.  Knowledge is power!  The decision is yours and I am here to help you understand the science.

 

Section 1. The name and description of the vaccine tells us alot about it. The name Influenza A (H1N1) 2009 Monovalent Vaccine tells us the type of influenza it is designed to immunize against (H1N1 from 2009 - for more information on understanding the types of flu and the naming convention, see my past post on H1N1 FAQs).  The term "monovalent" means it is only designed against one type of flu virus.  This is significant because the seasonal flu vaccine is designed against 3 different viruses (none of which are the H1N1).

 

Section 2. 

Part 2.1 This explains what the nurse administering the vaccine should look for in the vial, and how to properly handle the vial so the vaccine is most likely to be effective.  For example, if they don't shake it, some particles won't be administered to the patient and would be left in the bottom of the vial - this could render the vaccine useless.

Part 2.2 The recommended dose schedule explains when to get the shots so that the likelihood of it working is highest.  They state that children 9 years of age and younger are "serilogically naive" to the H1N1 virus.  This means they tested a group of kids for antibodies and most do not have them, which means most kids do not have any immunity to this H1N1 virus (as expected).  Currently, they recommend children under 10 to get 2 doses, which was increased from the recommendation of 1 dose earlier this year. The reason for the increase is a subject we will get to later in this post.

 

Section 3.  Here is the part where you will see that multi-dose vials contain thimerosal as an antimicrobial agent.  This is necessary in order to prevent bacterial contamination in the vial as a result of using multiple syringes to draw out the vaccine at different times.  Introducing bacteria into the bloodstream can lead to very serious complications and should be avoided at all costs (which is why they still use thimerosal in vaccines despite the bad publicity and growing concerns with a possible link to neurological disorders).  If thimerosal is a concern for you, ask your doctor for the single use pre-filled syringes which do not contain thimerosal and make sure they open the package in front of you.  You do have a choice, but availability may be limited.

 

Section 4.  The contraindications tell you who should not recieve this vaccine.  You should always read the contraindications of EVERY medication you introduce into your body.  You have the control over this and the information is provided to you.  Read it!

 

Section 5.  Warnings give the company a chance at a disclaimer.  Read them and understand what they mean before making your decision.

Part 5.1 - First a little background, and then I will explain what this part is saying.  Guillain-Barre Syndrome was increased in the population during a small H1N1 vaccination campaign in the 1970s.  Research into the cause has not provided any conclusive evidence, as some data shows the increase was statistically insignificant, and others showing what they claim is a causal link.  Now, generally people believe that squalene used in those vaccines was the cause.  Either way, squalene is not an ingredient in vaccines made for use in the USA, but it is still used in vaccines made for other countries (without incident).

Aside from that history, this section indicates that those people already affected by GBS may have a problem with recurrance.  This part is not saying that it will cause new instances of GBS.  This point is one of the most popular topics exploited in fear-mongering and anti-vaccine websites.

Parts 5.2 and 5.3 mention the possibility of people with compromised immune systems and allergy issues may have complications with this vaccine.  That is no different than the implications from any other vaccine.

Part 5.4 is a disclaimer indicating the vaccine "may not" protect all recipients.  It would be more correct to say "will not" because they know, and actually show the data later on, that the success rate is approximately 70% (at best) for any flu vaccine.  This is not the same for ALL vaccines, so do not believe anyone that uses this data to tell you all vaccines are worthless and do not work.  Vaccines against other diseases need to be evaluated separately.

 

Section 6 indicates the recorded adverse reactions (both in clinical trials and post-market use).  In this section, they state the same process is used to manufacture the H1N1 vaccine as is for the seasonal flu vaccine, so their data actually comes from the seasonal trivalent flu vaccines.  In my opinion, there isn't any reason to think the reactions would be any different because it works against a different virus.  The CDC and FDA agree, as they allow this data from past flu vaccines to support the safety of this product (as they do with every flu vaccine every year, as long as the manufacturer does not change the manufacturing process).  Read through this section if possible reactions is a concern of yours.

 

Section 7.  Drug interactions can be very serious and if you are taking any medication I strongly encourage you to read through this section and talk to your doctor before the vaccine is administered.

 

Section 8.  Use of this vaccine is specific populations, such as pregnancy, nursing, etc. This information is again pulled from the data available for seasonal flu vaccines using the same manufacturing process.  I think part 8.3 (notice the mis-numbering as part 8.2 is skipped) deserves a clarification.  If you are nursing a baby below 6 months of age, this warning is more important since a child that age is not able to get the flu vaccine directly.  Any child over that age could get the vaccine at the same time as the nursing mother and there should be less of a concern with human milk virus and antibody transmission to the child.  Definately talk to your doctor if you fall into any of these special populations. 

Note - I found the vaccine product insert on Sanofi's website as well and the misnumbering is there, too. I believe it is a typo.

 

Section 11.  I am not sure why the insert skips to section 11 either!!  This section describes, in detail, the characteristics of the vaccine. Here they tell you the products they use in order to grow and process the vaccine.  I will note a few things here, but if you have more questions, please let me know.  I understand much of this process in great detail (and they havedetailed, excellent information on Sanofi's website), but I don't want to make this post overly complex.  One of the first steps in producing the vaccine is to grow large quantities of the virus, which they do in chicken eggs (this is why those allergic to eggs should not get this vaccine). Once the virus is made in large quantities, they use a series of processes (and chemicals) to purify the virus from the egg components.  Next, they break the virus up into parts (which is why it is called a "split virus"), which renders it "dead" and not able to cause infection or reproduce in your body.

 

Section 12.  This section explains in general how a vaccine works.  It is noteworthy that the way they determine if a vaccine is successful in providing an immuno-response is by testing the antibody titer.  The purpose of vaccination is to make your body produce antibodies (which fight pathogens in the body and kill them).  The measurement of antibody production is by measurement of antibody titer (a fancy word for antibody level in your body).  Their data indicates an antibody titer of > 1:40 is associated with immunity against the virus.  This is important when we get to the data in a later section. 

For the H1N1 vaccine, they did do some additional testing of antibody titers.  The results indicate that after the first injection, the antibody titer of most participants is well below the target of > 1:40.  For this reason, they recommend the patient recieve a second injection.  they did this same thing withthe recommendation for the varicella vaccine (chicken pox). In my opinion, I would rather they take the time to develop the antigen used (split virus particles) rather than rushing through it.  However, the USA government (through the CDC) was in too much of a hurry and wanted production to continue despite the fact it was known that the vaccine would have a low level of effectiveness.

 

Section 13 is another quick warning.

 

Section 14.  Clinical Studies is how they gather the data to understand the safety and efficacy of the vaccine.  Again, this information comes from their seasonal flu vaccines.  The important part of this chart is given in each line for young (average age) humans and their titer (given in the last column).  Notice how the vaccine is effective in usually about half of the recipients (assuming the > 1:40 antibody titer is the level that indicates immunity has been achieved).  In my opinion, this is pretty low.  Compound that (in seasonal vaccines), with the fact that if the circulating virus is not the same as the one used to make the vaccine, the effectivity drops to nearly zero.

 

Sections 15-17 provide some additional information about handling the vaccine and references, etc.

 

Was this post helpful?  Please let me know what questions youhave.  I have here to help you understand and make your own decision, not push a vaccination agenda on you.  I welcome your constructive criticism on my writing and explanationsin this post!

 

Tonya

AKA sunmoonstars

The Science Spot

 

 

[aenima49]

Oct. 7, 2009 at 10:54 AM

Very good info.  8.1 and 8.3 (wow typos much, huh?) I think are just to CYA.  According to my doc I should definitely good the vaccime since my son is too young to get it himself, and my nursing  him will not hurt him in any way.

[aenima49]

Oct. 7, 2009 at 10:55 AM

Ack vaccine not vaccime.

[Momforhealth]

Oct. 7, 2009 at 11:45 AM

Information just flows out of you like water flows down a river.  What a gift you have. Thank you..I could not understand it without you.  Dr.s here are terrible and want to rush you in and out.  I will be printing this..

[science_spot]

Oct. 7, 2009 at 12:46 PM

MomforHealth - you are so kind, thank you!

YES they do rush you too much and they don'tnecessarily know it all either. 

 

Aenima - yes always talk to your doc :)

 

(Original Poster)

[arthistmom]

Oct. 7, 2009 at 1:51 PM

We'll be reviewing this info. We still haven't decided--still in research mode. Thanks for sharing this!

[sandra1023]

Oct. 7, 2009 at 10:44 PM

Will you be getting the vaccine (or allow your kids to get it, if you have kids under 18)?  You can certainly say that this is none of my business.  I'm just curious, being that you probably understand more about this than the average person.

[science_spot]

Oct. 8, 2009 at 10:25 AM

sandra - My personal thoughts on this appear in today's Daily Buzz - http://www.cafemom.com/dailybuzz/healthy_living/7693/Swine_Flu_Vaccine_Another_Moms_Take

We won't be getting this vaccine because I am not convinced it works!

 

(Original Poster)

[mommytoadam]

Oct. 8, 2009 at 10:36 AM

Very thorough information!  I always learn a lot from you.  Thanks for the time you put towards this.  I do have a question though - is there anywhere that you've come across that lists the ingredients in the vaccine?  I have heard conflicting information and wanted to do more research.  I am very much a vaccinating parent, but am leaning more towards not getting this one.  I just have this gut feeling telling me to wait, but I still would like more information on it.

[roseisrose]

Oct. 8, 2009 at 10:37 AM

thank you so much for the info!

[science_spot]

Oct. 8, 2009 at 10:59 AM

mommytoadam - the package insert gives the ingredient (in paragraph form) in section 11 as they describe the manufacturing process.  There are some additional chemicals in there, but those are not considered components added as ingredients - they are leftover in minute trace amounts as carryover from specific steps in the manufacturing process (such as albumin from the egg cultures).

Most comprehensive lists of ingredients I have seen list dozens of compounds - these are the contaminants being listed as well, even though there may be < 1 molecule of the stuff in the vial of vaccine meant for one patient.  These are often components in the culutre medium (used to grow the virus), many of which are naturally occurring elements.

(Original Poster)