H1N1 (Swine Flu): To Vaccinate or Not To Vaccinate

A week or so ago, our friends at StrollerTraffic.com came to us with their readers' most pressing questions about the new H1N1 vaccine. Seems their inbox (like ours) has been overflowing with questions, confusion, and dare we say, a little bit of panic.
Being on their panel of experts, we of course were happy to field the most frequently asked questions, break down the facts, explain some of the issues and controversies surrounding the vaccine, and hopefully talk a couple of readers down off the ledge so they could make a sound, educated decision about whether to vaccinate or not to vaccinate.
Here, the full unedited version of "Worth a Shot? H1N1 (Swine Flu) Vaccine Update", originally written for and published by StrollerTraffic.com.
(Disclaimer, it's a bit long...but we think, worth the read...So fill up your coffee cup, put up your feet, break it down into 2 parts if you have to, and enjoy!):

WHEN WILL THE VACCINE BE AVAILABLE?
The first 7 million doses of H1N1 vaccine began shipping the week of October 5. Another estimated 60-195 million doses are anticipated to ship over the next few months in weekly batches. Currently we have no information as to the where the rollout of the doses will occur. The best strategy is to watch your local news and keep abreast of notices posted or sent by your health care provider.

ARE THEY ANTICIPATING ENOUGH TO MEET DEMAND? WHO ARE THE PRIORITY RECIPIENTS?
Hopefully, yes -- especially as it pertains to high risk individuals. The first groups who will be targeted for immunization are the following:

• Household members/caregivers of babies under 6 months of age
• Children 6 months - 4 years of age
  
• Children 5 years - 18 years of age with high risk health conditions (asthma, lung disease, sickle cell anemia, heart disease, chronic kidney disease, immune compromise, chronic asprin therapy, blood diseases, neuromuscular diseases, diabetes, and HIV)
• Pregnant women
• Adults with high risk health conditions
• Health care workers
• Very obese individuals (BMI >35)
• Elderly living in nursing homes & assisted living facilities

IS THERE ANYONE WHO THE VACCINE IS NOT RECOMMENDED FOR?
For individuals with severe egg allergy, or history of anaphylaxis to egg or any components of the vaccines, immunization is not recommended. In addition, individuals with a history of Guillain-Barre Syndrome shouls not receive the influenza vaccine.

WHAT ARE THE DIFFERENCES AMONG THE 4 VERSIONS OF THE VACCINE?
Currently 4 manufacturers have been producing H1N1 vaccine. Three are producing shots, and one is producing a nasal spray.

• CSL Brand: FDA-approved for individuals 18 years of age or older
• Novartis Brand: FDA-approved for people 4 years of age or older. There are 2 forms of this shot:
  1: Multi-dose vials -- using thimerosal as a preservative
  2: Pre-filled single-dose syringes -- thimerosal used in the manufacturing process but extracted before final production
  

• Sanofi Brand: FDA-approved for children 6 months of age or older. There are 2 forms of this shot.
  1: Multi-dose vials -- thimerosal-free
  2: Pre-filled single-dose syringes -- thimerosal-free
  
  
• Medimmune: FDA-approved nasal spray for individuals 2 years of age to 49 years.

The SAME stringent manufacturing standards and processes used for the production of regular seasonal influenza vaccine apply to the H1N1 vaccine as well.

WHAT SHOULD I KNOW ABOUT THE VACCINE IN NASAL SPRAY FORM AND HOW DO I CHOOSE BETWEEN THE SHOT AND THE NASAL SPRAY FORM?
The mist form of H1N1 vaccine is very similar to Flumist - the vaccine used for seasonal flu protection. It is a live-attenuated vaccine, and is thimerosal-free. It is FDA approved for healthy people 2-49 years of age. Two doses are needed for kids under 10 (given a month apart), and one dose for kids 10 years of age or older.
If your child does not have a history of asthma, recent wheezing, or a high-risk health condition, the mist form of the H1N1 vaccine is a non-painful option for your child. The downside might be a day or two of sore throat, sniffles and/or a low-grade fever. Live virus preparations typically activate a different arm of the immune system and may result in more prolonged immunity. The H1N1 pandemic vaccine in mist form is free, however your health care provider will likely charge an administrative fee to cover the cost of staff time, disposal of syringes, and administrative time necessary to obtain the vaccine.
Certain individuals SHOULD NOT receive the mist form of H1N1 vaccine. They include:

• Individuals with severe/anaphylactic reaction to egg or components of the vaccine (gentamicin, gelatin or arginine)
• Pregnant women
• People with asthma or active wheezing; children under 5 years of age with recurrent wheezing
• People with immune deficiencies
• People with underlying medical conditions that may be aggravated by live vaccine (always check with your health care provider)
• Children under 2 years of age
• People with extremely stuffy, congested noses (as absorption of the vaccine may not occur)
• Children or adolescents on chronic aspirin therapy
  

SHOULD I WORRY IF MY CHILD CAN ONLY GET A FLU SHOT THAT USES THIMEROSAL PRESERVATIVE?
No. Priority for thimerosal-free vaccine will be given to pregnant women and children. However, if the only flu vaccine available for administration is one in which thimerosal was either used in manufacturing or a tiny amount in the final product, it is still a good idea to get the vaccine.
Thimerosal is a preservative that has been used since the 1930's to prevent contamination isn some multi-dose vials of vaccines (preservatives are not required for vaccines in single-dose vials). Thimerosal contains approximately 49% ethylmercury, not to be confused with Methlymercury (found in sushi and large pelagic fish such as halibut, swordfish and tuna). The kidneys excrete thimerosal very effectively, while methylmerciry is fat-soluble and more likely to be absorbed by its host.

There is no convincing evidence of harm caused by the low doses of thimerosal in vaccines, except for minor reactions like redness and swelling at the injection site. However, in July 1999 the Public Health Service (pHS0 agencies, the American Academy of Pediatrics (AAP) and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure.
Thimerosal-free influenza vaccines are available, but in limited quantities (availability will improve as manufacturing capabilities are expanded). Priority for thimerosal-free vaccine will be given to pregnant women and children. However, if the only flu vaccine available for administraion is one in which thimerosal was either used in manufacturing or a tiny amount in the final product, it is still a good idea to get the vaccine. To date, there is still not any substantial proof that thimerosal is harmful in any way.

ARE THERE ANY CONTROVERSIES AROUND THE VACCINE, ITS INGREDIENTS, ETC?
The H1N1 vaccine does NOT contain any aluminum or other adjuvants (products that increase a body's response to a vaccine). Other countries have used adjuvants since 1997 but the US manufacturers have never done this. As a result all H1N1 vaccine (in all forms) is adjuvant-free. This has been a source of debate because using an adjuvant makes it easier to create more vaccine to meet demand.
Many parents have come to use with concerns that the H1N1 vaccine may cause Guillain-Barre Syndrome (GBS). Certainly on the internet this concern is a hot topic. It's worth a little extra reading on the CDC website to set the record straight.

IS IT A ONE DOSE SHOT OR IS A BOOSTER REQUIRED?
H1N1 vaccine has slightly different ground rules* than regular seasonal flu vaccine. Think of the first dose as "priming" the immune system, and the second one as "activating" the child's immunity. One dose will NOT protect a child 6 months of age through 9 years.
*Normally, regular seasonal flu vaccine requires 2 doses the FIRST YEAR it is given for children under 9 years or age, and then once yearly after that.)

ARE THERE ANY POSSIBLE SIDE EFFECTS CAUSED BY THE VACCINE?
Typical reactions to the H1N1 vaccine are anticipated to be the same as those experienced with regular seasonal flu vaccine. For the shots, these include possible pain/soreness at the injection site, muscle ache, headache, low grade fever (usually for a day or two), fainting (usually in adolescents) and rarely allergy to one of the components of the vaccine. For the nasal mist preparations (since they have low levels of the live virus) nasal congestion and stuffiness are fairly common for a few days after administration, in addition to possible low grade fever, muscle aches and fatigue.

HOW HAS THE VACCINE DONE IN CLINICAL TRIALS?
Two different 2009 H1N1 influenza vaccines have been enrolled in clinical trials as of July 2009 -- one made by Sanofi Pasteur in Swiftwater, PA and the other by CSL Limited in Melbourne, Australia. Initial review of the data involving more than 500 healthy adult volunteers showed both vaccines to be safe and effective. Because of these positive results, clinical trials began on children on August 18, 2009 using the Sanofi H1N1 vaccine.
The pediatric trials have involved eleven medical centers nationwide, and more than 1200 children between the ages of 6 months to 17 years have been given the vaccine. Preliminary results published 9/21/09 showed that an effective immune response was seen in the majority of 10-17 year old eight to ten days after receiving the vaccine. Younger children generally had a weaker early response to the vaccine.
Current ongoing studies are addressing whether there is a dose:response relationship with the vaccine - i.e. is giving more of the vaccine going to yield better or longer immunity? In addition, the effectiveness of combining seasonal influenza vaccine with the 2009 H1N1 vaccine is also being examined. Data will be updated as it comes in from the National Institutes of Alelrgy and Infectious Diseases (NIAID) and from the National Institute of Health (NIH).

SHOULD MY CHILD GET BOTH THE SEASONAL FLU VACCINE AND THE H1N1 VACCINE?
Yes, it's a good idea to protect your child from all threatening strains of flu this year. Most health care providers already started administering regular seasonal flu vaccine early in September. Unfortunately, full production and shipments of vaccine to all health care entities were held in order to produce H1N1 vaccine. As a result, your health care provider may be awaiting shipment of more regular seasonal flu vaccine (especially preservative-free formulations) -- and all any of us can do is wait patiently for the remainder.
Both seasonal flu shots and H1N1 shots can be given on the same date and if a repeat dose is needed, those doses can be given together as well. The only tricky part here is that a child cannot receive protection from two MIST preparations on the same day. So a parent has the prerogative to opt for one shot/one mist. If you only want your child to receive flu protection in mist form exclusively, you must separate all those doses by 4 weeks -- thus stretching out immunization over 4 months and possibly delaying the timely administration of second doses, if required.
Also, keep in mind that if your child has had any other live virus vaccine (ie MMR, Chicken Pox or Rotavirus vaccine) within the last month, you should wait FOUR weeks after that vaccine before administering any flu vaccine.

AFTER WHAT DATE IS IT TOO LATE TO GET THE VACCINE?
Peak flu season varies across the US -- on the East Coast and Northern regions flu season peaks around the holidays, whereas on the West Coast and Southern regions, often it peaks as late as February. Unfortunately, since H1N1 novel strain seems to know no "season" (having surged in the Spring, quieted a bit in summer, now ramping up again) anytime is appropriate, but the earlier the better. What we have yet to know is whether we will need to have to repeat inoculations more than once yearly, given the propensity of H1N1 to occur year round (as typical influenza vaccines last generate only 4-6 months of immunity).

For regular updates on H1N1 and its vaccine, we suggest you visit the CDC Website regularly, and/or follow @CDCflu on twitter.

To read the edited version of this article, "Worth a Shot? H1N1 (Swine Flu) Vaccine Update" visit StrollerTraffic.com and their health and safety section.