H1N1 Vaccine Facts and Myths

From Janet Smylie:

I have been hearing some "urban" and "rural" myths about serious side effects of the H1N1 vaccine - ie. that people have died from it, become paralyzed, or can only walk backwards. I wanted to let you know that so far there have been no reported deaths or paralysis from this vaccine. There has been some problems from previous flu vaccines (not H1N1) with Guillane Barre Syndrome which can cause paralysis - and it is estimated that one in a million people might get Guillane Barre Syndrome from the H1N1 vaccine. Otherwise common side effects can be a nuisance but are not life threatening - mostly a sore arm at the vaccine site.
Here is a list of what to expect from the vaccine:
Very common:
(10%) Headache; tiredness; pain, a hard lump at the injection site; joint pain. Very common:
(1% - 10%) Warmth, itching or bruising at the injection site; increased sweating/shivering, flu-like symptoms; swollen glands in the neck, armpit or groin. Uncommon:
(0.1% - 1%) Tingling or numbness of the hands or feet; sleepiness; sleeplessness; dizziness; diarrhea, vomiting, stomach pain, feeling sick; itching or rash. All of these side effects usually disappear within 1-2 days without treatment.
There is a little bit of a mercury based preservative in the vaccine - called thimerosol- it is less than the amount of mercury in your average can of tuna fish here is what health canada says:
The amount of thimerosal used in the influenza vaccine is very small and has not been shown to cause any harm. Canada's National Advisory Committee on Immunization (which includes recognized experts in the fields of paediatrics, infectious diseases, immunology, medical microbiology, internal medicine and public health) has reviewed the latest science and concluded, "there is no legitimate safety reason to avoid the use of thimerosal-containing products for children or older individuals." The vaccines that Canadian children and adults receive are safe.
I am concerned because we do know that Aboriginal people are dying and having serious illnesses from H1N1 which can be prevented by the vaccine.
Here is a news article that talks in a little more about the monitoring of serious H1N1 side effects in the US -

By LAURAN NEERGAARD (AP) - Nov 1, 2009
WASHINGTON - Independent health advisers begin monitoring safety of the swine flu vaccine on Monday, an extra step the government promised in this year's unprecedented program to watch for possible side effects.
Decades of safe influenza inoculations mean specialists aren't expecting problems with the swine flu vaccine, because it's made the same way as the regular winter flu vaccine. But systems to track the health of millions of Americans are being tapped to make sure - to spot any rare but real problems quickly, and to explain the inevitable false alarms when common disorders coincide with inoculation.
U.S. health officials have spotted no concerns to date, Dr. Bruce Gellin, head of the National Vaccine Program Office, told The Associated Press.
A specially appointed working group of independent experts will track the vaccine's safety, too. Although the group will deliberate in private meetings, starting Monday, its charge is to raise a red flag if members feel the feds miss anything.
"Given the rapidity with which this particular vaccine was rolled out, there seems to be an extra-special obligation to make sure things remain as uncomplicated as they have in the past," Dr. Marie McCormick of the Harvard School of Public Health, who chairs the working group, told the AP.
Vaccinations against the new flu, which scientists call the 2009 H1N1 strain, have begun more slowly than the Obama administration had hoped, with long lines for the nearly 27 million doses divided around the country so far. More is on the way, even as swine flu cases and hospitalizations continue to rise.
How many ultimately line up depends in part on public confidence in the vaccine's safety. While vaccine side effects always are monitored, the H1N1 inoculations are getting extra scrutiny in part because the last mass vaccinations against a very different swine flu, in 1976, were marred by reports of a rare paralyzing condition, Guillain-Barre syndrome.
A report in The Lancet British medical journal on Friday said the intense monitoring will be crucial for an additional reason: separating normal disease rates from real vaccine risks. For example, 2,500 miscarriages occur every day in the U.S., and about 3,000 heart attacks - and some are sure to coincide with vaccination yet not be caused by it.
Monday, McCormick's group will hear safety data from studies of the swine flu vaccine in more than 10,000 people, some conducted by the government and others by manufacturers.
"To date, no serious adverse events have suggested any safety signals with H1N1 vaccines," says a summary of the data - although it cautions that the studies aren't large enough to rule out any very rare risk.
That's where the additional monitoring comes in.
Initial reports to a beefed-up government database - where anyone can report any symptom, and serious ones get intense investigation - showed nothing unusual after the first 10 million vaccinations, Gellin said. Most reports were of sore arms and fever, plus some flu symptoms that suggested people already were infected when they got the shot, too late for it to help.
Gellin said one report of a death turned out to be caused by swine flu itself, not vaccine.
Other monitoring includes linking large insurance databases to state vaccine registries to track who visits a doctor and why after the shot, a program covering about 20 million people. Plus, there's specially targeted tracking of pregnant women, and work to tell if the risk of Guillain-Barre - which regularly strikes about 1 in every 100,000 people - really is increased slightly by flu vaccine or not.
If serious problems were to crop up, federal law makes vaccine manufacturers and health officials immune from lawsuits. But it allows for a compensation fund for proven serious side effects, just as happens today with routine child vaccinations. Health and Human Services officials are developing such a program for swine flu vaccine, just in case it's needed, spokesman Bill Hall said.
Copyright (c) 2009 The Associated Press. All rights reserved.

Dr Janet Smylie MD MPH CCFP
Research Scientist, Centre for Research on Inner City Health
Associate Professor, Dalla Lana School of Public Health
CIHR New Investigator in Knowledge Translation

More on H1N1 vaccine

Here are some more questions that came up on our last call.....see also this website:

http://www.phac-aspc.gc.ca/alert-alerte/h1n1/faq_rg_h1n1-eng.php

1. Is it safe for pregnant women 12 weeks and over to get the vaccine?

There was no time to test this vaccine in pregnant women, but previous flu vaccine's have been used in pregnant women with no ill effects. Pregnant women are especially at risk from H1N1 with serious illness among Aboriginal pregnant women. So the current recommendation is all pregnant women over 20 weeks into their pregnany get vaccinated and some obstetricians are recommending all pregnant women over the age of 12 weeks. Check with your maternity care provider.

2. Should children under 3 be vaccinated?

Yes. Again there was limited ability to text the H1N1 vaccine in children. Previous similar flu vaccines have been tested in children over the age of three. Children under the age of three are at high risk of serious illness from H1N1and considered a high risk group and children between the ages of 6 months and 10 years should be vaccinated.

3. Do children under 3 have to get 2 shots? What is the waiting period between the two shots? Will there be enough vaccines for my child to get the second shot?

The recommendation is that children between 6 months and 10 years old should get two half-doses of the adjuvanted vaccine.

Why can’t they get one full dose?

The recommendation for two half-doses of vaccine in children under 10 is aligned with the seasonal flu recommendation. The seasonal flu recommendation is that children six months to 23 months receive two half doses of the vaccine, and children over the age of 23 months to 10 years who are receiving the vaccine for the first time should also receive two half doses of vaccine. This has been shown to give children the best immune response. Since the H1N1 flu vaccine is an influenza vaccine, the recommendation stands. Additionally, reactions to the vaccine were higher in clinical trials for children who received a full dose as compared to those who received two half-doses.

4. Should children over 3 be vaccinated? How many shots will they get? See above.

5. What does adjuvant mean?

An adjuvanted vaccine is a vaccine that includes a substance that boosts an individual's immune system and increases their response to a vaccine. An unadjuvanted vaccine has no “booster” element.
Adjuvanted vaccines are included in common vaccines such as tetanus and hepatitis B. The adjuvant in Canada’s H1N1 flu vaccine is made up of natural ingredients such as water, squalene oil and vitamin E.

6. What does the adjuvant consist of? does it contain mercury?

Both the adjuvanted and non-adjuvanted vaccine contain thimerosol a mercury derived preservative. It is a very small amount and hasn't been shown to be harmful. See above also for what is in the adjuvant.

7. What are the high risk populations that should get the vaccine?

I think all Aboriginal people, especially those struggling with poverty, inadequate housing and inadequate nutrition are a high risk population based on the statistics I have seen. Other high risk populations include:
People under 65 with chronic health conditions
Pregnant women
Children 6 months to less than 5 years of age
People living in remote and isolated settings or communities
Health care workers involved in pandemic response or the delivery of essential health care services
Household contacts and care providers of persons at high risk who cannot be immunized or may not respond to vaccines
Populations otherwise identified as high risk

11. Is it safe to have both the seasonal flu shot and the H1N1 vaccine? which one is more important?

Yes it is safe to have both. H1N1 is the priority

12. What is tamiflu? will it protect me from H1N1?

Tamiflu is a medicine that can help persons at risk to serious illness who have H1N1 - is helps the body fight the virus.

13. What are the flu symptoms I should look out for? When should I go to the hospital for treatment?

Watch out for a flu that gets better and then comes back worse. Watch for any difficulty breathing - ie. breathing more quickly than usual, working harder than usual at breathing. If you have a chronic illness or are pregnant and get the flu you should contact your health care provider.

14. What strategies can I use to keep my children safe?

Handwashing, vaccination, washing shared surfaces frequently, avoiding other sick people