General H1N1 FAQs
Below are some general questions being asked about pandemic H1N1 influenza and about the vaccine being used to immunize against the virus. For a more complete list of questions and answers, see the
Saskatoon Health Region FAQs (PDF).
Select a question to view the answer or scroll down to read them all:
- What is pandemic H1N1 (pH1N1)?
- What is the difference between pH1N1 and the seasonal flu?
- What are the symptoms for pH1N1?
- How is pH1N1 spread?
- What is the situation for pH1N1 in Saskatchewan?
- What about First Nations and Metis communities?
- Is pH1N1 more serious (severe) than seasonal flu?
- Who is most at risk (vulnerable) for pH1N1?
- Can I get pH1N1 from pigs or from eating pork products?
- How long can the virus survive on surfaces?
Questions about pH1N1 Vaccine
- When will the vaccine be here?
- Why did you pick children instead of people with chronic health problems?
- Why do you need consent forms for this flu vaccine?
- How many doses are you getting? Will there be enough vaccine?
- Who made the pH1N1 vaccine?
- What is an adjuvant?
- Why is Canada using an adjuvanted pandemic vaccine?
- What is the adjuvant being used in Canada's pandemic vaccine?
- What is in the pH1N1 vaccine?
- Why are there two types of pandemic pH1N1 vaccine in Canada?
- Is the pH1N1 vaccine safe?
- Is the adjuvant used in the vaccine safe?
- Are 2 vaccinations required?
- What is the risk of Guillain Barre Syndrome (GBS) for people who receive pH1N1 vaccine?
- Can people with fish allergies get the adjuvanted pH1N1 vaccine?
- Do I need to pay for the pH1N1 vaccine?
- Will the H1N1 vaccine be passed on to infants whose mother's breastfeed them?
- Are there side effects from the vaccine? What are the side effects?
1. What is pandemic H1N1 (pH1N1)?
The current pandemic H1N1 virus is a strain of influenza, also known as swine flu. It was first identified in April 2009 following an outbreak in Mexico. It is not very closely related to other recent human influenza strains. It is sometimes referred to as swine flu because it is close antigenically to strains which infect pigs.
It has been labelled as a “pandemic” strain because its structure is quite different from seasonal influenza strains circulating in recent years. Because of this it can potentially spread more rapidly and infect more people than seasonal influenza usually does.
2. What is the difference between pH1N1 and the seasonal flu?
Seasonal influenza viruses change slowly as they circulate around the world. pH1N1 influenza has appeared and spread more quickly than seasonal influenza viruses typically do.
Because this is a new strain, most people will likely have little natural immunity to protect against the virus.
3. What are the symptoms for pH1N1?
- Sudden onset of fever and cough.
- There may also be sore throat, muscle aches, joint pain, chills, fatigue or weakness, lack of appetite, and headache.
- Vomiting and/or diarrhea may be present in children and fever may not be prominent, especially in the elderly.
4. How is pH1N1 spread?
pH1N1 influenza is spread the same way as regular seasonal influenza.
It can be spread directly from person to person through coughing or sneezing.
Germs can also rest on hard surfaces like counters and doorknobs, where they can be picked up on the hands and transmitted to the respiratory system when someone touches their mouth and/or nose. It can be spread indirectly by touching contaminated items then touching the eyes, nose or mouth.
Transmission is most likely to occur during the first few days of obvious illness. It is recommended that persons who are ill with influenza symptoms should stay home from work or school and limit contact with others and not return to routine activities outside the home until they are symptom free or for 7 days, whichever is shorter.
Influenza is a respiratory illness and cannot be spread through food.
5. What is the situation for pH1N1 in Saskatchewan?
There is currently still a significant amount of influenza transmission in the Saskatoon Health Region, although less than at the peak 1 - 2 weeks ago. There will continue to be a risk of infection over the next 1 - 2 months, if pH1N1 follows the pattern of seasonal influenza.
6. What about First Nations and Metis communities?
Saskatchewan established enhanced surveillance for disease activity in northern and remote communities.
Enhanced surveillance will continue throughout the fall and winter flu season.
The Ministry of Health, working closely with the health regions, has ensured quick access to antiviral medication, which has helped to contain the spread of the disease in some isolated areas.
The Ministry of Health is working with health regions, provincial and federal partners to ensure our most vulnerable populations receive timely and appropriate care.
7. Is pH1N1 more serious (severe) than seasonal flu?
The pandemic pH1N1 seems close to seasonal influenza in severity overall, although more of the serious cases and deaths are occurring in young and middle aged adults than is the usual case with seasonal influenza.
8. Who is most at risk (vulnerable) for pH1N1?
Although there is a shift of the more serious cases and greater percentage of deaths to young and middle aged adults, most of those with serious disease also have medical risk factors or conditions similar to those which put people at risk for serious disease with seasonal influenza. Pregnancy in particular is a risk factor for serious disease. Severe obesity has been identified as a new risk factor for pH1N1.
9. Can I get pH1N1 from pigs or from eating pork products?
Humans and animals can pass strains of flu back and forth to one another through direct close contact – such as in pig production barns. For people in close contact with pigs, the recommendations to avoid infection are the same as for regular seasonal influenza- frequent handwashing, getting an annual flu shot, covering coughs and sneezes, and staying home when ill.
Because humans can also spread the disease to pigs, individuals with influenza symptoms should avoid close contact with pigs, to reduce the risk of introducing a new influenza virus into domestic swine populations.
Eating pork products: No, pH1N1 is not transmitted through pork meat. Continue to follow proper handling and cooking procedures to reduce the risk of food borne illnesses.
10. How long can the virus survive on surfaces?
pH1N1 can live outside the body on hard surfaces, such as stainless steel and plastic, for 24-48 hours and on soft surfaces, such as cloth, paper and tissues for less than 8-12 hours; however, it can only infect a person for up to 2-8 hours after being deposited on hard surfaces, and for up to a few minutes after being deposited on soft surfaces.
Questions about pH1N1 Vaccine
1. When will the vaccine be here?
The pandemic pH1N1 vaccine has been authorised for release by the federal Minister of Health. The vaccine supply was limited initially. The week of October 26th immunization of health care workers began. Immunization of identified high risk groups began the week of November 2nd, with pregnant women and children under the age of 5 being offered immunization. The vaccine made specifically for pregnant women (unadjuvanted) became available November 6. As more vaccine became available, other at risk groups were offered immunization. Vaccine became available to the general public November 25th.
2. Why did you pick children instead of people with chronic health problems?
Science is showing us since H1N1 appeared in the spring that this age group is the most vulnerable to the virus next to pregnant women. We have continued to move forward with vaccination to targeted high-risk groups determined by science, as per the sequence outlined by the Ministry of Health.
3. Why do you need consent forms for the flu vaccine? You didn't need them for the regular flu?
Although consent for regular seasonal influenza immunization is done by the immunizing nurse asking routine screening questions, most provinces will be using a written consent for Pandemic H1N1 vaccine. This includes Saskatchewan and will ensure clients receive information on risk, benefits and side effects of the new vaccine, in order to make an informed decision on whether to accept the vaccination.
4. How many doses are you getting this week? Will there be enough vaccine?
Last week we only received 13,000 doses. We are expecting to receive 41,000 doses of adjuvanted vaccine this week. It is not known how many will come next week but we expect to be receiving regular amounts of doses by then. The company, Glaxo Smith Klein, has contracted to produce more than enough vaccine to meet our needs. Everyone who wishes to be immunized, will be.
5. Who made the pH1N1 vaccine?
GlaxoSmithKline (GSK) is making the PH1N1 vaccine products for Canadians.
6. What is an adjuvant?
An adjuvant is a substance which enhances the immune system reaction to the antigen in a vaccine. Adjuvants are common in vaccines in use already in North America, although they have not been used in influenza vaccines here in Canada previously.
7. Why is Canada using an adjuvanted pandemic vaccine?
There is a very limited global ability to produce influenza vaccine quickly. Only a small number of developed countries had pre-existing contracts to guarantee rapid development and supply of vaccine for an influenza pandemic.
The World Health Organization has asked countries to use antigen sparing techniques. Using an adjuvanted vaccine allows the same level of protection for Canadians while using a much smaller amount of the total world supply antigen. The “extra” antigen freed up can then be used in other countries.
Theoretically an adjuvanted vaccine may also provide better protection in older people who do not respond as well to the standard (unadjuvanted) vaccine. It may also protect against a wider range of the later strains that evolve over time from the strain in the vaccine.
8. What is the adjuvant being used in Canada's pandemic vaccine?
GSK is using an adjuvant called ASO3. It is an oil-in-water based emulsion containing DL-α-tocopherol (vitamin E oil, 11.86 mg), squalene (a natural biodegradable oil, 10.69 mg), and polysorbate 80 (an emulsifier, 4.86 mg).
9. What is in the pH1N1 vaccine?
There are two types of vaccine being made for use in Canada by GSK: an adjuvanted vaccine and an unadjuvanted vaccine. Both contain antigen from only a single strain of influenza A (the pandemic pH1N1 strain). As is the usual process in Canada, the vaccine contains an inactivated split virus product – it is not a live vaccine and contains only part of the virus.
The unadjuvanted vaccine is made the same way seasonal influenza vaccine is.
The adjuvanted vaccine contains an ingredient (ASO3) which enhances the antibody response to the antigen (germ). The adjuvant is used to get the same amount of protection while using less antigen. In this way the global vaccine manufacturing capacity can be used to benefit the maximum number of people. Both types of pH1N1 vaccine contain thimerosal as a preservative.
Both adjuvanted and unadjuvanted vaccines also contain trace residual amounts of egg proteins, formaldehyde, sodium deoxycholate and sucrose.
10. Why are there two types of pandemic pH1N1 vaccine in Canada?
A small amount of unadjuvanted vaccine is being made available for use in pregnant women. There are no known problems with using the adjuvanted vaccine in pregnant women, but there is a need to accumulate more evidence of safety. If there is a high level of pH1N1 influenza in a particular region it may be appropriate to recommend that pregnant women in that region who are in the last half of pregnancy (past 20 weeks) receive the adjuvanted vaccine.
11. Is the pH1N1 vaccine safe?
The unadjuvanted vaccine is made with the same technology and ingredients used every year in Canada, which have a long track record of safety. The most common side effect is a sore arm at the site of injection. No notable side effects have been reported so far in countries which have already been immunizing with pH1N1 vaccine.
The adjuvanted vaccine contains an ingredient (ASO3) which enhances the antibody response to the antigen (germ). Arm pain will be more frequent for recipients of adjuvanted vaccine than the unadjuvanted product we normally use for seasonal influenza campaigns. The range of minor side effects reported so far are similar to those of seasonal influenza vaccine.
Health Canada (Biologics and Genetic Therapies Directorate) will be assessing further safety data from ongoing clinical trials as it is available.
The antigen (killed virus) in the adjuvanted vaccine is made the same way it is made for seasonal influenza vaccine every year, with the long history of safety associated with that process.
There will also be enhanced post marketing surveillance in place to detect adverse events associated with the vaccine.
12. Is the adjuvant used in the vaccine safe?
The adjuvant involved, ASO3, was first developed for use in a prepandemic H5N1 vaccine. No notable safety issues have been identified so far in its use in over 45,000 individuals apart from increased frequency of pain at the injection site.
A closely related adjuvant, MF59, has been used in a European influenza vaccine by Novartis since 1997. A safety profile has been published after its use in 27 million people which does not demonstrate any worrying issues.
Experience with the adjuvanted GSK pH1N1 vaccine now includes several million doses administered in Canada.
Side effects such as having a sore arm at the injection site, headache, fatigue, muscle pain and fever appear to be more common than with regular seassonal influenza vaccine (unadjuvanted).
Analysis of adverse events is now underway across Canada. Most reports are of transient side effects expected with influenza vaccines every year. More analysis needs to be done on the frequency of allergic reactions associated with the vaccine.
GBS (Guillain Barre Syndrome) has not been identified so far as a problem either with our vaccine from GSK, or with other pH1N1 vaccines (more than 80 million doses worldwide), according to the World Health Organization.
13. Are 2 vaccinations required?
The Public Health Agency of Canada has recommended 2 doses for all children who are at least 6 months and less than 3 years of age. Also for children at least 3 years and less than 10 years of age who have high risk medical conditions.
Healthy children at least 3 and less than 10 years only need one dose.
The doses must be separated by a minimum of 21 days. Second dose immunization will begin Monday, December 7.
14. What is the risk of Guillain Barre Syndrome (GBS) for people who receive pH1N1 vaccine?
The only influenza vaccine definitely associated with Guillain Barre Syndrome was the 1976 swine influenza vaccine. It had an excess risk of about 1 case per 100,000 people vaccinated. There have been repeated investigations looking for a relationship between GBS and seasonal influenza vaccine with the general conclusion that if there is a risk it is so small that we are not able to measure it.
GBS is most commonly caused by infections including influenza infections, and only rarely by vaccines.
It has not been reported yet in association with the pandemic vaccines already in use although the number of people immunized is still low.
There will be postmarketing surveillance related to the pH1N1 vaccine to detect adverse events. Further safety information on the pH1N1 vaccine will be released when the vaccine is approved for use in Canada.
15. Can people with fish allergies get the adjuvanted pH1N1 vaccine?
Yes. The squalene component in the adjuvant is extracted from shark liver oil. It is highly purified and part of the purification process involves a distillation step which destroys potentially allergenic proteins according to information provided by the company.
There is no warning about fish allergies on the labelling for either of the two pandemic H1N1 vaccines approved by the EMEA (European Medicines Agency) which contain squalene based adjuvants (GSK Pandemrix and Novartis Focetria).
The squalene based adjuvant (MF59) which is used by Novartis in their pandemic vaccine is also used in their seasonal flu vaccine Fluad. Fluad has been licensed and used in Europe since 1997 with over 40 million doses distributed. It does not have a warning about fish allergy on its’ package insert.
16. Do I need to pay for the pH1N1 vaccine?
This vaccine is available to all Canadians at no cost. This vaccine is free to all in order to decrease the impact of the pandemic strain. It is assumed that there will be higher attack rates than with seasonal influenza because most of the population has not had previous exposure to this type of strain.
17. Will the H1N1 vaccine be passed on to infants whose mothers breastfeed them?
No, the vaccine will not be transferred to breastfed infants. There is little data available at this time to show that immunization has any effect on antibodies.
0 - 6 month old babies will rely on the people around them to be immunized. Immunization in pregnancy does not provide a significant amount of protection in the first six month's of a baby's life.
18. Are there side effects from the vaccine? What are the side effects?
Adjuvanted vaccine:
Although trials are still ongoing, it is likely that the side effects are similar to those of seasonal influenza vaccine, with a sore arm being the most common. Arm pain at the injection site is more common with adjuvanted vaccines than with the usual seasonal vaccine.
The range of other minor side effects (fatigue, headache, muscle ache, joint pain) is similar to that of the usual seasonal unadjuvanted vaccine, although more data from ongoing clinical trials will be needed to judge whether they are more common.
