Questions About the H1N1 Vaccine Is the H1N1 vaccine for me? Is the H1N1 vaccine for me?H1N1 flu vaccine dosing recommendations H1N1 flu vaccine dosing recommendations
* An adjuvant is a substance that is added to a vaccine to boost the individual’s immune response. It includes a naturally occurring oil (called squalene), water and vitamin E. Co-administration recommendations
What types of health care workers can get the vaccine?
[ Back to Is the H1N1 vaccine for me? ] Does my child need a second dose?Children over six months and less than three years and children aged 3 to 9 with chronic medical conditions require their second dose of the H1N1 vaccine after 21 days. The timeframe of 21 days is flexible and can be extended. (Please see dosing recommendations) Will vaccination against the H1N1 virus be mandatory?No, vaccination against the H1N1 virus is not mandatory. It is voluntary just like the seasonal influenza vaccination program. Who should not get the H1N1 vaccine?The following persons should not get the H1N1 vaccine:
[ Back to Is the H1N1 vaccine for me? ] Will people be able to choose to get the non-adjuvanted vaccine if they are not pregnant?Yes, please see dosing recommendations Is there any concern for people who have fish allergies receiving the H1N1 adjuvanted vaccine?This matter was extensively reviewed with the vaccine regulating body and the vaccine manufacturer and there are no concerns. Persons with fish allergies can receive the adjuvanted vaccine. Squalene is naturally present in the human body. The Shark-derived squalene that is used in the production of the adjuvant is highly purified. The purification process involves three successive distillation steps at more than 120 C°. This means that any protein present that would cause an allergic response is eliminated by the purification process. For personal reasons I cannot consume any products containing pork. Does the H1N1 vaccine contain pork by-products?No. There are no traces of pork in the H1N1 vaccine. If I have received the H1N1 vaccine, can I donate blood?Yes. It is recommended that after influenza immunization with the H1N1 vaccine, wait at least 2 days before giving blood. Each vaccine has a recommended time interval between vaccination and donation of blood. Please consult your local blood services for specifics. If I have recently donated blood, can I receive the H1N1 vaccine?Yes. Please consult your local blood services for specifics regarding time between donation of blood, and receiving the H1N1 vaccine. If I have been diagnosed with the H1N1-2009 virus do I have immunity and will I still need a vaccine?When a person is infected with the H1N1 virus, they develop antibodies that provide them with immunity to that particular virus. In the case of H1N1 infection, only persons with laboratory confirmed H1N1 infection should not receive the vaccine. People who may have been informed they likely have infection with H1N1 virus which was not laboratory confirmation should receive the vaccine. Should I get vaccinated against H1N1-2009 if I have had flu-like illness since the spring of 2009?The symptoms of influenza (flu-like illnesses) are similar to those caused by many other respiratory viruses. Even when influenza viruses are causing large numbers of people to get sick, other viruses are also causing illnesses. Specific lab testing is needed in order to tell if an illness is caused by a specific influenza strain or by some other virus. Since most people with flu-like illnesses will not be tested this season, the majority will not know whether they have been infected with H1N1-2009 flu or a different respiratory virus. Therefore, if you were ill in 2009 you should get vaccinated, if your doctor recommends it. So, most people should be vaccinated with the H1N1-2009 vaccine regardless of whether they had a flu-like illness earlier in the year. Any immunity from H1N1-2009 influenza infection or vaccination will not provide protection against seasonal influenza. All people who want protection from seasonal flu should still get the seasonal influenza vaccine. Do those that have been previously vaccinated against the 1976 swine influenza need to get vaccinated against the H1N1 vaccine?The 1976 swine flu virus and the H1N1 virus are different enough that it’s unlikely a person vaccinated in 1976 will have full protection from. People vaccinated in 1976 should still be given the H1N1 vaccine. Where can I get the H1N1 vaccine?Where are the H1N1 Flu Clinics in Ottawa? Where are the H1N1 flu vaccination clinics in Ottawa?You can get your H1N1 vaccine at Ottawa Public Health Clinics. Are the H1N1 vaccine clinics for Ottawa residents only?Yes – We encourage all persons to get vaccinated where they live. Information on H1N1 clinics in the Province of Quebec. I’m a health care worker, where can I get vaccinated?Some health care facilities will be receiving first vaccine shipments soon. Please contact your supervisor/manager, occupational health or infection control in your facility depending on the process normally in place for other vaccines. Alternatively, you can come to an Ottawa Public Health H1N1 Flu Clinic. Do I have to pay for the H1N1 vaccine?No. The pandemic influenza A H1N1 vaccine is available free of charge to individuals who live, work and attend school in Ontario and Canada. Do I have to go back to the same place to get my 2nd dose of H1N1 vaccine?No, you do not need to return to the same delivery location where you received your first dose of vaccine. You may go to any Ottawa Public Health Clinic or you can ask your health care provider about where you could receive the second dose of H1N1 vaccine. Make sure that you bring your/your child’s influenza immunization card with you for each visit as wells a valid Ontario Driver’s Licence. H1N1 vaccine safety, adjuvants and thimerosalWhat are the risks from Arepanrix TM H1N1 vaccine? What are the risks from Arepanrix TM H1N1 vaccine?Serious effects from the vaccine are very rare. Most people have no problems after receiving an influenza vaccine. Possible side effects are as follows:
If you experience any of the above effects please contact your local physician or visit your local urgent care clinic or emergency department. Be sure to keep your personal immunization record up-to-date when you receive the vaccine. Carry this record (influenza immunization card) with you should you become ill and see a doctor or attend a clinic or hospital so they will know that you have had the seasonal influenza vaccine, and one or two doses of the H1N1 vaccine and the date the vaccine(s) was given. Will the new H1N1 vaccines be safe?Licensed vaccines, including influenza vaccines, are held to a very high standard of safety. All precautions will be taken to ensure safety of new pandemic vaccines and results from clinical trials, both completed and currently ongoing or soon to be initiated, will be taken into consideration by the regulatory authorities in their decision to license pandemic vaccines. How well does the H1N1 vaccine protect against pandemic influenza?Based on early studies, ArepanrixTM is expected to be a very effective vaccine to prevent H1N1 infection. Why has Canada ordered a vaccine with an adjuvant for the general population, rather than one that does not have an adjuvant?The World Health Organization has recommended that countries use dose-sparing vaccines whenever possible. By developing an adjuvanted vaccine, we use less of the virus material (antigen), allowing us to immunize more people in a timely manner. The addition of the adjuvant substance helps the body develop good protection (also known as an immune response) against the pandemic H1N1 infection. How many components are in the adjuvanted H1N1 vaccine?
[ Back to H1N1 vaccine safety, adjuvants and thimerosal ] What is an adjuvant?An adjuvant is a substance added to a vaccine to help boost the immune response and increase protection. Adjuvants make it possible to reduce the amount of antigen per dose or the total number of doses needed to achieve immunity. Are adjuvants safe?Adjuvants are substances that are added to vaccines to help the body develop good protection/ immune response against pandemic H1N1 infection. Using an adjuvant means a smaller amount of the vaccine can be given with each injection. In early June, World Health Organization (WHO) held a consultation of experts which reviewed the safety of adjuvants. No significant safety concerns were identified in this consultation. Vaccine safety – including adjuvanted and non-adjuvanted vaccine - will be carefully monitored through post-marketing surveillance. What type of adjuvant is used in the H1N1 vaccine?The adjuvant AS03 is a trade name for a squalene-based immunologic substance used in pandemic influenza A H1N1 vaccine and other various vaccine products by GlaxoSmithKline. What is squalene?Squalene is a naturally occurring substance found in plants, animals, and humans. It is manufactured in the liver of every human body and circulates in our bloodstream. Squalene is commercially extracted from fish oil, and in particular shark liver oil. Squalene used in pharmaceutical products and vaccines is purified from this source. What is known about the safety of squalene in vaccines?Twenty two million doses of Chiron's influenza vaccine (FLUAD) have been administered safely since 1997. This vaccine contains about 10mg of squalene per dose. No severe adverse events have been associated with the vaccine. Some mild local reactions (redness, swelling, pain) have been observed and disappeared in 24 to 48 hours. Clinical studies on squalene-containing vaccines have been done in infants and neonates without evidence of safety concerns. As stated in the Product Information Leaflet, shark-derived squalene is highly purified. The purification process involves three successive distillation steps at more than 120 C°. This means that any protein present would have been eliminated in the process. Individuals allergic to fish would be allergic to a protein and not to any oil from the fish. Furthermore, squalene itself is naturally present in the human body. Why is AS03-adjuvant included in GlaxoSmithKline’s H1N1 vaccine?Available clinical data have shown that an oil-in-water adjuvanted vaccine can help mount a robust response against possible pandemic viruses such as the H5N1 and H1N1 influenza viruses. For this reason, GlaxoSmithKline has chosen an adjuvant formulation because a smaller amount of antigen is needed for each dose of vaccine produced (dose sparing) as its preferred option for its pandemic influenza vaccines. Canada supported the World Health Organization recommendation to use adjuvanted influenza vaccine to protect Canadians. Which countries are currently using vaccine with AS03 adjuvant?GlaxoSmithKline’s AS03 adjuvanted H5N1 pre-pandemic influenza vaccine is approved in all 27 European states, Malaysia and Hong Kong. This vaccine was developed for stockpiling by governments in advance of avian influenza and currently GlaxoSmithKline is not aware of clinical use of this vaccine in these regions. Will there be a non-adjuvanted vaccine available?Yes. GlaxoSmithKline is developing an non-adjuvanted H1N1 vaccine as recommended by the World Health Organization. The Public Health Agency of Canada has ordered a small quantity of non-adjuvanted vaccine, which will be available in Ontario early in November. Does the H1N1 vaccine contain the preservative, thimerosal?Yes. After mixing the contents of the AS03 adjuvant emulsion with the virus antigen suspension, each 0.5mL dose of the vaccine contains thimerosal, a mercury derivative (5μg per dose), as preservative. In line with World Health Organization’s guidelines, a preservative is necessary in multi-dose vials and thimerosal remains the most effective preservative. Will a single dose, thimerosal free format be available?No there will not be a thimerosal free H1N1 -2009 vaccine. Is there latex in the stoppers of the vials?The stopper is made of butyl rubber, and is latex free. Is there anything available for those with severe hypersensitivity to eggs?No, there is no H1N1 vaccine currently available for those with a severe hypersensitivity to eggs. Because the vaccine is manufactured in eggs, people with a documented severe hypersensitivity to eggs should not be vaccinated with the H1N1 vaccine. If they developed swelling of the mouth or throat, hives, or trouble breathing after a previous influenza vaccination they should consult with their health care provider. Is the vaccine inactivated?Yes, it is made from “killed” viruses. Does thimerosal cause autism or other neurodevelopmental disorders?The best available science to date has shown that there is no link between vaccines containing thimerosal and autism or other behaviour disorders. The National Advisory Committee on Immunization (NACI) has reviewed the safety of thimerosal and concluded that the alleged adverse health effect from thimerosal in vaccines has never been substantiated. “There is no legitimate safety reason to avoid the use of thimerosal-containing products for children or older individuals, including pregnant women.” International bodies, such as the World Health Organization (WHO), the U.S. Food and Drug Administration (U.S. FDA) and the Institute of Medicine in the U.S., share this opinion. Why is there discussion about Guillain-Barré Syndrome?In January and February 1976, a new strain of influenza A of swine origin appeared among military personnel on a military base at Fort Dix, New Jersey. Although the strain of influenza did not spread beyond the base and cases ceased within a few weeks, in October 1976 officials began a mass immunization campaign to prevent the circulation of this New Jersey strain. In total, 45 million doses of vaccine were administered in the United States between October and December 1976. The program was stopped when it was realized that 500 cases of Guillain-Barré Syndrome (GBS) had arisen after vaccination, resulting in 25 deaths. It was estimated that in the 6 to 8 weeks after vaccination, vaccinated individuals had a 4 to 8 times increased risk of GBS compared to non-vaccinated individuals. It is estimated that slightly less than 1 in 100,000 vaccinated people developed GBS in 1976. The cause of this increased risk was never determined. 1 In subsequent vaccination seasons, studies have shown either a non-existent risk of GBS after influenza vaccine or an increased risk of approximately 1 per 1,000,000 doses of influenza vaccine administered.7 To ensure its safety with respect to rare diseases such as Guillain-Barré Syndrome, post-marketing reporting of adverse events following receipt of the H1N1 influenza vaccine will be monitored closely. What is Guillain-Barré Syndrome?Guillain-Barré Syndrome (GBS) is a rapidly evolving, bilateral, ascending flaccid motor paralysis, with variable sensory changes. The prognosis is generally good, although some patients require mechanical ventilation and some fatalities occur, particularly in the elderly. It is a relatively rare condition that occurs at a rate of ~1-2 / 100,000; the incidence increases with age. GBS is believed to be immune mediated and results due to the production of antibodies that cross react with the peripheral nerve. In about two-thirds of cases, it occurs after a bacterial or viral infection such as Campylobacter jejuni, Mycoplasma pneumonia, HIV, Epstein-Barr virus, cytomegalovirus or possibly influenza infection itself. Pregnant womenShould pregnant women take special precautions to protect themselves, such as avoiding crowds? Should pregnant women take special precautions to protect themselves, such as avoiding crowds?It's important that people continue their daily lives during the pandemic. It is not recommended that pregnant women avoid going to work, or community social events if they are healthy. In other crowded situations that cannot be avoided, all people including pregnant women should take precautions such as frequent hand hygiene, to avoid picking up the virus. Pregnant women might consider carrying hand sanitizer for the same purpose. What type of vaccine (adjuvanted or non-adjuvanted) is recommended for pregnant women?All pregnant women with pre-existing health conditions and healthy pregnant women in the second half of their pregnancy (more than 20 weeks gestation) should speak to their health care provider about receiving the adjuvanted vaccine. Healthy pregnant women in the first half of their pregnancy are at less risk of complications from the flu, and can wait to receive the unadjuvanted vaccine, when it is available. Does an adjuvanted vaccine pose a risk to pregnant women?All evidence suggests that adjuvanted vaccines are just as safe as non-adjuvanted vaccines; however, there is no safety data for the use of adjuvanted vaccine in pregnant women. The WHO's Strategic Advisory Group of Experts (SAGE) recommended in July that pregnant women should receive non-adjuvanted vaccine where possible, but that an adjuvanted vaccine could be used if necessary in situations when local pandemic influenza activity is increasing. What is Ottawa Public Health recommending to pregnant women at this time?As H1N1 is spreading rapidly in Ontario, in Canada and elsewhere in North America, all pregnant women with pre-existing health conditions and healthy pregnant women in the second half of their pregnancy (more than 20 weeks gestation) should speak to their health care provider about receiving the adjuvanted vaccine. Healthy pregnant women in the first half of their pregnancy are at less risk of complications from the flu, and can wait to receive the non-adjuvanted vaccine, when it is available. As further information becomes available, and when non-adjuvanted vaccine is approved for use in Canada, these recommendations will be updated. AntiviralsWhat is the difference between an influenza antiviral and a vaccine? What is the difference between an influenza antiviral and a vaccine?Antivirals are drugs used for the prevention and early treatment of influenza. If taken shortly after getting sick (within 48 hours), they can reduce influenza symptoms, shorten the length of illness and may reduce serious complications from influenza infection. Antivirals work by reducing the ability of the virus to reproduce but do not provide immunity against the virus. The H1N1 flu virus can be treated with two different antivirals, oseltamivir (Tamiflu) and zanamivir (Relenza). A vaccine is any preparation intended to produce immunity to a disease by stimulating the production of antibodies. Vaccines are the best way to prevent illness and death from influenza. They stimulate the production of antibodies against the flu virus components included in the vaccine, providing immunity against the virus. In order to provide the best protection, a vaccine must be tailored to fight off specific strains of influenza. Should I take an antiviral now just in case I catch the new virus?No. You should only take an antiviral, such as oseltamivir or zanamivir, if your health care provider advises you to do so. Individuals should not buy medicines to prevent the H1N1 flu virus without a prescription, and they should be careful about buying antivirals over the internet. The vaccine is the best option to prevent you from becoming ill with the flu. Seasonal flu versus H1N1 vaccineWill this year’s seasonal influenza vaccine also protect against the H1N1 virus? Will this year’s seasonal influenza vaccine also protect against the H1N1 virus?No, having been immunized with this year’s seasonal influenza vaccine will not provide protection against the H1N1 virus, but it will provide protection against circulating seasonal influenza viruses. Can the seasonal influenza vaccine and the H1N1 vaccine be given at the same time? Can the H1N1 vaccine be given at the same time as other vaccines?The H1N1 vaccine may be administered concurrently with seasonal influenza vaccine or other vaccines. If H1N1 influenza vaccine is administered at the same time as both seasonal influenza and pneumococcal vaccines, the latter two should be given in the arm opposite that used for the H1N1 influenza vaccine, due to the higher frequency of local reactions to the adjuvanted H1N1 vaccine. Can I get the H1N1 vaccine if I have already had the seasonal influenza vaccine?Yes, you may receive the H1N1 vaccine after the seasonal influenza vaccine. If not given concurrently, there is no minimum interval required between the two influenza vaccines. If you got the H1N1 vaccine first, you may receive the seasonal vaccine after. The seasonal influenza vaccine will protect only against the seasonal influenza virus. To be protected from the H1N1 virus you must be immunized with the H1N1 vaccine. Travel questionsIs it safe to travel? Is it safe to travel?Yes. The World Health Organization is not recommending travel restrictions related to the outbreak of the H1N1 virus. Today, global travel is commonplace and large numbers of people move around the world for business and leisure. Limiting travel and imposing travel restrictions would have very little effect on stopping the virus from spreading, but would be highly disruptive to the global community. The H1N1 virus has already been confirmed in many parts of the world. The global response now focuses on minimizing the impact of the virus through the rapid identification of cases, and providing patients with appropriate medical care, rather than on stopping its spread internationally. How can I protect myself from H1N1 when I am travelling?People who are ill should delay travel plans. Returning travellers who become ill should contact their health care provider. |
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