Iv Vaccine Preparations Authorized For Use In Canada: Additional Information
The following sections describe information on the efficacy and effectiveness, immunogenicity, and safety of influenza vaccines that are authorized for use in Canada by type: IIV and LAIV. Refer to Appendix A for a summary of the characteristics of specific influenza vaccine products available in Canada for the 2020-2021 season.
NACI acknowledges that evidence related to influenza vaccine performance, particularly with respect to vaccine efficacy and effectiveness, is constantly evolving with advances in research methodology and accumulation of data over many influenza seasons. Therefore, the evidence summarized in this section may not include the latest studies. However, in accordance with usual practice, NACI continues to closely monitor the emerging evidence on the efficacy and effectiveness, immunogenicity, and safety of influenza vaccines to update and to make recommendations when warranted.
What Are Some Things I Need To Know Or Do While I Take Fluzone High
- Tell all of your health care providers that you take Fluzone High-Dose ). This includes your doctors, nurses, pharmacists, and dentists.
- If you have a latex allergy, talk with your doctor.
- If you are allergic to eggs, talk with the doctor.
- This medicine may not protect all people who use it. Talk with the doctor.
- This medicine is a vaccine with a virus that is not active. It cannot cause the disease.
- This medicine is not a cure for the flu. It must be given before you are exposed to the flu in order to work. Most of the time, it takes a few weeks for Fluzone High-Dose ) to work.
- This medicine only protects you for 1 flu season. You will need to get the flu vaccine each year.
- Not all brands of vaccines are for all children. Talk with your child’s doctor.
- Some children may need to have more than 1 dose of this vaccine. Talk with your child’s doctor.
- Some children have had a fever and seizures caused by fevers with some flu vaccines. Most of the time, this happened in children younger than 5 years of age. Fever has also been seen in children 5 to younger than 9 years of age. Talk with your child’s doctor.
- Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
Mild Side Effects Of Fluzone High
Below we describe mild side effects* of both Fluzone High-Dose Quadrivalent and Fluzone Quadrivalent. Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or dont go away, talk with your doctor or pharmacist.
Mild side effects of both Fluzone High-Dose Quadrivalent and Fluzone Quadrivalent in adults can include:
- feeling tired or unwell
- muscle aches
- pain, redness, or swelling at the injection site
* The list above is a partial list of mild side effects from Fluzone High-Dose Quadrivalent and Fluzone Quadrivalent. To learn about other mild side effects, talk with your doctor or pharmacist, or visit the prescribing information for Fluzone High-Dose Quadrivalent influenza vaccine and Fluzone Quadrivalent influenza vaccine.
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What Do I Need To Tell My Doctor Before I Take Fluzone High
- If you are allergic to Fluzone High-Dose ) any part of Fluzone High-Dose ) or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
This medicine may interact with other drugs or health problems.
Tell your doctor and pharmacist about all of your drugs and health problems. You must check to make sure that it is safe for you to take Fluzone High-Dose ) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Sanofi: Positive Results From The First Study Of High
Positive results from the first study of high-dose influenza vaccine with a COVID-19 mRNA booster support co-administration recommendations
- First study to investigate the safety and immunogenicity of both vaccines when co-administered compared to each vaccine administered separately in adults aged 65 years and older
- Timely new data for the start of the influenza vaccination campaigns across the Northern Hemisphere
7 October 2021
Interim results from the first co-administration descriptive study of Sanofis Fluzone® High-Dose Quadrivalent vaccine with Modernas COVID-19 mRNA investigational booster dose show that the administration of the vaccines at the same visit had similar immunogenicity responses and a similar safety and tolerability profile compared to each vaccine administered individually.
Fluzone® High-Dose Quadrivalent is a high-dose quadrivalent influenza vaccine, indicated for adults aged 65 and older in the United States and Canada. It is also licensed under the brand name Efluelda® in Europe where it is indicated for adults aged 60 and older. Fluzone High-Dose is the only influenza vaccine that has demonstrated reductions in influenza-related complications such as hospitalizations due to cardiovascular events and pneumonia, over 10 consecutive seasons in more than 34 million people aged 65 and older1,2,3.
About the study
About Fluzone® High-Dose Quadrivalent/ Efluelda®
Media Relations Contact
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To 2022 Seasonal Influenza Vaccine: Mobile Guide For Health Professionals
Important notice: This guidance is based on currently available scientific evidence and expert opinion. The content will be reviewed regularly and updates will be made as necessary throughout the influenza season as the public health context evolves and new evidence emerges.
The following is a summary of recommendations from the National Advisory Committee on Immunization .
Side Effects And Risks
Fluzone and Fluad can cause very similar side effects, but some different ones as well. Below are examples of these side effects.
Mild side effects
These lists contain up to 10 of the most common mild side effects that can occur with each vaccine, or with both Fluzone and Fluad when theyre used individually.
- Can occur with Fluzone:
get a flu vaccine thats appropriate for their age during flu season. The CDC doesnt state a preference for one influenza vaccine product over another.
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Fluzone Generic Or Biosimilar
Fluzone is a biologic drug thats available only as a brand-name medication. It doesnt come in a biosimilar form.
A biologic drug is made from living cells, while other drugs are made from chemicals. Drugs made from chemicals can have generics, which are exact copies of the active drug in the brand-name medication. Biologics, on the other hand, cant be copied exactly. Therefore, instead of a generic, biologics have biosimilars. Biosimilars are similar to the parent drug, and theyre considered to be just as effective and safe.
Like generics, biosimilars are often less expensive compared with brand-name medications.
What Is Fluzone Quadrivalent Southern Hemisphere
Fluzone Quadrivalent Southern Hemisphere is a form of Fluzone thats meant to be used in people located in the Southern Hemisphere.
Many different strains of influenza virus circulate each flu season. And these strains are continuously changing. Different strains of influenza are responsible for causing the flu across the globe.
Each year, scientists try to determine which strains of influenza will be the most common in the upcoming flu season. Then these strains are put into flu vaccines such as Fluzone. Different parts of the world can be affected by different strains of influenza during flu season. So different flu vaccines are made for use in different parts of the world.
If you have questions about which flu vaccine you should receive based on your location, talk with your doctor or pharmacist.
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Northern Hemisphere Influenza Season
The composition of trivalent virus vaccines for use in the 2017â2018 Northern Hemisphere influenza season recommended by the Advisory Committee on Immunization Practices on August 25, 2017, was:
- an A/Michigan/45/2015 pdm09âlike virus
- an A/Hong Kong/4801/2014 -like virus
- a B/Brisbane/60/2008âlike virus
In addition to these components, quadrivalent vaccines will also include a B/Phuket/3073/2013âlike virus .
In California, some emergency systems were strained by a spike in H3N2 flu cases. In addition, some areas experienced local shortages of oseltamivir. The severity of the flu season seemed somewhat comparable to the 2009â10 swine flu outbreak. A February 2018 CDC interim report estimated the vaccine effectiveness to be 25% against H3N2, 67% against H1N1, and 42% against influenza B.
Iii2 People Capable Of Transmitting Influenza To Those At High Risk Of Influenza
People who are potentially capable of transmitting influenza to those at high risk should receive annual vaccination, regardless of whether the high-risk individual has been vaccinated. Vaccination of HCWs decreases their own risk of illnessFootnote 52,Footnote 53, as well as the risk of death and other serious outcomes among the individuals for whom they provide careFootnote 54,Footnote 55,Footnote 56,Footnote 57. Vaccination of HCWs and residents of nursing homes is associated with decreased risk of ILI outbreaksFootnote 58.
People who are more likely to transmit influenza to those at high risk of influenza-related complications or hospitalization include:
- HCWs and other care providers in facilities and community settings who, through their activities, are capable of transmitting influenza to those at high risk and
- Contacts, both adults and children, of individuals at high risk, whether or not the individual at high risk has been vaccinated.
Health care workers and other care providers in facilities and community settings
Vaccination of health care workers and other care providers
Outbreak management in health care facilities
Contacts of individuals at high risk of influenza complications
Iii1 People At High Risk Of Influenza
All pregnant women
NACI recommends the inclusion of all pregnant women, at any stage of pregnancy, among the particularly recommended recipients of IIV, due to the risk of influenza-associated morbidity in pregnant womenFootnote 25,Footnote 26,Footnote 27,Footnote 28,Footnote 29, evidence of adverse neonatal outcomes associated with maternal respiratory hospitalization or influenza during pregnancyFootnote 30,Footnote 31,Footnote 32,Footnote 33, evidence that vaccination of pregnant women protects their newborns from influenza and influenza-related hospitalizationFootnote 34,Footnote 35,Footnote 36,Footnote 37, and evidence that infants born during influenza season to vaccinated women are less likely to be premature, small for gestational age, and of low birth weight than if born to women that had not received an influenza vaccineFootnote 38,Footnote 39,Footnote 40,Footnote 41. The risk of influenza-related hospitalization increases with length of gestation .
Refer to the Statement on Seasonal Influenza Vaccine for 2011-2012 and the Statement on Seasonal Influenza Vaccine for 2012-2013 for further details on influenza vaccination during pregnancy.
Adults and children with chronic health conditions
Neurologic or neurodevelopment conditions
People of any age who are residents of nursing homes and other chronic care facilities
Adults 65 years of age and older
All children 6-59 months of age
Evidence Behind The High
A study published in The Lancet Infectious Diseases Journal found the high-dose vaccine to be 22 percent more effective than the standard dose vaccine for flu prevention among people 65 and older. Additionally, the study showed a significant reduction in flu-related hospital admissions among those who were administered the high-dose vaccine.
Fishbein adds, âHigh-dose vaccines are recommended for people 65 and older because their immune systems are weaker and they are more likely to die from flu. High-dose vaccines contain more flu proteins called antigens. This means that there are more of the vaccine ingredients in order for the body to create a stronger antibody response. A higher dose is necessary for people 65 and older because they comprise the majority of flu hospitalizations.â
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So It Offers More Protection From The Flu
Exactly. A 2014 study published in The New England Journal of Clinical Medicine, which involved more than 30,000 adults aged 65 and older, found that participants who received the high-dose flu vaccine had 24% fewer flu illnesses compared to those who got the standard flu vaccine.
Another study, carried out during the 2013-2014 flu season and published in The Lancet Respiratory Medicine in 2017, found that the high-dose flu shot was associated with a lower risk of hospital admissions compared with the regular flu shot in people age 65 and over. This was particularly true for those living in long-term care facilities.
Will Getting Fluzone Make Me Get The Flu
No. Flu vaccines that are given with a needle, such Fluzone, contain inactivated influenza virus. Inactivated viruses arent live, so they wont make you sick.
When you get an inactivated flu vaccine, your immune system gets exposed to the inactivated flu virus. This prompts your immune system to make antibodies against the strains of flu contained in the vaccine. Once you have antibodies to the flu, if youre exposed to it, your body will be more prepared to fight it off.
On the other hand, the nasal flu vaccine, called FluMist, is made using a weakened form of a live flu virus. The live virus contained in FluMist can only reproduce and spread at cool temperatures, such as those found in your nose. It cant spread infection to your lungs, for example. So when the virus is contained to your nose, it shouldnt cause a flu infection in your body.
But its possible that FluMist may cause side effects that are similar to symptoms caused by the flu. These side effects, which may occur for up to a few days after you get FluMist, include:
- runny nose
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How Safe Is Fluzone High
Some side effects were reported more frequently after vaccination with trivalent Fluzone High-Dose than after standard-dose inactivated flu vaccines. The most common side effects experienced during clinical studies were mild and temporary, and included pain, redness at the injection site, headache, muscle aches, and malaise. Most people had minimal or no side effects after receiving the Fluzone High-Dose. In a study comparing Fluzone High-Dose Quadrivalent with trivalent Fluzone High-Dose, some of these side effects were slightly more common with the quadrivalent vaccine, but most were mild and resolved within a few days.
Ii5 Choice Of Seasonal Influenza Vaccine
The decision to include specific influenza vaccines as part of publicly funded provincial and territorial programs depends on several factors, such as cost-effectiveness evaluation and other programmatic and operational factors, such as implementation strategies. Not all products will be made available in all jurisdictions and availability of some products may be limited therefore, officials in individual provinces and territories should be consulted regarding the products available in individual jurisdictions.
With the availability of influenza vaccines that are designed to enhance immunogenicity in specific age groups or given through a different route of administration, the choice of product has become more complex.
Choice of influenza vaccine by age group
Recommendations for individual-level decision making
- NACI recommends that influenza vaccine should be offered annually to anyone 6 months of age and older who does not have contraindications to the vaccine. Table 2 provides age group-specific recommendations for the age-appropriate influenza vaccine types authorized for use in Canada.
Recommendations for public health program-level decision making
- NACI recommends that any of the age-appropriate influenza vaccine types available for use may be considered for people without contraindications to the vaccine. Table 2 provides age group-specific recommendations for the age-appropriate influenza vaccine types authorized in Canada.
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Trivalent And Quadrivalent Shots Made With Adjuvant
These shots, called Fluad and Fluad Quadrivalent, are another option for flu vaccines that are approved for people ages 65 and older. It includes an ingredient called adjuvant, which also creates a stronger immune system response.
These flu vaccines are slightly different because they protect against four different strains of the flu virus .
Because of this, these vaccinations can provide broader protection from infection.
Options are below.
Are Quadrivalent Flu Vaccines Safe
Yes. Flu vaccines that protect against four flu viruses have a safety profile similar to seasonal flu vaccines made to protect against three viruses, with similarmostly mildside effects. Like all seasonal flu vaccines, vaccines that protect against four flu viruses are monitored annually for their safety and effectiveness.
Quadrivalent vaccine cannot cause flu illness because they contain inactivated virus, attenuated virus, or are made using recombinant methods that dont use flu virus in the manufacturing process.
For information about flu vaccine side effects, see Can the flu vaccine give me the flu?
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Live Attenuated Influenza Vaccines
LAIV is approved for use only in persons aged 249 years who do not have underlying medical conditions. The vaccine should, however, not be administered to pregnant women. LAIV is given as a nasal spray, 1 dose only but children aged 28 years who have not received seasonal influenza vaccine during the previous influenza season should receive 2 doses, at least 4 weeks apart.
LAIV is made from attenuated, or weakened, viruses and does not cause influenza, although it can cause mild signs or symptoms . Most common side effects from the vaccine are mild and transient compared to symptoms of influenza infection.
Table 1 Influenza Vaccines United States 202021 Influenza Season*
|Trade name||HA or virus count for each vaccine virus||Route|
|Standard dose, cell culture based|
|High dose, egg based|
|Fluzone High-Dose Quadrivalent|
|Standard dose, egg based with MF59 adjuvant|
|Standard dose, egg based with MF59 adjuvant|
|0.2-mL prefilled single-use intranasal sprayer||2 through 49 yrs||106.5-7.5 fluorescent focus units/0.2 mL||NAS|
Abbreviations: ACIP = Advisory Committee on Immunization Practices FDA = Food and Drug Administration HA = hemagglutinin IIV3 = inactivated influenza vaccine, trivalent IIV4 = inactivated influenza vaccine, quadrivalent IM = intramuscular LAIV4 = live attenuated influenza vaccine, quadrivalent MDV = multidose vial NAS = intranasal PFS = prefilled syringe RIV4 = recombinant influenza vaccine, quadrivalent SDV = single-dose vial.
* Vaccination providers should consult FDA-approved prescribing information for 202021 influenza vaccines for the most complete and updated information, including indications, contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccinesexternal icon. Availability and characteristics of specific products and presentations might change and/or differ from what is described in this table and in the text of the full report.
§ The dose volume for Afluria Quadrivalent is 0.25 mL for children aged 6 through 35 months and 0.5 mL for persons aged 3 years.
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