How Does A High
Fluzone High-Dose Quadrivalent contains four times the amount of antigen as the regular dose flu vaccine. As we get older, our immune systems have a harder time fighting off infections and learning from vaccines. The higher amount of antigen in the high-dose flu vaccine helps an older adults immune system better recognize and react to the vaccine.
The influenza strains and inactive ingredients in Fluzone High-Dose are the same as Fluzone Quadrivalent one of the available regular dose flu vaccines. However, a few other regular dose flu vaccines are available which vary more from the high-dose vaccine than Fluzone Quadrivalent.
The following are other FDA-approved flu vaccines for the 2021/2022 flu season and how they differ from the high-dose flu vaccine:
Iii2 Efficacy And Effectiveness
Four studies comparing the relative efficacy of high dose vaccines were identified and described below.
The relative efficacy of Fluzone®High Dose compared with Fluzone® has been evaluated in two studies to date. The first study of 9158 ambulatory, medically-stable adults 65 years and older was conducted in 2009-2010 during the H1N1 pandemicFootnote 21. The relative efficacy was 12.5% in favour of Fluzone®High Dose against laboratory-confirmed influenza, but with exceedingly wide confidence bounds in this study 21 of the 22 symptomatic cases of influenza were caused by the Apdm09 strain, which was not in the seasonal vaccine.
The second study was conducted in 2011-2012 and 2012-2013 Footnote 22. In this study of almost 32,000 older adults, 18-24% fewer illnesses caused by influenza occurred in people who received Fluzone®High Dose compared with those who received Fluzone®. The relative efficacy against laboratory-confirmed influenza of the high dose vaccine compared to the standard dose vaccine was 18% in participants who provided swabs when they had an acute respiratory illness, with 2.0% and 2.4%, respectively, diagnosed with influenza. The relative efficacy against laboratory-confirmed influenza was 24% , with 1.4% and 1.9%, respectively, diagnosed with influenza, in those who provided swabs when they had an influenza-like illness ).
Should I Get The High
People younger than 65 can receive the high-dose vaccine, but there are caveats.
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Q. If the high-dose flu vaccine is more potent, why do I have to wait until Im 65 to get it?
A. People younger than 65 can receive the high-dose vaccine, but there are caveats.
Because older people have a weaker immune response to influenza vaccine than younger people do and are at increased risk for hospitalization and death from flu, the Food and Drug Administration approved a high-dose flu vaccine, called Fluzone High-Dose, in 2009, but only for those 65 and older.
Fluzone High-Dose contains four times as much immune-stimulating antigen as the standard-dose vaccine does. As a result, it produces significantly higher antibody levels in those who receive it.
In a rigorous post-licensure safety and efficacy study mandated by the F.D.A., Fluzone High-Dose was about 24 percent more effective than standard-dose vaccine in preventing influenza among older recipients. More important, it appears to reduce the serious cardiopulmonary complications of influenza, including pneumonia and worsening of heart failure and chronic obstructive pulmonary disease in the elderly.
Since the evidence suggests that younger people would also benefit from the high-dose vaccine, why is it restricted to older people?
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When To Get The Flu Shot
Flu season typically runs from late fall to early spring.
Flu shots are now available for all Ontarians. You should get a flu shot as soon as possible because it takes two weeks to take effect.
The National Advisory Committee on Immunization now recommends that COVID-19 vaccines may be given at the same time as the flu vaccine.
Talk to your doctor or pharmacy to learn more.
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.
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Should I Get A Flu Shot
Yes! An annual flu vaccine is the best way to protect yourself against influenza. Flu vaccines are very safe and help lower the risk of severe illness and death due to the flu. Thats why an annual flu vaccine is recommended for everyone over the age of 6 months, including pregnant people and people with weakened immune systems.
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.
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Iii3 Serological Criteria For Assessment Of Influenza Vaccines
A common measure of immunogenicity is to assess the level of serum antibodies produced in response to antigens included in the vaccine through a laboratory test called a hemagglutination inhibition assay. Seroconversion is measured as the proportion of participants with a minimum of a four-fold increase from pre- to post-immunization titres . Seroprotection is a measure of the proportion of participants with a HI titre of 1:40 post-vaccination Footnote 26 and is generally accepted as being correlated with a 50% reduction in the risk of influenza Footnote 27. The geometric mean titre is the geometric mean of the participants’ serum antibodies. The geometric mean fold rise is the ratio of the post-vaccination/pre-vaccination serum anti-haemagglutinin antibody titres.
When comparing two vaccines, there are two commonly used assessments: 1) the geometric mean titre ratio , which uses the ratio of the post-vaccination GMT of people receiving each vaccine, and 2) the difference in the proportion of people who seroconvert in each group Footnote 27.Non-inferiority of a new vaccine when comparing it to a licensed vaccine requires that: 1) the ratio of the post-vaccine GMT has an upper-bound of 2-sided 95% confidence interval of < 1.5 , and 2) the difference in seroconversion rates has an upper bound of 2-sided 95% CI of < 10 percentage points.
Table 1: Criteria for assessment of seasonal influenza vaccines for adults 60 years and older
| Committee |
|---|
| Meets both |
Types Of Flu Shots For People 65 And Older
People 65 years and older should get a flu shot, not a nasal spray vaccine. They can get any flu vaccine approved for use in their age group with no preference for any one vaccine over another. There are regular flu shots that are approved for use in people 65 years and older and there also are two vaccines designed specifically for this age group:
High Dose and Adjuvanted Flu Vaccine Side Effects
The high dose and adjuvanted flu vaccines may result in more of the temporary, mild side effects that can occur with standard-dose seasonal flu shots. Side effects can include pain, redness or swelling at the injection site, headache, muscle ache and malaise, and typically resolve with 1 to 3 days.
Recombinant Vaccine
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Who Needs To Get A High
Fluzone High-Dose Quadrivalent is only FDA-approved for people over 65, so if youre younger than that, you should stick to the regular dose vaccine. Speak with your healthcare provider to decide which available flu vaccine is the best option for you.
If youre over 65 and questioning your flu vaccines options, contact your healthcare provider. Theyll let you know which of the three CDC-recommended flu vaccines for people over 65 is the best for you.
If your pharmacy or healthcare providers office doesnt have high-dose flu vaccines in stock, its recommended to get vaccinated with a regular dose vaccine instead of waiting for Fluzone High-Dose Quadrivalent to be restocked. A regular dose vaccine will still offer you protection against the flu.
Iv2 Types Of Vaccines Compared
There are no studies, at present, to compare the efficacy or effectiveness of 60g HA/strain inactivated intramuscular influenza vaccine to 1) 15g HA/strain inactivated intramuscular influenza vaccine containing an adjuvant, or 2) 15g HA/strain inactivated intradermal vaccine. Since these vaccines are manufactured specifically for use in older adults, a head-to-head comparison would be informative for decision-makers. Only one study compared the immune responses of older adults vaccinated with 60g HA/strain to those vaccinated with 15g HA/strain intradermal vaccine and none have compared the immunogenicity of the 60g HA/strain product to 15g HA/strain intramuscular influenza vaccine containing an adjuvant.
There are also no studies that compare any of these vaccines with the quadrivalent influenza vaccines. Although a previous review found similar immune responses and safety profiles for inactivated quadrivalent compared with inactivated trivalent influenza vaccines in older adults, no studies have assessed the efficacy or effectiveness of the quadrivalent vaccines in seniors.
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What We Know About Covid
Q: How are COVID-19 and influenza similar and how are they different?
A: COVID-19 and influenza have many similarities, but also many differences.
The main similarities are:
- Both viruses are mostly spread through an airborne route. This means that steps you take to protect yourself from COVID-19, such as social distancing measures and avoiding crowded indoor spaces, will likely reduce your risk of catching influenza as well.
- The initial symptoms of infection have a lot in common. Namely, both often start with upper respiratory symptoms such as cough, runny nose, fatigue, fever, and body aches. This means it will be difficult to tell the two conditions apart, unless laboratory testing is used.
- Both are more likely to cause severe illness in people who are older or frail.
Even though both viruses often cause viral pneumonia, there are significant differences between the two. They are actually quite different types of viruses. The differences include:
In short, influenza and COVID-19 are similar in terms of how they spread and common initial symptoms. But COVID-19 has so far caused more serious disease, and at this time, remains harder to treat, in part because it seems to affect the body in more significant ways than influenza usually does.
For more on the similarities and differences between influenza and COVID-19:
Q: Is it possible to get influenza and COVID-19 at the same time? How do they affect each other?
Getting Tiv Getting The Flu
With more than a doubling of the vaccination rate since 1990, one would expect a healthy drop in flu-related hospitalizations and deaths. But those numbers havent dropped. In fact, overall hospital admission and death rates in the U.S. have actually increased over the last two decades, even after accounting for changing age demographics and ups and downs in this customized vaccines effectiveness against each seasons new flu strain.
The actual life- and health-sparing value of flu vaccine in the elderly has been a subject of some controversy. Nearly all the evidence for protective benefit in this population comes from non-randomized observational studies. Typical of these was a large 2003 medical record review of 286,000 community-dwelling Americans at least 65 years old. In this review, those who got a flu vaccine experienced nearly a 20 percent reduction in risk of hospitalization for cardiac disease, about a 30 percent lower risk of hospitalization for pneumonia or influenza, and an impressive 49 percent average reduction in risk of death from all causes over the span of two flu seasons.
This obvious bias is built into any study that simply tallies deaths or hospitalizations of people who decided on their own whether to get a flu shot. People who choose on their own to get the vaccine clearly tend to be much healthier than those who dont, and they appear to take better care of themselves when they do get sick.
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Are There Benefits Of Fluzone High
Data from clinical trials comparing Fluzone to Fluzone High-Dose among people 65 years and older indicated that a stronger immune response occured after vaccination with Fluzone High-Dose. A study published in the New England Journal of Medicineexternal icon indicated that the high-dose vaccine was 24% more effective in preventing flu in adults 65 years and older relative to a standard-dose vaccine. Another study published in The Lancet Respiratory Medicineexternal icon reported that people 65 years and older who got Fluzone High-dose had a lower risk of hospital admission compared with people in that age group who got the standard-dose Fluzone, especially those living in long-term care facilities. This study was conducted during the 2013-14 flu season among more than 38,000 resident of 823 nursing homes in 38 states.
For the 2021-22 season, all Fluzone High-Dose vaccine will be quadrivalent. Data comparing the effectiveness of Fluzone High-Dose Quadrivalent with standard-dose inactivated quadrivalent vaccines are not yet available.
Who Can Receive Fluzone High
In the United States, Fluzone High-Dose Quadrivalent is licensed only for people 65 years and older. Fluzone High-Dose Quadrivalent is not recommended for people with a history of severe allergic reaction to the vaccine or to ingredients other than eggs. Information about vaccine ingredients is located in package inserts from each manufacturer.
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What To Know About Flu Shots For Older Adults
Q: Is the flu vaccine effective for older adults?
A: You may have heard people say that the flu shot doesnt work in older people. This is not entirely correct.
Now, its true that flu vaccine is usually less effective in older adults because aging immune systems tend to not respond as vigorously to the vaccine. In other words, older adults tend to create fewer antibodies in response to vaccination. So if they are later exposed to flu virus, they have a higher chance of falling ill, compared to younger adults.
But less effective doesnt mean not at all effective. For the 2017-2018 flu season, the CDC estimates that vaccination prevented about 700,000 influenza cases and 65,000 hospitalizations, for adults aged 65 and older.
For more on the effectiveness of influenza vaccination in older adults, see:
To provide more effective vaccination to aging immune systems, vaccine makers have developed stronger vaccines against the flu, which I explain in the next section.
Q: Are there flu shots specifically designed for older adults?
Yes, over the past several years, vaccine makers have developed vaccines that are designed to work better with an aging immune system. Most research studies to date show that these stimulate aging immune systems to produce more antibodies to influenza. Theres also some evidence that these vaccines reduce the risk of being hospitalized for influenza.
Which Influenza Vaccination Is Best For Older Adults
Looking at the list of available flu shots can be overwhelming. In looking at this years CDC table of available influenza vaccines, I counted eight options that are available for people aged 65 or older:
- 4 standard-dose quadrivalent inactivated vaccines
- 1 standard-dose quadrivalent inactivated vaccine manufactured with a newer cell culture-based technology
- 1 high-dose quadrivalent inactivated vaccine
- 1 standard-dose quadrivalent adjuvanted inactivated vaccine
- 1 quadrivalent recombinant vaccine
Only Fluzone High-Dose Quadrivalent and Fluad Quadrivalent carry an age indication specific to 65 years or older.
However, the CDC does not recommend any influenza vaccine over another, for adults aged 65 or older.
So if you are an older adult, or if youre trying to arrange a flu shot for an aging relative, which flu vaccine should you try to get?
My take is this: if you have a choice, go for one of the vaccines designed for older adults.
Why? Because we know that as people get older, their immune systems tend to respond less vigorously to immunization. And because research suggests that the high-dose flu shot generates higher antibody titers and has been associated with better influenza outcomes.
We do have more research and experience for Fluzone High-Dose than for Fluad, so unless you are enrolling in a clinical trial of Fluad, I would suggest going with the Fluzone High-Dose.
Bottom line:
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This Flu Seasons New Arrival: Fluzone High
For the first time since the flu vaccines introduction in the 1940s, Americans aged 65 and older will have the option of receiving a high-potency flu vaccine during the current 2010-2011 season. Last Decembers FDA approval of Sanofi Pasteurs Fluzone High-Dose proves once again that sometimes successful ideas also are the simplest ones. Instead of the 15 micrograms of each of the three hemagglutinin viral surface antigens included in standard TIV preparations, Fluzone HD delivers 60 mcg – four times as much – in the same 0.5 mL dose for intramuscular injection. A different colored syringe plunger distinguishes it from regular Fluzone provided in a prefilled syringe. Everything else about the two products is the same. Immunogenicity findings from three clinical trials in persons 65 years of age and older demonstrate that Fluzone HD elicits substantially higher hemagglutinin inhibition titers than the standard dose. In the largest of these studies, the mean post-vaccination antibody titer elicited by Fluzone HD against the A/H1NI, A/H3N2 and B flu strains was 70 percent, 80 percent and 30 percent higher, respectively, than the titer elicited by the standard-dose vaccine. Additional important evidence of the enhanced immunogenicity of Fluzone HD is revealed by comparative seroconversion and seroprotection findings, as summarized in Table 2.