Professional Documents
Culture Documents
Influenza vaccine
Vaccine description
Clinical data
AHFS/ Inactivated: Monograph Intranasal: Monograph Recom
Drugs.com
binant: Monograph
Pregnancy AU: B1/B2[1][2]
category
Routes of Intramuscular, intranasal, intradermal
administratio
n
J07BB04 (WHO)
Legal status
UK: POM (Prescription only)
US: ℞-only
EU: Rx-only
Identifiers
CAS 1704512-59-3
Number
ChemSpider none
KEGG D04536
Contents
1History
o 1.1Origins and development
o 1.2Acceptance
o 1.3Quadrivalent vaccines for seasonal flu
2Medical uses
o 2.1Effectiveness
o 2.2Children
o 2.3Adults
o 2.4Elderly
o 2.5Pregnancy
3Safety
o 3.1Side effects
o 3.2Guillain–Barré syndrome
o 3.3Egg allergy
o 3.4Other
4Types
5Recommendations
o 5.1World Health Organization
o 5.2Canada
o 5.3European Union
o 5.4United States
o 5.5United Kingdom
o 5.6Australia
6Uptake
o 6.1At risk groups
o 6.2Health care workers
7Manufacturing
o 7.1Egg-based
o 7.2Other methods of manufacture
o 7.3Vaccine manufacturing countries
8Cost-effectiveness
9Research
o 9.1Rapid response to pandemic flu
o 9.2Universal flu vaccines
o 9.3Oral influenza vaccine
o 9.4COVID-19
o 9.5Criticism
10Veterinary use
o 10.1Horses
o 10.2Poultry
o 10.3Pigs
o 10.4Dogs
11Annual reformulation
o 11.12020–2021 northern hemisphere
o 11.22021 southern hemisphere
o 11.32021–2022 northern hemisphere
o 11.42022 southern hemisphere
o 11.52022–2023 northern hemisphere
12Notes
13See also
14References
15Further reading
16External links
History[edit]
See also: Timeline of vaccines
Vaccines are used in both humans and nonhumans. Human vaccine is meant unless
specifically identified as a veterinary, poultry or livestock vaccine.
Origins and development[edit]
In the worldwide Spanish flu pandemic of 1918, "Pharmacists tried everything they
knew, everything they had ever heard of, from the ancient art of bleeding patients,
to administering oxygen, to developing new vaccines and serums (chiefly against
what we now call Hemophilus influenzae – a name derived from the fact that it was
originally considered the etiological agent – and several types of pneumococci). Only
one therapeutic measure, transfusing blood from recovered patients to new victims,
showed any hint of success."[25]
In 1931, viral growth in embryonated hens' eggs was reported by Ernest William
Goodpasture and colleagues at Vanderbilt University. The work was extended to
growth of influenza virus by several workers, including Thomas Francis, Jonas Salk,
Wilson Smith and Macfarlane Burnet, leading to the first experimental influenza
vaccines.[26] In the 1940s, the US military developed the first approved inactivated
vaccines for influenza, which were used in the Second World War. [27] Hen's eggs
continued to be used to produce virus used in influenza vaccines, but manufacturers
made improvements in the purity of the virus by developing improved processes to
remove egg proteins and to reduce systemic reactivity of the vaccine. [28] In 2012, the
US Food and Drug Administration (FDA) approved influenza vaccines made by
growing virus in cell cultures[29][30][31] and influenza vaccines made from recombinant
proteins[32] have been approved, with plant-based influenza vaccines being
tested[when?] in clinical trials.[33]
Acceptance[edit]
The egg-based technology for producing influenza vaccine was created in the 1950s.
[34]
In the US swine flu scare of 1976, President Gerald Ford was confronted with a
potential swine flu pandemic. The vaccination program was rushed, yet plagued by
delays and public relations problems. Meanwhile, maximum military containment
efforts succeeded unexpectedly in confining the new strain to the single army base
where it had originated. On that base, a number of soldiers fell severely ill, but only
one died. The program was canceled after about 24% of the population had received
vaccinations. An excess in deaths of 25 over normal annual levels as well as 400
excess hospitalizations, both from Guillain–Barré syndrome, were estimated to have
occurred from the vaccination program itself, demonstrating that the vaccine itself is
not free of risks. The result can be cited to support lingering doubts about
vaccination as well as to counter ungrounded claims about the safety of vaccination.
[35]
In the end, however, even the maligned 1976 vaccine may have saved lives. A
2010 study found a significantly enhanced immune response against the 2009
pandemic H1N1 in study participants who had received vaccination against the
swine flu in 1976.[36]
Quadrivalent vaccines for seasonal flu[edit]
Preparation of the flu vaccine for sailors serving aboard the USS Gerald R. Ford in 2019
A quadrivalent flu vaccine administered by nasal mist was approved by the FDA in
March 2012.[37][38] Fluarix Quadrivalent was approved by the FDA in December 2012. [39]
In 2014, the Canadian National Advisory Committee on Immunization (NACI)
published a review of quadrivalent influenza vaccines. [40]
Starting with the 2018–2019 influenza season most of the regular-dose egg-based
flu shots and all the recombinant and cell-grown flu vaccines in the United States are
quadrivalent.[41] In the 2019–2020 influenza season all regular-dose flu shots and all
recombinant influenza vaccine in the United States are quadrivalent. [42]
In November 2019, the FDA approved Fluzone High-Dose Quadrivalent for use in
the United States starting with the 2020–2021 influenza season. [43][44]
In February 2020, the FDA approved Fluad Quadrivalent for use in the United
States.[45][46] In July 2020, the FDA approved both Fluad and Fluad Quadrivalent for
use in the United States for the 2020–2021 influenza season. [45][47]
Medical uses[edit]
The U.S Centers for Disease Control and Prevention (CDC) recommends the flu
vaccine as the best way to protect people against the flu and prevent its spread.
[48]
The flu vaccine can also reduce the severity of the flu if a person contracts a strain
that the vaccine did not contain.[48] It takes about two weeks following vaccination for
protective antibodies to form.[48][49]
A 2012 meta-analysis found that flu vaccination was effective 67 percent of the time;
the populations that benefited the most were HIV-positive adults aged 18 to 55
(76 percent), healthy adults aged 18 to 46 (approximately 70 percent), and healthy
children aged six months to 24 months (66 percent).[50] The influenza vaccine also
appears to protect against myocardial infarction with a benefit of 15–45%.[51]
Effectiveness[edit]
US vaccine effectiveness (%) against symptomatic disease.[52][53][54][55][56] Notes: unestimable for the 2020–21
flu season,[57] data missing for seasons 1999–2000 to 2002–03.
children who died "likely will not have been vaccinated". [80]
In the United States, as of January 2019, the CDC recommend that children aged six
through 35 months may receive either 0.25 milliliters or 0.5 milliliters per dose
of Fluzone Quadrivalent.[42][81] There is no preference for one or the other dose volume
of Fluzone Quadrivalent for that age group. [42] All persons 36 months of age and older
should receive 0.5 milliliters per dose of Fluzone Quadrivalent. [42] As of October 2018,
Afluria Quadrivalent is licensed for children six months of age and older in the United
States.[42][82] Children six months through 35 months of age should receive
0.25 milliliters for each dose of Afluria Quadrivalent. [42] All persons 36 months of age
and older should receive 0.5 milliliters per dose of Afluria Quadrivalent.[42] As of
February 2018, Afluria Tetra is licensed for adults and children five years of age and
older in Canada.[83]
In 2014, the Canadian National Advisory Committee on Immunization (NACI)
published a review of influenza vaccination in healthy 5–18-year-olds, [84] and in 2015,
published a review of the use of pediatric Fluad in children 6–72 months of age. [85] In
one study, conducted in a tertiary referral center, the rate of influenza vaccination in
children was only 31%. Higher rates were found among immuno-suppressed
pediatric patients (46%), and in patients with inflammatory bowel disease (50%). [86]
Adults[edit]
In unvaccinated adults, 16% get symptoms similar to the flu, while about 10% of
vaccinated adults do.[11] Vaccination decreased confirmed cases of influenza from
about 2.4% to 1.1%.[11] No effect on hospitalization was found.[11]
In working adults, a review by the Cochrane Collaboration found that vaccination
resulted in a modest decrease in both influenza symptoms and working days lost,
without affecting transmission or influenza-related complications. [11] In healthy working
adults, influenza vaccines can provide moderate protection against virologically
confirmed influenza, though such protection is greatly reduced or absent in some
seasons.[12]
In health care workers, a 2006 review found a net benefit. [87] Of the eighteen studies
in this review, only two also assessed the relationship of patient mortality relative to
staff influenza vaccine uptake; both found that higher rates of health care worker
vaccination correlated with reduced patient deaths. [87] A 2014 review found benefits to
patients when health care workers were immunized, as supported by moderate
evidence[88] based in part on the observed reduction in all-cause deaths in patients
whose health care workers were given immunization compared with comparison
patients where the workers were not offered vaccine. [89]
Elderly[edit]
Evidence for an effect in adults over 65 is unclear.[90] Systematic reviews examining
both randomized controlled and case–control studies found a lack of high-quality
evidence.[12][13] Reviews of case–control studies found effects against laboratory-
confirmed influenza, pneumonia, and death among the community-dwelling elderly. [91]
[92]
The group most vulnerable to non-pandemic flu, the elderly, benefits least from the
vaccine. There are multiple reasons behind this steep decline in vaccine efficacy, the
most common of which are the declining immunological function and frailty
associated with advanced age.[93] In a non-pandemic year, a person in the United
States aged 50–64 is nearly ten times more likely to die an influenza-associated
death than a younger person, and a person over 65 is more than ten times more
likely to die an influenza-associated death than the 50–64 age group. [94]
There is a high-dose flu vaccine specifically formulated to provide a stronger immune
response.[95] Available evidence indicates that vaccinating the elderly with the high-
dose vaccine leads to a stronger immune response against influenza than the
regular-dose vaccine.[96][97][98]
A flu vaccine containing an adjuvant was approved by the US Food and Drug
Administration (FDA) in November 2015, for use by adults aged 65 years of age and
older. The vaccine is marketed as Fluad in the US and was first available in the
2016–2017 flu season. The vaccine contains the MF59C.1 adjuvant[99] which is an oil-
in-water emulsion of squalene oil. It is the first adjuvanted seasonal flu vaccine
marketed in the United States.[100][101][102] It is not clear if there is a significant benefit for
the elderly to use a flu vaccine containing the MF59C.1 adjuvant. [103][104][105] Per Advisory
Committee on Immunization Practices guidelines, Fluad can be used as an
alternative to other influenza vaccines approved for people 65 years and older. [101]
Vaccinating health care workers who work with elderly people is recommended in
many countries, with the goal of reducing influenza outbreaks in this vulnerable
population.[106][107][108] While there is no conclusive evidence from randomized clinical
trials that vaccinating health care workers helps protect elderly people from
influenza, there is tentative evidence of benefit. [109]
Fluad Quad was approved for use in Australia in September 2019, [110] Fluad
Quadrivalent was approved for use in the United States in February 2020, [45] and
Fluad Tetra was approved for use in the European Union in May 2020. [111]
Pregnancy[edit]
As well as protecting mother and child from the effects of an influenza infection, the
immunization of pregnant women tends to increase their chances of experiencing a
successful full-term pregnancy.[112]
The trivalent inactivated influenza vaccine is protective in pregnant women infected
with HIV.[113]
Safety[edit]
See also: Vaccine controversies
Side effects[edit]
Common side effects of vaccination include local injection-site reactions and cold-
like symptoms. Fever, malaise, and myalgia are less common. Flu vaccines are
contraindicated for people who have experienced a severe allergic reaction in
response to a flu vaccine or to any component of the vaccine. LAIVs are not given to
children or adolescents with severe immunodeficiency or to those who are using
salicylate treatments because of the risk of developing Reye syndrome.[66] LAIVs are
also not recommended for children under the age of 2, [67] pregnant women, and
adults with immunosuppression. Inactivated flu vaccines cannot cause influenza and
are regarded as safe during pregnancy.[66]
While side effects of the flu vaccine may occur, they are usually minor, including
soreness, redness, and swelling around the point of injection, headache, fever,
nausea or fatigue.[114] Side effects of a nasal spray vaccine may include runny nose,
wheezing, sore throat, cough, or vomiting.[115]
In some people, a flu vaccine may cause serious side effects, including an allergic
reaction, but this is rare. Furthermore, the common side effects and risks are mild
and temporary when compared to the risks and severe health effects of the
annual influenza epidemic.[48]
Guillain–Barré syndrome[edit]
Although Guillain–Barré syndrome had been feared as a complication of vaccination,
the CDC states that most studies on modern influenza vaccines have seen no link
with Guillain–Barré.[116][117] Infection with influenza virus itself increases both the risk of
death (up to one in ten thousand) and the risk of developing Guillain–Barré
syndrome to a far higher level than the highest level of suspected vaccine
involvement (approximately ten times higher by 2009 estimates). [118][119]
Although one review gives an incidence of about one case of Guillain–Barré per
million vaccinations,[120] a large study in China, covering close to a hundred million
doses of vaccine against the 2009 H1N1 "swine" flu found only eleven cases of
Guillain–Barré syndrome, (0.1 per million doses) total incidence in persons
vaccinated, actually lower than the normal rate of the disease in China, and no other
notable side effects.[119][121]
Egg allergy[edit]
Fresh eggs being prepared for influenza vaccine production at Instituto Butantan
Types[edit]
Main article: List of seasonal influenza vaccines
Flu vaccines are available either as:[citation needed]
Recommendations[edit]
Various public health organizations, including the World Health Organization (WHO),
recommend that yearly influenza vaccination be routinely offered, particularly to
people at risk of complications of influenza and those individuals who live with or
care for high-risk individuals, including:
Pregnant women
Second priority (in no particular order):
A young woman displays her bandage after receiving the vaccine at a drug store.
In the United States routine influenza vaccination is recommended for all persons
aged six months and over.[19][148] It takes up to two weeks after vaccination for sufficient
antibodies to develop in the body.[148] The CDC recommends vaccination before the
end of October,[19] although it considers getting a vaccine in December or even later
to be still beneficial.[19][48][148]
According to the CDC, the live attenuated virus (LAIV4) (which comes in the form of
the nasal spray in the US) should be avoided by some groups. [19][149]
Within its blanket recommendation for general vaccination in the United States, the
CDC, which began recommending the influenza vaccine to health care workers in
1981, emphasizes to clinicians the special urgency of vaccination for members of
certain vulnerable groups, and their caregivers:
Vaccination is especially important for people at
higher risk of serious influenza complications or
people who live with or care for people at higher risk
for serious complications.[150] In 2009, a new high-
dose formulation of the standard influenza vaccine
was approved.[151] The Fluzone High Dose is
specifically for people 65 and older; the difference is
that it has four times the antigen dose of the
standard Fluzone.[152][153][154][155]
The US government requires hospitals to report worker
vaccination rates. Some US states and hundreds of US
hospitals require health care workers to either get
vaccinations or wear masks during flu season. These
requirements occasionally engender union lawsuits on
narrow collective bargaining grounds, but proponents
note that courts have generally endorsed forced
vaccination laws affecting the general population during
disease outbreaks.[156]
Vaccination against influenza is especially considered
important for members of high-risk groups who would be
likely to have complications from influenza, for example
pregnant women[19][157] and children and teenagers from
six months to 18 years of age who are receiving aspirin-
or salicylate-containing medications and who might be
at risk for experiencing Reye syndrome after influenza
virus infection;[19]
Uptake[edit]
Vaccination rate in the OECD, 2018 or latest[164]
Australia Oceania 75
Chile Americas 65
Netherlands Europe 64
Canada Americas 61
Portugal Europe 61
Israel Asia 58
Ireland Europe 58
Spain Europe 54
Italy Europe 53
Denmark Europe 52
Japan Asia 50
France Europe 50
Sweden Europe 49
Finland Europe 48
Iceland Europe 45
Luxembourg Europe 38
Germany Europe 35
Norway Europe 34
Hungary Europe 27
Slovenia Europe 12
Latvia Europe 8
Turkey Asia 7
Estonia Europe 5
At risk groups[edit]
Uptake of flu vaccination, both seasonally and during
pandemics, is often low.[165] Systematic reviews of
pandemic flu vaccination uptake have identified several
personal factors that may influence uptake, including
gender (higher uptake in men), ethnicity (higher in
people from ethnic minorities) and having a chronic
illness.[166][167] Beliefs in the safety and effectiveness of the
vaccine are also important.[165]
A number of measures have been found to be useful to
increase rates of vaccination in those over sixty
including: patient reminders using leaflets and letters,
postcard reminders, client outreach programs, vaccine
home visits, group vaccinations, free vaccinations,
physician payment, physician reminders and
encouraging physician competition.[168]
Health care workers[edit]
Frontline health care workers are often recommended to
get seasonal and any pandemic flu vaccination. For
example, in the UK all health care workers involved in
patient care are recommended to receive the seasonal
flu vaccine, and were also recommended to be
vaccinated against the H1N1/09 (later renamed
A(H1N1)pdm09[note 1][169]) swine flu virus during the 2009
pandemic. However, uptake is often low.[137] During the
2009 pandemic, low uptake by healthcare workers was
seen in countries including the UK,[137] Italy,[170] Greece,
[171]
and Hong Kong.[172]
In a 2010 survey of United States health care workers,
63.5% reported that they received the flu vaccine during
the 2010–11 season, an increase from 61.9% reported
the previous season. US Health professionals with
direct patient contact had higher vaccination uptake,
such as physicians and dentists (84.2%) and nurse
practitioners (82.6%).[173][174][175]
The main reason to vaccinate health care workers is to
prevent staff from spreading flu to their patients and to
reduce staff absence at a time of high service demand,
but the reasons health care workers state for their
decisions to accept or decline vaccination may more
often be to do with perceived personal benefits. [137]
In Victoria (Australia) public hospitals, rates of health
care worker vaccination in 2005 ranged from 34% for
non-clinical staff to 42% for laboratory staff. One of the
reasons for rejecting vaccines was concern over
adverse reactions; in one study, 31% of resident
physicians at a teaching hospital incorrectly believed
Australian vaccines could cause influenza.[176]
Manufacturing[edit]
Australia
Brazil
Canada
China
France
Germany
Hungary
India
Iran
Japan
Mexico
Netherlands
Nicaragua
Russian Federation
South Korea
United Kingdom
United States
Vietnam
In addition, Kazakhstan, Serbia and Thailand had
facilities in final stages of establishing production. [200]
Cost-effectiveness[edit]
The cost-effectiveness of seasonal influenza vaccination
has been widely evaluated for different groups and in
different settings.[201] In the elderly (over 65), the majority
of published studies have found that vaccination is cost
saving, with the cost savings associated with influenza
vaccination (e.g. prevented health care visits)
outweighing the cost of vaccination.[202] In older adults
(aged 50–64 years), several published studies have
found that influenza vaccination is likely to be cost-
effective, however the results of these studies were
often found to be dependent on key assumptions used
in the economic evaluations.[203] The uncertainty in
influenza cost-effectiveness models can partially be
explained by the complexities involved in estimating the
disease burden,[204] as well as the seasonal variability in
the circulating strains and the match of the vaccine. [205]
[206]
In healthy working adults (aged 18–49 years), a 2012
review found that vaccination was generally not cost-
saving, with the suitability for funding being dependent
on the willingness to pay to obtain the associated health
benefits.[207] In children, the majority of studies have
found that influenza vaccination was cost-effective,
however many of the studies included (indirect)
productivity gains, which may not be given the same
weight in all settings.[208] Several studies have attempted
to predict the cost-effectiveness of interventions
(including prepandemic vaccination) to help protect
against a future pandemic, however estimating the cost-
effectiveness has been complicated by uncertainty as to
the severity of a potential future pandemic and the
efficacy of measures against it.[209]
Research[edit]
Influenza research includes molecular
virology, molecular evolution, pathogenesis,
host immune responses, genomics, and epidemiology.
These help in developing influenza countermeasures
such as vaccines, therapies and diagnostic tools.
Improved influenza countermeasures require basic
research on how viruses enter cells, replicate, mutate,
evolve into new strains and induce an immune
response. The Influenza Genome Sequencing Project is
creating a library of influenza sequences[210] that will help
researchers' understanding of what makes one strain
more lethal than another, what genetic determinants
most affect immunogenicity, and how the virus evolves
over time. Solutions to limitations in current[when?] vaccine
methods are being[when?] researched.
A different approach uses Internet content to estimate
the impact of an influenza vaccination campaign. More
specifically, researchers have used data
from Twitter and Microsoft's Bing search engine, and
proposed a statistical framework which, after a series of
operations, maps this information to estimates of the
influenza-like illness reduction percentage in areas
where vaccinations have been performed. The method
has been used to quantify the impact of two flu
vaccination programmes in England (2013/14 and
2014/15), where school-age children were administered
a live attenuated influenza vaccine (LAIV). Notably, the
impact estimates were in accordance with estimations
from Public Health England based on traditional
syndromic surveillance endpoints.[211][212]
Rapid response to pandemic flu[edit]
The rapid development, production, and distribution of
pandemic influenza vaccines could potentially save
millions of lives during an influenza pandemic. Due to
the short time frame between identification of a
pandemic strain and need for vaccination, researchers
are looking at novel technologies for vaccine production
that could provide better "real-time" access and be
produced more affordably, thereby increasing access for
people living in low- and moderate-income countries,
where an influenza pandemic may likely originate, such
as live attenuated (egg-based or cell-based) technology
and recombinant technologies (proteins and virus-like
particles).[213] As of July 2009, more than seventy known
clinical trials have been completed or are ongoing for
pandemic influenza vaccines.[214] In September 2009, the
FDA approved four vaccines against the 2009 H1N1
influenza virus (the 2009 pandemic strain), and
expected the initial vaccine lots to be available within
the following month.[215]
In January 2020, the US Food and Drug
Administration (FDA) approved Audenz as a vaccine for
the H5N1 flu virus.[216] Audenz is a vaccine indicated for
active immunization for the prevention of disease
caused by the influenza A virus H5N1 subtype
contained in the vaccine. Audenz is approved for use in
persons six months of age and older at increased risk of
exposure to the influenza A virus H5N1 subtype
contained in the vaccine.[217]
Universal flu vaccines[edit]
Main article: Universal flu vaccine
A "universal vaccine" that would not have to be
designed and made for each flu season in each
hemisphere would stabilize the supply, avoid error in
predicting the season's variants, and protect against
escape of the circulating strains by mutation.[177] Such a
vaccine has been the subject of research for decades. [218]
One approach is to use broadly neutralizing
antibodies that, unlike the annual seasonal vaccines
used over the first decades of the 21st century
that provoke the body to generate an immune response,
instead provide a component of the immune response
itself. The first neutralizing antibodies were identified in
1993, via experimentation.[219] It was found that the flu
neutralizing antibodies bound to the stalk of the
Hemagglutinin protein. Antibodies that could bind to the
head of those proteins were identified. The highly
conserved M2 proton channel was proposed as a
potential target for broadly neutralizing antibodies. [218][220]
The challenges for researchers are to identify single
antibodies that could neutralize many subtypes of the
virus, so that they could be useful in any season, and
that target conserved domains that are resistant
to antigenic drift.[218]
Another approach is to take the conserved domains
identified from these projects, and to deliver groups of
these antigens to provoke an immune response; various
approaches with different antigens, presented different
ways (as fusion proteins, mounted on virus-like
particles, on non-pathogenic viruses, as DNA, and
others), are under development.[220][221][222]
Efforts have also been undertaken to develop universal
vaccines that specifically activate a T-cell response,
based on clinical data showing that people with a
strong, early T-cell response have better outcomes
when infected with influenza and because T-cells
respond to conserved epitopes. The challenge for
developers is that these epitopes are on internal protein
domains that are only mildly immunogenic.[220]
Along with the rest of the vaccine field, people working
on universal vaccines have experimented with vaccine
adjuvants to improve the ability of their vaccines to
create a sufficiently powerful and enduring immune
response.[220][223]
Oral influenza vaccine[edit]
As of 2019, an oral flu vaccine was in clinical research.
[224]
The oral vaccine candidate is based on
an adenovirus type 5 vector modified to remove genes
needed for replication, with an added gene that
expresses a small double-stranded RNA hairpin
molecule as an adjuvant.[225] In 2020, a Phase II human
trial of the pill form of the vaccine showed that it was
well tolerated and provided similar immunity to a
licensed injectable vaccine.[226]
COVID-19[edit]
An influenza vaccine and a COVID-19 vaccine may be
given safely at the same time.[49][227] Preliminary research
indicates that influenza vaccination does not
prevent COVID-19, but may reduce the incidence and
severity of COVID-19 infection.[228]
Criticism[edit]
Tom Jefferson, who has led Cochrane
Collaboration reviews of flu vaccines, has called clinical
evidence concerning flu vaccines "rubbish" and has
therefore declared them to be ineffective; he has called
for placebo-controlled randomized clinical trials, which
most in the field hold as unethical. His views on the
efficacy of flu vaccines are rejected by medical
institutions including the CDC and the National Institutes
of Health, and by key figures in the field like Anthony
Fauci.[229]
Michael Osterholm, who led the Center for Infectious
Disease Research and Policy 2012 review on flu
vaccines, recommended getting the vaccine but
criticized its promotion, saying, "We have overpromoted
and overhyped this vaccine ... it does not protect as
promoted. It's all a sales job: it's all public relations." [230]
Veterinary use[edit]
See also: Influenza A virus and Influenza § Infection in
other animals
Veterinary influenza vaccination aims to achieve the
following four objectives:[231]
Annual reformulation[edit]
Further information: Historical annual reformulations of
the influenza vaccine
See also: 2009 flu pandemic vaccine
Each year, three strains are chosen for selection in that
year's flu vaccination by the WHO Global Influenza
Surveillance and Response System.[242] The chosen
strains are the H1N1, H3N2, and Type-B strains thought
most likely to cause significant human suffering in the
coming season. Starting with the 2012–2013 Northern
Hemisphere influenza season (coincident with the
approval of quadrivalent influenza vaccines), the WHO
has also recommended a 2nd B-strain for use in
quadrivalent vaccines. The World Health
Organization (WHO) coordinates the contents of the
vaccine each year to contain the most likely strains of
the virus to attack the next year.
"The WHO Global Influenza Surveillance Network
was established in 1952 [renamed "Global Influenza
Surveillance and Response System" in 2011]. [243] The
network comprises four WHO Collaborating Centres
(WHO CCs) and 112 institutions in 83 countries,
which are recognized by WHO as WHO National
Influenza Centres (NICs). These NICs collect
specimens in their country, perform primary virus
isolation and preliminary antigenic characterization.
They ship newly isolated strains to WHO CCs for
high level antigenic and genetic analysis, the result
of which forms the basis for WHO recommendations
on the composition of influenza vaccine for the
Northern and Southern Hemisphere each year." [244]
The Global Influenza Surveillance and Response
System's selection of viruses for the vaccine
manufacturing process is based on its best estimate
of which strains will predominate the next year,
amounting in the end to well-informed but fallible
guesswork.[245]
Formal WHO recommendations were first issued in
1973. Beginning in 1999 there have been two
recommendations per year: one for the northern
hemisphere and the other for the southern
hemisphere.[246]
Historical annual reformulations of the influenza
vaccine are listed in a separate article. Recent WHO
seasonal influenza vaccine composition
recommendations:
2020–2021 northern hemisphere[edit]
The composition of virus vaccines for use in the
2020–2021 Northern Hemisphere influenza season
recommended by the World Health Organization on
February 28, 2020, is:[247]
for egg-based:
an A/Guangdong-Maonan/SWL1536/2019
(H1N1)pdm09-like virus
an A/Hong Kong/2671/2019 (H3N2)-like virus
a B/Washington/02/2019 (B/Victoria lineage)-like
virus
a B/Phuket/3073/2013 (B/Yamagata lineage)-like
virus
for cell- or recombinant-based:[citation needed]
an A/Guangdong-Maonan/SWL1536/2019
(H1N1)pdm09-like virus;
an A/HongKong/2671/2019 (H3N2)-like virus;
a B/Washington/02/2019-like virus (B/Victoria
lineage);
a B/Phuket/3073/2013-like virus (B/Yamagata
lineage).
The committee recommended that the quadrivalent
formulation of cell- or recombinant-based influenza
vaccines for the US 2020–2021 influenza season
contain the following:[248]
an A/Guangdong-Maonan/SWL1536/2019
(H1N1)pdm09-like virus;
an A/Hong Kong/2671/2019 (H3N2)-like virus;
a B/Washington/02/2019 (B/Victoria lineage)-like
virus.
Cell-based trivalent vaccines should contain: [249]
an A/Wisconsin/588/2019 (H1N1)pdm09-like
virus;
an A/Hong Kong/45/2019 (H3N2)-like virus; and
a B/Washington/02/2019 (B/Victoria lineage)-like
virus.
The quadrivalent version should contain, in addition
to the above:
an A/Wisconsin/588/2019 (H1N1)pdm09-like
virus;
an A/Cambodia/e0826360/2020 (H3N2)-like
virus;
a B/Washington/02/2019 (B/Victoria lineage)-like
virus.
A B/Phuket/3073/2013-like virus is recommended in
addition to the strains mentioned above for the
quadrivalent vaccines.[252]
United States
The FDA Vaccines and Related Biological Products
Advisory Committee (VRBPAC) recommended that
the quadrivalent formulation of egg-based influenza
vaccines for the US 2021-2022 influenza season
contain the following:[254]
an A/Wisconsin/588/2019 (H1N1)pdm09-like
virus;
an A/Darwin/6/2021 (H3N2)-like virus;
a B/Austria/1359417/2021 (B/Victoria lineage)-
like virus; and
a B/Phuket/3073/2013 (B/Yamagata lineage)-like
virus.
United States
The FDA Vaccines and Related Biological Products
Advisory Committee (VRBPAC) recommended that
the quadrivalent formulation of egg-based influenza
vaccines for the U.S. 2022-2023 influenza season
contain the following:[259]
an A/Wisconsin/588/2019 (H1N1)pdm09-like
virus;
an A/Darwin/6/2021 (H3N2)-like virus;
a B/Austria/1359417/2021-like virus (B/Victoria
lineage); and
a B/Phuket/3073/2013-like virus (B/Yamagata
lineage).
For trivalent influenza vaccines for use in the US for
the 2022–2023 influenza season, depending on the
manufacturing method of the vaccine, the committee
recommended that the A(H1N1)pdm09, A(H3N2)
and B/Austria/1359417/2021-like virus (B/Victoria
lineage) viruses recommended above for the
quadrivalent vaccines be used.[259]
Notes[edit]
1. ^ (H1N1)pdm09 is newer nomenclature for the 2009
pandemic H1N1 virus, not a different strain.
See also[edit]
H5N1 vaccine
Seasonal influenza vaccine brands
Universal influenza vaccine
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Further reading[edit]
World Health Organization (October 2017). The
immunological basis for immunization series:
module 23: influenza vaccines. World Health
Organization (WHO). hdl:10665/259211. ISBN
978-9241513050.
Ramsay M (ed.). "Chapter 19:
Influenza". Immunisation against infectious
disease. Public Health England.
Hamborsky J, Kroger A, Wolfe S, eds.
(2015). "Chapter 12: Influenza". Epidemiology
and Prevention of Vaccine-Preventable
Diseases (13th ed.). Washington D.C.:
U.S. Centers for Disease Control and
Prevention (CDC). ISBN 978-0990449119.
Budd A, Blanton L, Grohskopf L, Campbell A,
Dugan V, Wentworth DE, et al. (March 29,
2019). "Chapter 6: Influenza". In Roush SW,
Baldy LM, Hall MA (eds.). Manual for the
surveillance of vaccine-preventable diseases.
Atlanta GA: U.S. Centers for Disease Control
and Prevention (CDC).
National Advisory Committee on Immunization
(May 2020). "Canadian Immunization Guide
Chapter on Influenza and Statement on
Seasonal Influenza Vaccine for 2020–
2021" (PDF). Public Health Agency of Canada.
Cat.: HP37-25F-PDF; Pub.: 200003. Lay
summary. {{cite web}}: Cite uses deprecated
parameter |lay-url= (help)
National Advisory Committee on Immunization
(NACI) (May 2018). NACI literature review on
the comparative effectiveness and
immunogenicity of subunit and split virus
inactivated influenza vaccines in adults 65 years
of age and older (PDF). Government of
Canada. ISBN 9780660264387. Cat.: HP40-
213/2018E-PDF; Pub.: 180039. Lay
summary. {{cite book}}: Cite uses deprecated
parameter |lay-url= (help)
Rajaram S, Wojcik R, Moore C, Ortiz de
Lejarazu R, de Lusignan S, Montomoli E, et al.
(August 2020). "The impact of candidate
influenza virus and egg-based manufacture on
vaccine effectiveness: Literature review and
expert consensus". Vaccine. 38 (38): 6047–
6056. doi:10.1016/j.vaccine.2020.06.021. PMID
32600916.
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