Influenza Immunization Reference Guide 2020-2021 - Public Health - Saskatchewan ...
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Source:SHA-Saskatoon Population and Public Health 2017
Influenza Immunization
Reference Guide
2020-2021
Public Health September 2020
1
Influenza Immunization Reference Guide
Table of Contents
Page #
Introduction ....................................................................................................................................... 3
Section One – Influenza Disease .............................................................................................. 4
Infectious Agent
Clinical Disease
Reservoir
Transmission
Incubation
Section Two – Influenza Vaccine .............................................................................................. 5
Influenza Program Dates
Vaccine composition
Publicly Funded Vaccine Products
Vaccine Ingredients
Recommended Vaccine Recipients
Vaccine Schedule and Dosage
Vaccine Effectiveness
Section Three – Management of Biological Products ................................................................ 10
Vaccine Storage and Principles
Cold Chain Break
Section Four –Vaccine Administration...................................................................................... 11
Informed Consent
Contraindications to Influenza Vaccine
Precautions to influenza Vaccine
General Screening Questions
10 Rights of Immunization
Immunization Sites
Vaccine preparation – multidose
Vaccine preparation – pre-filled syringes
Land marking
Positions and holds
Site preparation and administration
Post immunization
Section Five – Common Reactions and Adverse Events Following Immunization ...................... 17
Common Reactions
Rare Reactions
Guillain-Barré Syndrome (GBS)
Oculorespiratory Syndrome (ORS)
Anaphylaxis
Anaphylaxis vs Fainting and Anxiety Table
Section Six – Reporting Adverse Events Following Immunization (AEFI) .................................... 19
References ............................................................................................................................. 20
This Reference Guide is an accompaniment to the
Learning Module slides for Influenza Immunizers
available www.4flu.ca.
2
Influenza Immunization Reference Guide
Introduction
The Influenza program is implemented in accordance with the Saskatchewan Influenza Immunization Policy (SIIP).
All residents 6 months of age and older are eligible to receive publicly funded influenza vaccine. The
administration of publicly funded vaccine commences Oct 19 2020.
The influenza program objective is to prevent influenza disease and/or reduce complications and deaths among
Saskatchewan residents through vaccination.
To achieve this objective, Population and Public Health works in concert with multiple immunization partners in
the delivery of seasonal influenza vaccine.
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Influenza Immunization Reference Guide
Section One – Influenza Disease
Infectious Agent¹’²
• Influenza disease is a caused primarily by Influenza A and B viruses.
• Influenza A viruses are classified into subtypes based on two surface proteins hemagglutinin (HA) and
neuraminidase (NA).
• Influenza B viruses have evolved into two distinct lineages - B/Yamagata and B/Victoria.
• Over time, antigenic variation (antigenic drift) of strains occurs within an influenza A subtype or B lineage.
• The ever-present possibility of antigenic drift requires seasonal influenza vaccines to be reformulated
annually. Antigenic drift may occur in one or more influenza virus strains.³
• The World Health Organization (WHO) recommends the composition of the influenza virus vaccines twice
a year.
Clinical Disease¹
• Sudden onset of fever, cough, and muscle aches. Other symptoms - headache, chills, loss of appetite,
fatigue and sore throat. Nausea, vomiting, and diarrhea may occur, especially in kids.
• In general, only about 50% of infected persons will develop the classic clinical symptoms of influenza.⁴
• Respiratory illness that can cause mild to severe disease leading to hospitalization and death.
• Globally the attack rate is estimated at: 5-10% in adults and 20-30% in children.
• Most people will recover in 10 days, but some are at a greater risk for severe complications.
• Young children, older adults, and those with certain illnesses or risk factors have a higher risk for serious
complications, including viral pneumonia, secondary bacterial pneumonia and worsening of medical
conditions.
• Every year about 3,500 Canadians will die from influenza.
Reservoir
• Influenza A can infect human and other animal species – especially birds
• Influenza B limited to humans.
Transmission
• Spreads easily through droplet spread through coughing, sneezing, and direct/indirect contact with
respiratory secretions.
• Indirect contact from counters, door knobs and then touching your eyes, nose and mouth.
• Usually seasonal with higher rates in late fall and early winter.
• Can spread disease even if asymptomatic.
Incubation
• 2 days but can range from 1-4 days.
• Adults can spread the disease 1 day before symptom onset to approximately 5 days after the start of
symptoms
• Children may spread the virus for 10 days or longer³
For an explanation of Influenza Disease, watch the
video:
https://www.youtube.com/watch?v=yhhJfT86Bgg
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Influenza Immunization Reference Guide
Section Two – Influenza Vaccine
Influenza Program Dates
• Monday October 19, 2020 to Wednesday March 31, 2021
• 2nd dose for children
Influenza Immunization Reference Guide
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 vaccine.. The risk of
influenza-related hospitalization increases with length of gestation (i.e., it is higher in the third trimester
than in the second).¹
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Influenza Immunization Reference Guide
Table 1: 2020-21 Publicly Funded Influenza Vaccines
FluLaval® Tetra (GSK) FLUZONE® Quadrivalent (SP) FLUZONE® High Dose (SP)
QIV split virion QIV split virion TIV split virion
Population Everyone ≥ 6 months Everyone ≥ 6 months LTC residents ≥ 65 years
Dose 0.5 mL IM 0.5 mL IM 0.5 mL IM
Components Latex and antibiotic free and contains Latex, antibiotic and gelatin free and Latex, antibiotic, thimerosal and gelatin
both influenza A strains and B viral contains all surface antigens of this free and contains all surface antigens of
strains, sodium chloride, potassium year’s influenza A and B viral strains, this year’s influenza A strains and one B
chloride, disodium hydrogen formaldehyde, sodium phosphate- viral strain, formaldehyde, sodium
phosphate heptahydrate, potassium buffered, isotonic sodium chloride phosphate-buffered, isotonic sodium
dihydrogen phosphate, α-tocopheryl solution, and Triton® X-100, and may chloride solution, and Triton® X-100, and
hydrogen succinate, and polysorbate contain traces of egg protein and may contain traces of egg protein.
80, and may contain traces of egg sucrose.
proteins (ovalbumin), sodium
deoxycholate, ethanol, formaldehyde
and sucrose.
Preservative Thimerosal in multidose vials. Thimerosal in multidose vials. No preservatives
Normal and Pain (60%), redness (2%), and The most common reactions The most common reactions
Expected swelling (3%)at the injection site. occurring after vaccine occurring after vaccine
Reactions Mild
to moderate
Headache (22%), fever (2%), administration are injection site administration are injection site pain
tiredness (22%), muscle aches pain (11%-57%), erythema (7%- (36%), erythema (15%) and edema
reactions 30%) and edema (6%-21%). (9%).
(26%), and shivering (9%).
generally last 1-
4 days. Loss of appetite (9%) The most common systemic The most common systemic
reactions observed after reactions observed after vaccine
vaccine administration are administration includes myalgia
asthenia (2%-18%), headache (21%), malaise (18%) and (2%-18%),
(2%-10%) and myalgia (2%- headache (17%).
9%).
Presentation 5 mL multidose vial containing 10 5 mL multidose vial containing 10 0.5 mL prefilled syringes (thimerosal
doses of 0.5 mL doses of 0.5 mL free)
0.5 mL prefilled syringes
(thimerosal free)
Contra- Persons with a history of a severe allergic or anaphylactic reaction to a previous influenza vaccine dose or any
indications component of an influenza vaccine should discuss their situation with a public health nurse or their physician.
Persons who developed GBS within six weeks of a previous influenza vaccine.
Instructions for Do not administer vaccine from Vaccine may be administered Nothing specific for this vaccine.
Administration a vial that has been opened for from a MDV that has been
≥28 days or has expired. opened up to the expiry date
To get 10 doses out of a vial, indicated on the vial.
GSK recommends that each
0.5 mL dose is withdrawn into
a 1 mL syringe equipped with
a needle gauge not larger than
a 23G.
Special Gently shake pre-filled syringes or vials before administration
Instructions –
Store at 2°C-8°C
Do not freeze or use if vaccine has been frozen.
Pre-drawing is not recommended.
The Ministry recommends that vaccines be administered directly from the fridge or cooler and not warmed to
room temperature prior to administration.
Protect from light.
Date vials when opened.
Source: Table from the Saskatchewan Influenza Immunization Policy 2020 - 21: Appendix 1: 2020-2021 Publicly
Funded Influenza Vaccines (p.18)
NOTE: Thimerosal free vaccine is available for those who self-identify as having a diagnosed thimerosal allergy.
Contact the local Public Health office if requiring thimerosal free vaccine.
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Influenza Immunization Reference Guide
Table 2: Populations for Whom Influenza Vaccination is Particularly Recommended
Publicly funded influenza vaccines may be administered to people who are six months of age and
older who do not have vaccine contraindications. In particular, the following people are highly
recommended to receive the influenza vaccine to reduce the incidence and burden of influenza
disease and related health complications:
All HCWs, health care students, emergency response workers, visitors and volunteers who,
through their activities, are capable of transmitting influenza to those at high-risk of influenza
complications in independent practices, facilities, residences and community settings.
Adults (including pregnant women) and children ≥6 months with a chronic health condition including
but not limited to:
cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis &
asthma);
diabetes mellitus and other metabolic diseases;
cancer and other immune-compromising conditions (due to underlying disease, therapy or
both);
renal disease;anemia or hemoglobinopathies;
neurologic or neurodevelopment conditions (includes neuromuscular, neurovascular,
neurodegenerative, neurodevelopmental disorders and seizure disorders (and for children
include febrile seizures and isolated developmental delay) but excludes migraine and
psychiatric conditions without neurological conditions
morbid obesity (adult BMI ≥ 40, child BMI assessed as ≥ 95th percentile adjusted for sex and
age)
Children and adolescents with the following conditions:
Those undergoing treatment for long periods with acetylsalicylic acid, because of the potential
increase of Reye syndrome associated with influenza.
People of any age who are residents of nursing homes, long-term care facilities and other
chronic care facilities.
People ≥ 65 years of age.
All children six to 59 months of age (younger than five years).
Indigenous peoples.
Visitors to health care facilities and other patient care locations.
Household and close contacts of individuals at high-risk of influenza-related complications whether or
not the individual at high-risk has been immunized.
Household and close contacts of infants less than six months of age.
Members of households who are expecting a newborn during the influenza season.
Those providing regular child care to children ≤ 59 months of age, whether in or out of the home.
Those who provide services within closed or relatively closed settings to persons at high-risk.
People who provide essential community services (e.g., provincial corrections staff who have direct
contact with inmates).
People in direct contact during culling operations with poultry infected with avian influenza.
People working with live or dead poultry or swin e .
Health sciences students (human and animal health).
Travellers - Influenza occurs year-round in the tropics. In temperate northern and southern countries,
influenza activity peaks generally during the winter season (November to March in the Northern
Hemisphere and April to October in the Southern Hemisphere).
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Influenza Immunization Reference Guide
Vaccine Schedule and Dosing
Age Vaccine Dosage (mL) Number of doses
required per season
6 months to 8 years QIV 0.5 mL IM 1 or 2 *
≥ 9 years ≥ 65 years QIV 0.5 mL IM 1
(excludes residents of LTC and
personal care homes)
LTC and personal care home TIV (FLUZONE® High-Dose) 0.5 mL IM 1
residents ≥ 65 years or (QIV if TIV unavailable)
* Children 6 months to less than 9 years of age receiving seasonal influenza vaccine for the first time in their life
should be given 2 doses of influenza vaccine, with one month apart (minimum interval 4 weeks) between doses.
Children 6 months to less than 9 years of age who have been properly vaccinated with one or more doses of
seasonal influenza vaccine in the past should receive 1 dose of influenza vaccine per season thereafter.
Vaccine Effectiveness
• Influenza vaccine has been shown to provide protection against infection and illness. Effectiveness is
dependent on age, co-morbidities, and vaccine virus match to the circulating strains.
• Vaccine protective levels of humoral antibodies are generally achieved by 2 weeks after vaccination;
however, there may be some protection afforded before that time¹
• Fluzone High-Dose (IIV3-HD) provides superior protection compared with the standard trivalent
inactivated influenza vaccine in adults 65 years of age and older.
9Influenza Immunization Reference Guide
Section Three – Management of Biological Products
Vaccine Storage and Principles
• Vaccine must be maintained at a temperature between 2°C - 8°C during transport, storage and handling
of vaccines
• Vaccines are sensitive biological products which may become less effective, or even destroyed, when
exposed to temperatures outside the recommended range.
• Influenza vaccines when exposed to light may lose their effectiveness. Protect from light. Always keep
influenza vaccine in its original container (box).
• Vaccine that is frozen is no longer viable.
• Always store refrigerated biological products between 2°C and 8°C in a refrigerator for biological
products.
• Never use a bar or half-sized refrigerator for product storage.
• Do not keep food or drinks in vaccine refrigerator.
• Return products to fridge as quickly as possible to the fridge after use and on return from an off site
immunization clinic.
• Always use products with the nearest expiry date first.
• Ensure vaccine is not expired.
Understanding the principles of cold chain is a key concept in the handling and the storage of vaccines
Cold Chain Break
• If a cold chain break is suspected, immediately place implicated vaccine in a bag labeled “Cold Chain
Break - DO NOT USE”
• Return bag to fridge - maintaining the quarantined product under cold chain conditions.
• Follow the directions found in the Saskatchewan Influenza Immunization Policy 2020-2021
• Do not discard vaccine until the Ministry of Health determines the product integrity. Depending on
circumstances the Ministry of Health may allow the vaccine to be used.
10Influenza Immunization Reference Guide
Section Four – Vaccine Administration
Always use two identifiers to ensure you have the right client:
• First and last name
• Date of birth
• Health card number
• Verify client has not received influenza vaccine in the current seasonal influenza season (since October
19, 2020
Check eHR Viewer or Panorama to determine appropriate interval for 2nd dose influenza for
ChildrenInfluenza Immunization Reference Guide
National Advisory Committee on Immunization statement on Influenza vaccine 2017-2018:
NACI has concluded that egg allergic individuals may be vaccinated against influenza using any
appropriate product without prior influenza vaccine skin test and with the full dose, irrespective of a past
severe reaction to egg and without any particular consideration, including immunization setting.
Precautions
• Do not delay immunization because of minor acute illness, with or without fever.
• In the 2020-2021 Saskatchewan Influenza Immunization Policy (SIIP) it states, “Vaccine administration
should be postponed when possible in persons who have a minor or acute illness, with or without a
temperature based on current COVID-19 screening criteria, until their symptoms have abated.”
With the current COVID19 screening, the above recommendations are reflective of community
based settings (i.e. home visits, clinics). Clients that do not pass the COVID19 screening criteria
in the community setting will be asked to defer immunization.
• It is very important to provide inactive vaccines, to immunocompromised individuals, however the
magnitude and duration of vaccine – induced immunity are often reduced⁵
General Screening Question
• Are you well today?
• Do you have any severe allergies?
• Have you had a reaction to a previous vaccine that you were concerned about?
• Do you have any history of neurological issues (screening for Guillain-Barre Syndrome within 6 weeks of
receiving a flu vaccine)?
10 “Rights” of Immunization
When preparing any biological product ensure:
• Right client • Right dose*
• Right assessment • Right route*
• Right client education • Right time*
• Right to refuse • Right documentation
• Right product* • Right evaluation
* Check three times
Immunization Sites
• 6 months – 11 months
Site: Vastus Lateralis (mid lateral thigh)
Needle length: 1” (never 5/8”)
• 12 months and up
Site: Preferred site is deltoid (In a 12 month old if small muscle mass can use vastus lateralis)
Needle length: 1” (1.5 inch for heavier adolescents/adults)
12Influenza Immunization Reference Guide
NOTE:
• Influenza vaccine should not be administered into other sites.
• Injectable influenza vaccine doses must be administered IM to be considered valid. If given SC, repeat.
(Saskatchewan Immunization manual chapter 5)
Vaccine Preparation of multidose vial
• Date multi-dose vials upon opening. The first day that the stopper is punctured is considered “day 1”.
FluLaval Tetra® - Do not administer vaccine from a vial that has been opened for ≥ 28 days.
Fluzone® - May be used until the expiry date indicated on the vial.
• Cleanse the surface of the rubber stopper with alcohol and allow to dry.
• Gently swirl the vial immediately before removing each dose to ensure contents are fully dispersed.
• Hold/place the vial right side up and insert the needle through the centre of the rubber stopper. Do not
insert blunt needles with or without a filter into vials because of coring risk.
• Withdraw 0.5 ml of vaccine. Remove the excess WHILE in the vial. DO NOT spray it into the air.
• DO NOT withdraw contents from multiple vials to make a 0.5 ml vaccine dose.
• Return the vial to the box and refrigerate immediately or put back into cooler.
Pre-loading of syringes with Influenza vaccine is discouraged because of the uncertainty of product stability in
syringes, risk of contamination, increased potential for administration errors, and biological product wastage.
Vaccine Preparation of Pre-filled Syringe
• Gently shake the syringe to ensure there are no particles.
Screw on the appropriate 1” or 1.5”
• You do not need to remove the air in a pre-filled syringe.
13Influenza Immunization Reference Guide
Land marking
• Deltoid
• Vastus lateralis
• Inappropriate deltoid land marking
14Influenza Immunization Reference Guide
Positioning and Holds
15Influenza Immunization Reference Guide
Steps for preparing site and administering Influenza Vaccine
• Ensure good visualization of the injection site area and avoid tight clothing above the injection site.
• Position the client’s limb for injection. Swab the site of injection with alcohol swab and allow to dry (less
stinging).
• Select appropriate injection site:
6 months to < 1 year of age: Vastus lateralis (anterolateral thigh).
Clients ≥1 year of age: Deltoid (provided the muscle mass is adequate).
Single mastectomy clients – use arm opposite the mastectomy.
Double mastectomy clients - use vastus lateralis.
• Coach client to relax the limb muscles prior to injection.
• Secure the injection site using the appropriate stabilization technique for the client’s age.
• Insert the needle quickly at a 90° angle.
• Inject the vaccine rapidly – DO NOT aspirate.
• Withdraw needle quickly at the same angle it was inserted and apply gentle pressure with a cotton ball at
the injection site.
• Activate the safety engineered device immediately after withdrawing needle.
• Discard used syringe and needle as a single unit in sharps container.
• Empty multidose vials are to be disposed of in the sharps container.
Post Immunization
• Encourage the 15 minute wait post vaccination
• Counsel when to seek medical attention post-immunization
• Review management of potential side effects
• Provide all clients with the wallet card for their record of influenza vaccine.
16Influenza Immunization Reference Guide
Section 5 – Common Reactions and Adverse Events Following Influenza Immunization
Common Side Effects
Local Reactions Most people do not have any side effects following
• Injection site pain, redness, swelling, warmth. influenza immunization.
• Temporary limited movement of immunized limb due
Reactions that do occur are usually mild to moderate
to discomfort.
and may last for 1-4 days.
• Local reactions can be more common in those that
receive Fluzone HD.
This is reaction would be considered within the category of expected
Systemic Reactions
• Headache, fatigue, malaise, myalgia, fever, chills, sweating, arthralgia, irritability, loss of appetitive.
Rare Reactions to Influenza Vaccines
Guillain-Barré Syndrome (GBS)
• Is a form of paralysis.
• Is usually temporary.
• Most have full or near complete recovery.
• Associated with 1976 “swine flu” vaccine but no such association with any other influenza vaccine has
been found.
• Studies suggest that the absolute risk of Guillain-Barré syndrome (GBS) in the period following seasonal
and A(H1N1)pdm09 influenza vaccination is about one excess case per million vaccinations and that the
risk of GBS associated with influenza illness is larger (about 17 cases per million influenza-coded health
care encounters, which are a proxy for influenza illness) than that associated with influenza vaccination¹
• Although the evidence considering influenza vaccination and GBS is inadequate to accept or reject a
causal relation between GBS in adults and seasonal influenza vaccination, avoiding subsequent influenza
vaccination of individuals known to have had GBS without other known etiology within 6 weeks of a
previous influenza vaccination appears prudent at this time.¹
Oculorespiratory Syndrome (ORS) ¹
• Mostly reported during 2000-2001 season - few since then.
• Definition: client experiences the following symptoms within 24 hours of influenza immunization
Bilateral Red Eyes PLUS
o One or More Respiratory Symptoms - cough, hoarseness, difficulty swallowing, difficulty
breathing, chest tightness, wheeze, or soar throat
With or Without Facial Swelling
• Once it has occurred, does not necessarily occur again.
17Influenza Immunization Reference Guide
• If previous ORS did not include lower respiratory tract symptoms → ok to proceed with influenza re-
immunization.
• If previous ORS did include lower respiratory symptoms (i.e., wheezing, chest tightness, or difficulty
breathing), do not re-immunize until expert medical consultation is obtained refer to Medical Health
Officer.
Anaphylaxis
• “.. an exaggerated response to an allergen. It is a potentially life threatening event that requires
vigilance on the part of the healthcare practitioner who needs to recognize the condition quickly and
initiate early treatment” (Linton and Watson, 2010, p. 35).
• Anaphylaxis is rare with an estimated range of occurrence of 1-10 episodes per million doses of vaccine
administered. Though rare it should be anticipated in every vaccine.
• Anaphylaxis is a rare complication of immunization, but it should be anticipated in every vaccinee.
• Pre-vaccination screening is important as it includes screening for a history of anaphylaxis.
• Sudden onset and involves two systems
• Begin within 15 minutes after exposure
• The client may have a general feeling of unwell, apprehension, sweating, weakness, agitation.
Fullness in throat
Anaphylaxis management kits should be readily available wherever vaccines are administered and
anticipate a possible anaphylaxis reaction each time they immunize.
• BE PREPARED: Have a plan for the initiation of anaphylaxis.
18Influenza Immunization Reference Guide
Section Six - Reporting Adverse Events Following Immunization (AEFI)
• As per Saskatchewan legislation all adverse events following immunization that are unusual or
unexpected and meet the reporting criteria are reportable by law.
• The definition of an adverse event following immunization is any untoward medical occurrence which
follows immunization and which does not necessarily have a causal relationship with the usage of a
vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding,
symptom or disease.
• All AEFIs should be reported as close to the event as possible. When providing immunization services,
remind the individual or parent to contact you as soon as possible if a serious reaction occurs.
• All immunization providers of publicly funded vaccines submit their AEFI reports via fax to the regional
Medical Health Officer (Public Health)
• The Public Health Agency of Canada’s AEFI reporting form and user guide can be found at:
https://www.canada.ca/en/public-health/services/immunization/reporting-adverse-events-following-
immunization.html
See the
Saskatchewan
Immunization
Manual Chapter 11.
19Influenza Immunization Reference Guide
References
1. National Advisory Committee on Immunization (NACI) Statement on Seasonal Influenza Vaccine for 2020-
2021 https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/canadian-
immunization-guide-statement-seasonal-influenza-vaccine-2020-2021.html
2. Public Health Agency of Canada (2020, July 31). Flu for Health Professionals.
https://www.canada.ca/en/public-health/services/diseases/flu-influenza/health-professionals.html#a2
3. Pinkbook. (2019, April 15). Retrieved August 30, 2020, from
https://www.cdc.gov/vaccines/pubs/pinkbook/index.html
4. Saskatchewan Ministry of Health. (2020) Saskatchewan Influenza Immunization Policy 2020 – 2021.
5. National Advisory Committee on Immunization (NACI) Thimerosal: Updated Statement, July 2007 Volume
3 https://www.canada.ca/content/dam/phac-aspc/migration/phac-aspc/publicat/ccdr-rmtc/07pdf/acs33-
06.pdf
6. National Advisory Committee on Immunization (NACI) Statement on Seasonal Influenza Vaccine for 2019 -
2020 https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/canadian-
immunization-guide-statement-seasonal-influenza-vaccine-2019-2020.html.
7. Saskatchewan Immunization Manual. https://www.ehealthsask.ca/services/Manuals/Pages/SIM.aspx
8. Public Health Agency of Canada. Canadian Immunization Guide. (Evergreen Ed.)Ottawa, On: Available at:
http://www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php
9. Simons,F.E.R, Ardusso, R.F., Bilo, M.B., El-Gamal, Y.M., Ledford, D.K., Ring, J., Brown, S.G., Park, H.,
Sheikh, A., (2011). World Allergy Organization guidelines for the assessment and management of
anaphylaxis. World Allergy Organization Journal, Feb; 4(2), 13–37.
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