OREGON HEALTH AUTHORITY IMMUNIZATION PROGRAM INACTIVATED, AND RECOMBINANT, INFLUENZA VACCINES - Oregon.gov
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OREGON HEALTH AUTHORITY
IMMUNIZATION PROGRAM
INACTIVATED, AND RECOMBINANT, INFLUENZA VACCINES
(IIV, RIV, ccIV, aIIV)
Last Reviewed 19 September 2018
Last Revised 19 September 2018
This order expires 30 June 2019
All influenza vaccines for use in the 2018–2019 influenza season (Northern
Hemisphere winter) contain the following:1
Trivalent:
• For H1N1, an A/Michigan/45/2015-like virus
• For H3N2, an A/Singapore/INFIMH-16-0019/2016-like virus
• For B Victoria, a B/Colorado/06/2017-like virus
Quadrivalent:
• For B Yamagata, a B/Phuket/3073/2013-like virus
Based on recommendations from the Advisory Committee on Immunization
Practices:1
• Routine annual influenza vaccination is recommended for all persons aged
≥6 months who do not have contraindications.
• Children aged 6 months through 8 years who require 2 doses should
receive their first dose as soon as possible after vaccine becomes
available, and the second dose ≥4 weeks later. See figure 1.
• Persons with a history of egg allergy of any severity may receive any
licensed, recommended, and age-appropriate influenza vaccine (IIV, RIV4,
or LAIV4).
• Fluarix Quadrivalent Vaccine (GSK) is licensed for children ≥6 months of
age with a 0.5-mL dose.
• Afluria quadrivalent is licensed for persons ≥5 years of age.
• Fluzone Intradermal (ID) and Fluvirin will not be available for the 2018–
2019 season.
• No preferential recommendation is made for one influenza vaccine productInfluenza IIV P a g e | 2 of 14
over another, including LAIV4, for persons for whom a given licensed,
recommended product is available.
See separate order for LAIV4 (FluMist®).
I. OREGON IMMUNIZATION MODEL STANDING ORDER:
1. Best Practice (but not required for influenza vaccine only): Check the
ALERT Immunization Information System (IIS) to determine whether the
patient needs this vaccine and any other vaccines.
2. Screen client for contraindications.
3. Provide a current Vaccine Information Statement (VIS) and answer any
questions.
4. Record all required data elements in the client’s permanent health record.
5. Verify needle length for IM injection into the vastus lateralis or deltoid
muscle.
6. Avoid injecting in the upper third of the deltoid muscle.
7. Both client and vaccinator must be seated for vaccine administration.
8. Give the dosage of influenza vaccine recommended for the recipient’s
age intramuscularly (IM). See section II.
9. May be given with all ACIP-recommended child and adult vaccinations.
10. Ask client to remain seated on the premises for 15 minutes after
vaccination to decrease the risk of injury should they faint.
_____________________________________________________________
Signature Health Officer or Medical Provider Date
_____________________________________________________________
Signature Health Officer or Medical Provider DateInfluenza IIV P a g e | 3 of 14
II. A. VACCINE SCHEDULE
Inactivated Influenza Vaccine (IIV) and Recombinant Influenza Vaccine (RIV)
Schedule for the 2018–2019 Flu Season 2-10*
Age Group Dose No. of Doses Route
0.25 mL or 0.5
6–35 months 1 or 2* Intramuscular
mL◊
3–8 years 0.5 mL 1 or 2* Intramuscular
≥9 years 0.5 mL 1 Intramuscular
Optional Formulations With Age Restrictions
≥65 years§ 0.5 mL 1 Intramuscular
*
See figure 1 in section II for algorithm on the number of doses recommended.1
◊
Only FluLaval and Fluarix have the 0.5-mL dose for patients ≥6 months of age: 0.5
mL is not a double dose. The 0.5-mL dose is interchangeable with other flu
vaccines that have a 0.25-mL dosage.
§
Fluzone® High Dose9 and Fluad®adjuvanted. 10Influenza IIV P a g e | 4 of 14
II. B. VACCINE SCHEDULE TABLE:
Figure 1. Influenza vaccine dosing algorithm for children aged 6 months through
8 years — Advisory Committee on Immunization Practices, United States,
2018–19 influenza season.1
Has the child received ≥2 total doses of trivalent or quadrivalent influenza
vaccine before July 1, 2018?
The two doses need not have been received during the same season or
consecutive seasons.
No or
Yes
unknown
2 doses of 2018-19
influenza vaccine.
1 dose of 2018-19 Doses should be
influenza vaccine administered ≥4 weeks
apart.
The 2 doses need not have been received during the same season or
consecutive seasons. Receipt of LAIV4 in the past is still expected to have
primed a child’s immune system despite recent evidence for poor
effectiveness.11Influenza IIV P a g e | 5 of 14
III. U.S. LICENSED INACTIVATED INFLUENZA 2018–2019 2–10
Mercury from
Ovalbumin
Product Age thimerosal
Presentation content
Name Indications (µg Hg/0.5
(µg/0.5 mL)
mL)
Fluzone®2
(Sanofi Pasteur) ≥6 months
5.0-mL
25 ≤0.04◊
IIV4
multidose vial
Fluzone®2
(Sanofi Pasteur)
6–35 0.25-mL
None ≤0.04◊
IIV4
months prefilled syringe
0.5-mL single-
dose prefilled None ≤0.04◊
Fluzone®2 syringe
(Sanofi Pasteur) ≥36 months
IIV4 0.5-mL single-
None ≤0.04◊
dose vial
Fluarix®3 0.5-mL single-
(GSK) ≥6 months dose prefilled ≤0.05
None
IIV4 syringe
FluLaval®4 0.5-mL single- ≤0.3
(ID Biomedical dose prefilled None
distributed by ≥6 months syringe
GSK)
5.0-mL ≤0.3
IIV4 ≤25
multidose vialInfluenza IIV P a g e | 6 of 14
III. U.S. LICENSED INACTIVATED INFLUENZA VACINES 2017–2018 2–10
Cont.
Mercury
from Ovalbumin
Product Age
Presentation thimerosal content
Name Indications
(µg Hg/0.5 (µg/0.5 mL)
mL)
0.5-mL single-
®5 dose prefilled NoneInfluenza IIV P a g e | 7 of 14 * Afluria® is the only FDA-approved influenza vaccine for use with the PharmaJet Needle-Free Injector: restricted to delivery in individuals 18–64 years.5, 6 ◊ Information provided by Sanofi Pasteur Medical Affairs (1–800–822–2463 or MIS.Emails@sanofipasteur.com).2 § Flucelvax® is estimated to contain
Influenza IIV P a g e | 8 of 14
C. LAIV is under a separate order for 2018-2019
V. CONTRAINDICATIONS
NOTE – Persons with a history of egg allergy may receive any licensed and
recommended influenza vaccine that is appropriate for their age and health
status. Vaccine administration should be supervised by a health care provider
who is able to identify and manage severe allergic reactions. 1
A severe allergic reaction (requiring epinephrine or emergency medical
attention) to a previous dose of influenza vaccine is a contraindication to
additional doses, regardless of the component suspected of being responsible
for the reaction.1
Vaccine Allergen(s)
Fluzone®2, 9 Egg protein, formaldehyde
FluLaval®4 Egg protein, formaldehyde, polysorbate 80.
Fluarix®3 Egg protein, hydrocortisone, gentamicin sulfate,
polysorbate 80, formaldehyde
Afluria®5, 6 Egg protein, neomycin, polymyxin B and beta-
propiolactone.
Flucelvax®7 Egg protein, Madin-Darby Canine Kidney (MDCK) cell
protein, polysorbate 80, cetyltrimethylammonium bromide
(CTAB) and beta-propiolactone.
Flublok®8 Polysorbate 20 (Tween®20), baculovirus and Spodoptera
frugiperda cell proteins, baculovirus and cellular DNA, and
Triton X–100.
Fluad®10 Egg protein, MF59C.1 adjuvant,* neomycin, kanamycin,
barium, formaldehyde, cetyltrimethylammonium bromideInfluenza IIV P a g e | 9 of 14
(CTAB). The tip caps of prefilled syringes contain
natural rubber latex.
* Mf59C.1 adjuvant: 9.75 mg squalene, 1.175 mg of polysorbate 80, 1.175 mg
sorbitan trioleate, 0.66 mg sodium citrate dehydrate, 0.04 mg citric acid
monohydrate at pH 6.9–7.7
VI. WARNINGS AND PRECAUTIONS 2–10
1. Persons with moderate or severe illnesses with or without fever should
delay immunization until illness has resolved. However, minor illnesses,
e.g., mild upper respiratory infection (URI) or allergic rhinitis, with or
without fever, do not contraindicate use of influenza vaccine.
2. Persons with a history of Guillain-Barré Syndrome (GBS) following
influenza vaccination have a substantially greater likelihood of
subsequently developing GBS than persons without such a history.
Whether influenza vaccination might be causally associated with this
risk for recurrence is not known. Consult with an individual’s health
care provider and consider avoiding a subsequent influenza
vaccination in persons known to have developed GBS within 6 weeks
of a previous influenza vaccination. Experts believe that the benefits of
influenza vaccination justify yearly vaccination for most persons who
have a history of GBS and who are at risk for severe complications
from influenza.
3. Individuals with bleeding disorders are at risk of hematoma following IM
injection.12
VII. OTHER CONSIDERATIONS
1. Adverse Events: Appropriate medical treatment and supervision must be
available to manage possible anaphylactic reactions following
administration. 2–10 Epinephrine hydrochloride solution (1:1,000) and other
appropriate agents and equipment must be available for immediate use in
case of anaphylactic or acute hypersensitivity reaction.
2. Foreign travelers: Influenza occurs throughout the year in the tropics.
Indications for influenza vaccination should be reviewed before travel. AnyInfluenza IIV P a g e | 10 of 14
person traveling to the tropics, with organized tour groups at any time of the
year or to the Southern Hemisphere during April–September, especially
those at high risk for flu complications, who want to reduce the risk for
influenza infection, should be vaccinated at least 2 weeks before
departure.1
3. Lactation: Approved influenza vaccine (except LAIV) is safe for
breastfeeding mothers and their infants. Breastfeeding does not adversely
affect the immune response and is not a contraindication for vaccination. 2–
10
4. Immunocompromised: Persons infected with HIV: Since influenza can
result in serious illness and complications, vaccination is prudent and will
result in protective antibody levels in many recipients. However, the
antibody response to vaccine may be low in persons with advanced HIV-
related illnesses.13
5. Antiviral agents for influenza: consult CDC’s recommendations for
guidance on clinical management of influenza using antiviral agents at
www.cdc.gov/flu/pdf/professionals/antivirals/antiviral-summary-clinician-
updated.pdf.
6. Hematopoietic Stem Cell Transplant (HSCT) recipients: IIV should be
administered beginning at least 6 months after HSCT and annually
thereafter for the life of the patient. A dose of IIV can be given as soon as 4
months after the transplant, but a second dose should be considered in this
situation.13
7. Ocular and Respiratory Symptoms after Vaccination: Oculo-
respiratory syndrome (ORS) was first described during the 2000–2001
influenza season in Canada. The cause of ORS has not been established.
When assessing whether a patient who experienced ocular and respiratory
symptoms should be revaccinated, providers should determine whether
concerning signs and symptoms were IgE-mediated. If unsure, seek advice
from an allergist/immunologist. See www.cdc.gov/vaccines/hcp/acip-
recs/vacc-specific/downloads/ACIP-recs-2017-18-bkgd.pdf.Influenza IIV P a g e | 11 of 14
VIII. INACTIVATED INFLUENZA VACCINE SIDE EFFECTS AND ADVERSE
REACTIONS 2–10
Local reactions: soreness, erythema, induration at
injection site 15%–20 %
Fever, malaise, chills not common
Allergic reactions rare
IX. STORAGE AND HANDLING
All clinics and pharmacies enrolled with the Vaccines for Children (VFC)
Program must immediately report any storage and handling deviations to the
Oregon Immunization Program at 971-673-4VFC (4823).
Vaccine Temp Storage Issues
Fluzone®2,9
Store in original package to protect from light.
®3
Fluarix
Store at Store multidose vial at recommended
Flucelvax®7
2°–8°C conditions.
Flublok®8
Opened multidose vials should be used
Fluad®10
through the expiration date.
Store in original package to protect from light.
Store multidose vial at recommended
FluLaval®4 Store at conditions.
Afluria®5, 6 2°–8°C
Once the stopper of the multi-dose vial has
been pierced the vial must be discarded
within 28 days.Influenza IIV P a g e | 12 of 14
X: ADVERSE EVENTS REPORTING
Public providers are to complete the Vaccine Adverse Events Reporting System
(VAERS) report online at https://vaers.hhs.gov/reportevent.html.
1. Save a copy of the report number for your records.
2. Send copies of the report and VAERS ID number to the Oregon
Immunization Program Vaccine Safety Coordinator via confidential email
at ORVAERS.Reports@state.or.us or fax (971‐673‐0278).
Private providers are to report events directly to VAERS and can read about
options on how to do so at http://vaers.hhs.gov/index.
VAERS Reporting Table*:
https://vaers.hhs.gov/docs/VAERS_Table_of_Reportable_Events_Followin
g_Vaccination.pdf
Event and interval from vaccination
A. Anaphylaxis or anaphylactic shock (7 days)
B. Shoulder injury related to vaccine administration (7 days)
C. Vasovagal syncope (7 days)
D. Guillain-Barré Syndrome (42 days)
E. Any acute complication or sequelae (including death) of above events
(interval - not applicable)
F. Events described in manufacturer’s package insert as contraindications
to additional doses of vaccine (interval - see package insert)
Effective date: March 21, 2017. The Reportable Events Table (RET) reflects
what is reportable by law (42 USC 300aa-25) to the Vaccine Adverse Event
Reporting System (VAERS) including conditions found in the manufacturer
package insert. In addition, healthcare professionals are encouraged to report
any clinically significant or unexpected events (even if not certain the vaccine
caused the event) for any vaccine, whether or not it is listed on the RET.
Electronic copy of this standing order is available at:
http://1.usa.gov/OregonStandingOrders.Influenza IIV P a g e | 13 of 14
REFERENCES
1. Grohskopf LA, Sokolow LZ, Broder KR, Walter EB, Fry AM, Jernigan
DB. Prevention and control of seasonal influenza with vaccines:
recommendations of the Advisory Committee on Immunization
Practices—United States, 2018–19 influenza season. MMWR
2018;67(RR-3):1–20. DOI: http://dx.doi.org/10.15585/mmwr.rr6703a1.
Accessed 31 August 2018.
2. Fluzone® Quadrivalent 2018–2019 package insert. Available at:
www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedprod
ucts/ucm305089.pdf.
3. Fluarix Quadrivalent® 2018–2019 package insert. Available at:
www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedPro
ducts/UCM220624.pdf. Accessed 19 September 2018.
4. FluLaval® Quadrivalent 2018–2019 package insert. Available at:
www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedPro
ducts/UCM404086.pdf. Accessed 31 August 2018.
5. Afluria® 2018–2019 package insert. Available at:
www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedPro
ducts/UCM263239.pdf. Accessed 19 September 2018.
6. Afluria® Quadrivalent. 2018–2019 package insert. Available at:
www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedPro
ducts/UCM518295.pdf. Accessed 19 September 2018.
7. Flucelvax®IIV4 2018–2019 package insert. Available at:
http://labeling.seqirus.com/PI/US/Flucelvax/EN/Flucelax-Prescribing-
Information.pdf. Accessed 31 August 2018.
8. Flublok® RIV4 2018–2019 package insert. Available at:
https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/Appro
vedProducts/UCM619551.pdf. Accessed 19 September 2018.
9. Fluzone® High-dose Trivalent 2018–2019 package insert. Available at:
https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/Appro
vedProducts/UCM619541.pdf. Accessed 19 September 2018.Influenza IIV P a g e | 14 of 14
10. Fluad®IIV3 2018–2019 package insert. Available at:
www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedPro
ducts/UCM474387.pdf. Accessed 31 August 2018.
11. AAP COMMITTEE ON INFECTIOUS DISEASES. Recommendation for
Prevention and Control of Influenza in Children, 2018–2019. Pediatrics.
2018;142(4):e20182367 Available at:
http://pediatrics.aappublications.org/content/early/2018/08/30/peds.2018
-2367 Accessed 20 September 2018.
12. Kroger AT, Duchin J, Vázquez M. General Best Practice Guidelines for
Immunization. Best Practices Guidance of the Advisory Committee on
Immunization Practices (ACIP). 2017. Available at:
www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-
recs.pdf. Accessed 31 August 2018.
13. Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA Clinical practice
guideline for vaccination of the immunocompromised host. Clin Infect Dis
2014; 58:e44–100. Available at:
https://academic.oup.com/cid/article/58/3/e44/336537. Accessed 31
August 2018. OR
https://www.idsociety.org/Templates/Content.aspx?id=32212256011
Accessed 30 August 2018.You can also read
