| Literature DB >> 36006864 |
Lisa A Grohskopf, Lenee H Blanton, Jill M Ferdinands, Jessie R Chung, Karen R Broder, H Keipp Talbot, Rebecca L Morgan, Alicia M Fry.
Abstract
THIS REPORT UPDATES THE 2021-22 RECOMMENDATIONS OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) CONCERNING THE USE OF SEASONAL INFLUENZA VACCINES IN THE UNITED STATES: (MMWR Recomm Rep 2021;70[No. RR-5]:1-24). Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. For each recipient, a licensed and age-appropriate vaccine should be used. With the exception of vaccination for adults aged ≥65 years, ACIP makes no preferential recommendation for a specific vaccine when more than one licensed, recommended, and age-appropriate vaccine is available. All seasonal influenza vaccines expected to be available in the United States for the 2022-23 season are quadrivalent, containing hemagglutinin (HA) derived from one influenza A(H1N1)pdm09 virus, one influenza A(H3N2) virus, one influenza B/Victoria lineage virus, and one influenza B/Yamagata lineage virus. Inactivated influenza vaccines (IIV4s), recombinant influenza vaccine (RIV4), and live attenuated influenza vaccine (LAIV4) are expected to be available. Trivalent influenza vaccines are no longer available, but data that involve these vaccines are included for reference. INFLUENZA VACCINES MIGHT BE AVAILABLE AS EARLY AS JULY OR AUGUST, BUT FOR MOST PERSONS WHO NEED ONLY 1 DOSE OF INFLUENZA VACCINE FOR THE SEASON, VACCINATION SHOULD IDEALLY BE OFFERED DURING SEPTEMBER OR OCTOBER. HOWEVER, VACCINATION SHOULD CONTINUE AFTER OCTOBER AND THROUGHOUT THE SEASON AS LONG AS INFLUENZA VIRUSES ARE CIRCULATING AND UNEXPIRED VACCINE IS AVAILABLE. FOR MOST ADULTS (PARTICULARLY ADULTS AGED ≥65 YEARS) AND FOR PREGNANT PERSONS IN THE FIRST OR SECOND TRIMESTER, VACCINATION DURING JULY AND AUGUST SHOULD BE AVOIDED UNLESS THERE IS CONCERN THAT VACCINATION LATER IN THE SEASON MIGHT NOT BE POSSIBLE. CERTAIN CHILDREN AGED 6 MONTHS THROUGH 8 YEARS NEED 2 DOSES; THESE CHILDREN SHOULD RECEIVE THE FIRST DOSE AS SOON AS POSSIBLE AFTER VACCINE IS AVAILABLE, INCLUDING DURING JULY AND AUGUST. VACCINATION DURING JULY AND AUGUST CAN BE CONSIDERED FOR CHILDREN OF ANY AGE WHO NEED ONLY 1 DOSE FOR THE SEASON AND FOR PREGNANT PERSONS WHO ARE IN THE THIRD TRIMESTER IF VACCINE IS AVAILABLE DURING THOSE MONTHS: UPDATES DESCRIBED IN THIS REPORT REFLECT DISCUSSIONS DURING PUBLIC MEETINGS OF ACIP THAT WERE HELD ON OCTOBER 20, 2021; JANUARY 12, 2022; FEBRUARY 23, 2022; AND JUNE 22, 2022. PRIMARY UPDATES TO THIS REPORT INCLUDE THE FOLLOWING THREE TOPICS: 1) THE COMPOSITION OF 2022-23 U.S. SEASONAL INFLUENZA VACCINES; 2) UPDATES TO THE DESCRIPTION OF INFLUENZA VACCINES EXPECTED TO BE AVAILABLE FOR THE 2022-23 SEASON, INCLUDING ONE INFLUENZA VACCINE LABELING CHANGE THAT OCCURRED AFTER THE PUBLICATION OF THE 2021-22 ACIP INFLUENZA RECOMMENDATIONS; AND 3) UPDATES TO THE RECOMMENDATIONS CONCERNING VACCINATION OF ADULTS AGED ≥65 YEARS. FIRST, THE COMPOSITION OF 2022-23 U.S. INFLUENZA VACCINES INCLUDES UPDATES TO THE INFLUENZA A(H3N2) AND INFLUENZA B/VICTORIA LINEAGE COMPONENTS. U.S.-LICENSED INFLUENZA VACCINES WILL CONTAIN HA DERIVED FROM AN INFLUENZA A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE VIRUS (FOR EGG-BASED VACCINES) OR AN INFLUENZA A/WISCONSIN/588/2019 (H1N1)PDM09-LIKE VIRUS (FOR CELL CULTURE-BASED OR RECOMBINANT VACCINES); AN INFLUENZA A/DARWIN/9/2021 (H3N2)-LIKE VIRUS (FOR EGG-BASED VACCINES) OR AN INFLUENZA A/DARWIN/6/2021 (H3N2)-LIKE VIRUS (FOR CELL CULTURE-BASED OR RECOMBINANT VACCINES); AN INFLUENZA B/AUSTRIA/1359417/2021 (VICTORIA LINEAGE)-LIKE VIRUS; AND AN INFLUENZA B/PHUKET/3073/2013 (YAMAGATA LINEAGE)-LIKE VIRUS. SECOND, THE APPROVED AGE INDICATION FOR THE CELL CULTURE-BASED INACTIVATED INFLUENZA VACCINE, FLUCELVAX QUADRIVALENT (CCIIV4), WAS CHANGED IN OCTOBER 2021 FROM ≥2 YEARS TO ≥6 MONTHS. THIRD, RECOMMENDATIONS FOR VACCINATION OF ADULTS AGED ≥65 YEARS HAVE BEEN MODIFIED. ACIP RECOMMENDS THAT ADULTS AGED ≥65 YEARS PREFERENTIALLY RECEIVE ANY ONE OF THE FOLLOWING HIGHER DOSE OR ADJUVANTED INFLUENZA VACCINES: QUADRIVALENT HIGH-DOSE INACTIVATED INFLUENZA VACCINE (HD-IIV4), QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (RIV4), OR QUADRIVALENT ADJUVANTED INACTIVATED INFLUENZA VACCINE (AIIV4). IF NONE OF THESE THREE VACCINES IS AVAILABLE AT AN OPPORTUNITY FOR VACCINE ADMINISTRATION, THEN ANY OTHER AGE-APPROPRIATE INFLUENZA VACCINE SHOULD BE USED: THIS REPORT FOCUSES ON RECOMMENDATIONS FOR THE USE OF VACCINES FOR THE PREVENTION AND CONTROL OF SEASONAL INFLUENZA DURING THE 2022-23 INFLUENZA SEASON IN THE UNITED STATES. A BRIEF SUMMARY OF THE RECOMMENDATIONS AND A LINK TO THE MOST RECENT BACKGROUND DOCUMENT CONTAINING ADDITIONAL INFORMATION ARE AVAILABLE AT: https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu.html. These recommendations apply to U.S.-licensed influenza vaccines used according to Food and Drug Administration-licensed indications. Updates and other information are available from CDC's influenza website (https://www.cdc.gov/flu). Vaccination and health care providers should check this site periodically for additional information.Entities:
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Year: 2022 PMID: 36006864 PMCID: PMC9429824 DOI: 10.15585/mmwr.rr7101a1
Source DB: PubMed Journal: MMWR Recomm Rep ISSN: 1057-5987
Influenza vaccines — United States, 2022–23 influenza season*
| Trade name (manufacturer) | Presentations | Age indication | Route | Mercury (from thimerosal, if present), | |
|---|---|---|---|---|---|
|
| |||||
| Afluria Quadrivalent
(Seqirus) | 0.5-mL PFS§ | ≥3 yrs§ | 15 | IM¶ | —** |
| 5.0-mL MDV§ | ≥6 mos§ (needle and syringe)
18 through 64 yrs (jet injector) | 7.5 | IM¶ | 24.5 | |
| Fluarix Quadrivalent
(GlaxoSmithKline) | 0.5-mL PFS | ≥6 mos | 15 | IM¶ | — |
| FluLaval Quadrivalent
(GlaxoSmithKline) | 0.5-mL PFS | ≥6 mos | 15 | IM¶ | — |
| Fluzone Quadrivalent
(Sanofi Pasteur) | 0.5-mL PFS†† | ≥6 mos†† | 15 | IM¶ | — |
| 0.5-mL SDV†† | ≥6 mos†† | 15 | IM¶ | — | |
| 5.0-mL MDV†† | ≥6 mos†† | 7.5 | IM¶ | 25 | |
|
| |||||
| Flucelvax Quadrivalent
(Seqirus) | 0.5-mL PFS | ≥6 mos | 15 | IM¶ | — |
| 5.0-mL MDV | ≥6 mos | 15 | IM¶ | 25 | |
|
| |||||
| Fluzone High-Dose Quadrivalent
(Sanofi Pasteur) | 0.7-mL PFS | ≥65 yrs | 60 | IM¶ | — |
|
| |||||
| Fluad Quadrivalent
(Seqirus) | 0.5-mL PFS | ≥65 yrs | 15 | IM¶ | — |
|
| |||||
| Flublok Quadrivalent
(Sanofi Pasteur) | 0.5-mL PFS | ≥18 yrs | 45 | IM¶ | — |
|
| |||||
| FluMist Quadrivalent (AstraZeneca) | 0.2-mL prefilled single-use intranasal sprayer | 2 through 49 yrs | 106.5–7.5 fluorescent focus units/0.2 mL | NAS | — |
Abbreviations: ACIP = Advisory Committee on Immunization Practices; FDA = Food and Drug Administration; HA = hemagglutinin; IIV4 = inactivated influenza vaccine, quadrivalent; IM = intramuscular; LAIV4 = live attenuated influenza vaccine, quadrivalent; MDV = multidose vial; NAS = intranasal; PFS = prefilled syringe; RIV4 = recombinant influenza vaccine, quadrivalent; SDV = single-dose vial.
* Vaccination providers should consult FDA-approved prescribing information for 2022–23 influenza vaccines for the most complete and updated information, including but not limited to indications, contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccines are available at https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states. Availability and characteristics of specific products and presentations might change or differ from what is described in this table and in the text of this report.
† Although a history of severe allergic reaction (e.g., anaphylaxis) to egg is a labeled contraindication to the use of egg-based IIV4s and LAIV4, ACIP recommends that persons with a history of egg allergy may receive any licensed, recommended influenza vaccine that is otherwise appropriate for their age and health status. Those who report having had reactions to egg involving symptoms other than urticaria (e.g., angioedema or swelling, respiratory distress, lightheadedness, or recurrent emesis) or who required epinephrine or another emergency medical intervention should be vaccinated in an inpatient or outpatient medical setting (including but not necessarily limited to hospitals, clinics, health departments, and physician offices) supervised by a health care provider who is able to recognize and manage severe allergic reactions, if a vaccine other than ccIIV4 or RIV4 is used.
§ The approved dose volume for Afluria Quadrivalent is 0.25 mL for children aged 6 through 35 months and 0.5 mL for persons aged ≥3 years. However, 0.25-mL prefilled syringes are not expected to be available for the 2022–23 season. For children aged 6 through 35 months, a 0.25-mL dose must be obtained from a multidose vial.
¶ IM-administered influenza vaccines should be given by needle and syringe only, with the exception of the MDV presentation of Afluria Quadrivalent, which may alternatively be given by the PharmaJet Stratis jet injector for persons aged 18 through 64 years only. For adults and older children, the recommended site for intramuscular influenza vaccination is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Additional specific guidance regarding site selection and needle length for intramuscular administration is available in the ACIP General Best Practice Guidelines for Immunization, available at https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html.
** Not applicable.
†† Fluzone Quadrivalent is currently approved for ages 6 through 35 months at either 0.25 mL or 0.5 mL per dose; however, 0.25-mL prefilled syringes are not expected to be available for the 2022–23 influenza season. If a prefilled syringe of Fluzone Quadrivalent is used for a child in this age group, the dose volume will be 0.5 mL per dose.
Contraindications and precautions for the use of influenza vaccines — United States, 2022–23 influenza season*
| Vaccine type | Contraindications | Precautions |
|---|---|---|
| Egg-based IIV4s | • History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine† or to a previous dose of any influenza vaccine (i.e., any egg-based IIV, ccIIV, RIV, or LAIV)§ | • Moderate or severe acute illness with or without fever |
| ccIIV4 | • History of severe allergic reaction (e.g., anaphylaxis) to a previous dose of any ccIIV or any component of ccIIV4§ | • Moderate or severe acute illness with or without fever |
| RIV4 | • History of severe allergic reaction (e.g., anaphylaxis) to a previous dose of any RIV or any component of RIV4§ | • Moderate or severe acute illness with or without fever |
| LAIV4 | • History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine† or to a previous dose of any influenza vaccine (i.e., any egg-based IIV, ccIIV, RIV, or LAIV)§ | • Moderate or severe acute illness with or without fever |
Abbreviations: ACIP = Advisory Committee on Immunization Practices; ccIIV = cell culture–based inactivated influenza vaccine (any valency); ccIIV4 = cell culture–based inactivated influenza vaccine, quadrivalent; CSF = cerebrospinal fluid; FDA = Food and Drug Administration; IIV = inactivated influenza vaccine (any valency); IIV4 = inactivated influenza vaccine, quadrivalent; LAIV = live attenuated influenza vaccine (any valency); LAIV4 = live attenuated influenza vaccine, quadrivalent; RIV = recombinant influenza vaccine (any valency); RIV4 = recombinant influenza vaccine, quadrivalent.
* When a contraindication is present, a vaccine should not be administered. When a precaution is present, vaccination should generally be deferred but might be indicated if the benefit of protection from the vaccine outweighs the risk for an adverse reaction (see ACIP General Best Practice Guidelines for Immunization, available at https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html). Vaccination providers should check FDA-approved prescribing information for 2022–23 influenza vaccines for the most complete and updated information, including (but not limited to) indications, contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccines are available at https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states.
† Although a history of severe allergic reaction (e.g., anaphylaxis) to egg is a labeled contraindication to the use of egg-based IIV4s and LAIV4, ACIP recommends that persons with a history of egg allergy may receive any licensed, recommended influenza vaccine that is otherwise appropriate for their age and health status. Those who report having had reactions to egg involving symptoms other than urticaria (e.g., angioedema or swelling, respiratory distress, lightheadedness, or recurrent emesis) or who required epinephrine or another emergency medical intervention should be vaccinated in an inpatient or outpatient medical setting, including but not necessarily limited to hospitals, clinics, health departments, and physician offices, if a vaccine other than ccIIV4 or RIV4 is used. Vaccine administration should be supervised by a health care provider who is able to recognize and manage severe allergic reactions.
§ Labeled contraindication noted in package insert.
¶ If administered, vaccination should occur in a medical setting and should be supervised by a health care provider who can recognize and manage severe allergic reactions. Providers can consider consultation with an allergist in such cases, to assist in identification of the component responsible for the allergic reaction.
** Age-appropriate injectable vaccines are recommended for persons with cochlear implant due to the potential for CSF leak, which might exist for a period after implantation. Providers might consider consultation with a specialist concerning risk for persistent CSF leak if an age-appropriate inactivated or recombinant vaccine cannot be used.
†† Use of LAIV4 in context of influenza antivirals has not been studied; however, interference with activity of LAIV4 is biologically plausible, and this possibility is noted in the package insert for LAIV4. In the absence of data supporting an adequate minimum interval between influenza antiviral use and LAIV4 administration, the intervals provided are based on the half-life of each antiviral. The interval between influenza antiviral receipt and LAIV4 for which interference might potentially occur might be further prolonged in the presence of medical conditions that delay medication clearance (e.g., renal insufficiency). Influenza antivirals might also interfere with LAIV4 if initiated within 2 weeks after vaccination. Persons who receive antivirals during the period starting with the specified time before receipt of LAIV4 through 2 weeks after receipt of LAIV4 should be revaccinated with an age-appropriate IIV or RIV4.
Influenza vaccine contraindications and precautions for persons with a history of severe allergic reaction to a previous dose of an influenza vaccine* — United States, 2022–23 influenza season
| Vaccine (of any valency) associated with previous severe allergic reaction | Available 2022–23 influenza vaccines | ||
|---|---|---|---|
| Egg-based IIV4s and LAIV4 | ccIIV4 | RIV4 | |
| Any egg-based IIV or LAIV | Contraindication† | Precaution§ | Precaution§ |
| Any ccIIV | Contraindication† | Contraindication† | Precaution§ |
| Any RIV | Contraindication† | Precaution§ | Contraindication† |
| Unknown influenza vaccine | Allergist consultation recommended | ||
Abbreviations: ACIP = Advisory Committee on Immunization Practices; ccIIV = cell culture–based inactivated influenza vaccine (any valency); ccIIV4 = cell culture–based inactivated influenza vaccine, quadrivalent; FDA = Food and Drug Administration; IIV = inactivated influenza vaccine (any valency); IIV4 = inactivated influenza vaccine, quadrivalent; LAIV = live attenuated influenza vaccine (any valency); LAIV4 = live attenuated influenza vaccine, quadrivalent; RIV = recombinant influenza vaccine (any valency); RIV4 = recombinant influenza vaccine, quadrivalent.
* Vaccination providers should check FDA-approved prescribing information for 2022–23 influenza vaccines for the most complete and updated information, including (but not limited to) indications, contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccines are available at https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states.
† When a contraindication is present, a vaccine should not be administered, consistent with ACIP General Best Practice Guidelines for Immunization (Kroger A, Bahta L, Hunter P. General best practice guidelines for immunization: best practices guidance of the Advisory Committee on Immunization Practices [ACIP]. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html). In addition to the contraindications based on history of severe allergic reaction to influenza vaccines that are noted in the table, each individual influenza vaccine is contraindicated for persons who have had a severe allergic reaction (e.g., anaphylaxis) to any component of that vaccine. Vaccine components can be found in package inserts. Although a history of severe allergic reaction (e.g., anaphylaxis) to egg is a labeled contraindication to the use of egg-based IIV4s and LAIV4, ACIP recommends that persons with a history of egg allergy may receive any licensed, recommended influenza vaccine that is otherwise appropriate for their age and health status. Those who report having had reactions to egg involving symptoms other than urticaria (e.g., angioedema or swelling, respiratory distress, lightheadedness, or recurrent emesis) or who required epinephrine or another emergency medical intervention should be vaccinated in an inpatient or outpatient medical setting (including but not necessarily limited to hospitals, clinics, health departments, and physician offices), if a vaccine other than ccIIV4 or RIV4 is used. Vaccine administration should be supervised by a health care provider who is able to recognize and manage severe allergic reactions.
§ When a precaution is present, vaccination should generally be deferred but might be indicated if the benefit of protection from the vaccine outweighs the risk for an adverse reaction, consistent with ACIP General Best Practice Guidelines for Immunization (Kroger A, Bahta L, Hunter P. General best practice guidelines for immunization: best practices guidance of the Advisory Committee on Immunization Practices [ACIP]. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html). Providers can consider using the following vaccines in these instances; however, vaccination should occur in an inpatient or outpatient medical setting with supervision by a health care provider who is able to recognize and manage severe allergic reactions: 1) for persons with a history of severe allergic reaction (e.g., anaphylaxis) to any egg-based IIV or LAIV of any valency, the provider can consider administering ccIIV4 or RIV4; 2) for persons with a history of severe allergic reaction (e.g., anaphylaxis) to any ccIIV of any valency, the provider can consider administering RIV4; and 3) for persons with a history of severe allergic reaction (e.g., anaphylaxis) to any RIV of any valency, the provider can consider administering ccIIV4. Providers can also consider consulting with an allergist to help determine which vaccine component is responsible for the allergic reaction.
FIGUREInfluenza vaccine dosing algorithm for children aged 6 months through 8 years* — Advisory Committee on Immunization Practices, United States, 2022–23 influenza season
* Children aged 6 months through 8 years who require 2 doses of influenza vaccine should receive their first dose as soon as possible (including during July and August, if vaccine is available) to allow the second dose (which must be administered ≥4 weeks later) to be received, ideally, by the end of October. For children aged 8 years who require 2 doses of vaccine, both doses should be administered even if the child turns age 9 years between receipt of dose 1 and dose 2.
Dose volumes for inactivated influenza vaccines approved for children aged 6 through 35 months* — United States, 2022–23 influenza season
| Trade name (Manufacturer) | Dose volume for children aged 6 through 35 mos
( |
|---|---|
| Afluria Quadrivalent (Seqirus) | 0.25 mL (7.5 |
| Fluarix Quadrivalent (GlaxoSmithKline) | 0.5 mL (15 |
| Flucelvax Quadrivalent (Seqirus) | 0.5 mL (15 |
| FluLaval Quadrivalent (GlaxoSmithKline) | 0.5 mL (15 |
| Fluzone Quadrivalent (Sanofi Pasteur) | 0.5 mL (15 |
Abbreviation: HA = hemagglutinin.
* For persons aged ≥36 months (≥3 years), the dose volume is 0.5 mL per dose for all inactivated influenza vaccines with the exception of Fluzone High-Dose Quadrivalent (HD-IIV4), which is licensed for persons aged ≥65 years and for which the dose volume is 0.7 mL per dose.
† The approved dose volume for Afluria Quadrivalent is 0.25 mL for children aged 6 through 35 months and 0.5 mL for persons aged ≥3 years. However, 0.25-mL prefilled syringes are not expected to be available for the 2022–23 season. For children aged 6 through 35 months, a 0.25-mL dose must be obtained from a multidose vial.
§ Per the package insert, Fluzone Quadrivalent is currently approved for children aged 6 through 35 months at either 0.25 mL or 0.5 mL per dose; however, 0.25-mL prefilled syringes are no longer available. If a prefilled syringe of Fluzone Quadrivalent is used for a child in this age group, the dose volume will be 0.5 mL per dose. The 0.5-mL single-dose vials should be accessed for only 1 dose and multidose vials for only 10 doses, regardless of the volume of the doses obtained or any remaining volume in the vial. Any vaccine remaining in a vial after the maximum number of doses has been removed should be discarded.