The first stop for professional medicines advice

Influenza vaccine

Published
Topics: Influenza vaccineNew MedicinesNHS England commissioned new medicines · Safety in BreastfeedingStability outside the fridgeVaccinating ·
Contents
  1. dm+d
  2. Articles
  3. Refrigerated Storage
    1. Fluenz Tetra · AstraZeneca
    2. Influvac sub-unit Tetra · Viatris (Formerly Mylan)
    3. Quadrivalent Influenza vaccine · Sanofi
    4. Cell-based quadrivalent influenza vaccine · Seqirus
    5. Supemtek · Sanofi
    6. Adjuvant quadrivalent influenza vaccine · Seqirus
  4. Lactation Safety Information
  5. New Medicines
    1. Fluad Tetra · Influenza prophylaxis in adults aged 65 years and older
    2. Supemtek · Influenza prophylaxis in adults
    3. NanoFlu · Influenza prevention in patients aged 65 years and above
    4. M-001 · Influenza A and B - universal vaccine against current and future strains
    5. Fluzone High-Dose Quadrivalent · Influenza prevention in people aged 65 years and older

dm+d

46233009

Articles

Small volume intramuscular injections in people taking oral anticoagulants

11 May 2022Advice and a summary of the issues and evidence for healthcare professionals with concerns about use of IM injections in people taking oral anticoagulants

Written Instruction for the administration of seasonal 'flu vaccination

25 August 2021Advice on using written instructions for the administration of 'flu vaccinations to healthcare staff.

Safety in Lactation: Vaccines and antisera

21 September 2020Although vaccines and toxoids (diphtheria and tetanus) are considered to be compatible with breastfeeding, their use should be limited to those situations where there is…

Can small volume intramuscular injections be given to patients taking oral anticoagulants?

17 September 2018This Medicines Q&A discusses the potential risks associated with the administration of small volume IM injections to patients taking oral anticoagulants. It has been partially…
Search Articles

Refrigerated Storage

Fluenz TetraAstraZeneca

AstraZeneca
Fluenz Tetra
Nasal Spray Suspension

THIS ADVICE APPLIES FOR 2022/2023 INFLUENZA SEASON ONLY
In the event of an inadvertent temperature excursion the following data may be used:
The vaccine may be removed from the refrigerator once for a maximum period of 12 hours at a temperature not above 25°C. Stability data indicates the vaccine components are stable for 12 hours when stored at temperatures from 8°C to 25°C. At the end of this period, Fluenz Tetra should be used immediately or discarded.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

UK Health Security Agency has guidance on responding to errors in vaccine storage, handling and administration.

10 August 2022
London MI Service

Influvac sub-unit TetraViatris (Formerly Mylan)

Viatris (Formerly Mylan)
Influvac sub-unit Tetra
Suspension for injection in pre-filled syringe

THIS ADVICE APPLIES FOR 2022/2023 INFLUENZA SEASON ONLY
Contact Viatris in all cases where a deviation from the recommended storage conditions has occurred. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details and product literature.

UK Health Security Agency has guidance on responding to errors in vaccine storage, handling and administration.

10 August 2022
London MI Service

Quadrivalent Influenza vaccineSanofi

Sanofi
Quadrivalent Influenza vaccine
Suspension for injection in pre-filled syringe

THIS ADVICE APPLIES FOR 2022/2023 INFLUENZA SEASON ONLY
Contact Sanofi in all cases where a deviation from the recommended storage conditions has occurred. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details and product literature.

UK Health Security Agency has guidance on responding to errors in vaccine storage, handling and administration.

10 August 2022
London MI Service

Cell-based quadrivalent influenza vaccineSeqirus

Seqirus
Cell-based quadrivalent influenza vaccine
Suspension for injection in pre-filled syringe

THIS ADVICE APPLIES FOR 2022/2023 INFLUENZA SEASON ONLY
Contact Seqirus in all cases where a deviation from the recommended storage conditions has occurred. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details and product literature.

UK Health Security Agency has guidance on responding to errors in vaccine storage, handling and administration.

10 August 2022
London MI Service

SupemtekSanofi

Sanofi
Supemtek
Solution for injection in pre-filled syringe

THIS ADVICE APPLIES FOR 2022/2023 INFLUENZA SEASON ONLY
Contact Sanofi in all cases where a deviation from the recommended storage conditions has occurred. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details and product literature.

UK Health Security Agency has guidance on responding to errors in vaccine storage, handling and administration.

10 August 2022
London MI Service

Adjuvant quadrivalent influenza vaccineSeqirus

Seqirus
Adjuvant quadrivalent influenza vaccine
Suspension for injection in pre-filled syringe

THIS ADVICE APPLIES FOR 2022/2023 INFLUENZA SEASON ONLY
Contact Seqirus in all cases where a deviation from the recommended storage conditions has occurred. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details and product literature.

UK Health Security Agency has guidance on responding to errors in vaccine storage, handling and administration.

10 August 2022
London MI Service

Lactation Safety Information

Yes
Inactivated (intramuscular or intradermal) or live attenuated (intranasal) vaccines
Live (attenuated) virus in the intranasal vaccine has been adapted to cold in order to replicate in the nasal passage. Survival highly unlikely at breast milk temperatures.
Safety in Lactation: Vaccines and antisera
15 October 2018
Bibliography

New Medicines

Fluad TetraInfluenza prophylaxis in adults aged 65 years and older

Information

Fluad Tetra
Vaccine
Seqirus
Seqirus

Development and Regulatory status

Launched
Launched
None
September 2020
Sep 21Fluad Tetra suspension in pre-filled syringe price for 10 PFS = £118.80 [5].
Sep 20Company notes that the timing of approval was such that Fluad Tetra will not be available for use during this 2020/2021 influenza season. However, UK healthcare professionals can pre-order Fluad Tetra from 1st September 2020 for use during the 2021/2022 influenza season [4].
May 20Approved in EU [3].
Mar 20CHMP issues a positive opinion recommending approval of Fluad Tetra for prophylaxis of influenza in the elderly (65 years of age and older) [2].

Category

Contains inactivated influenza virus surface antigens from 4 different influenza virus strains (two A and two B subtypes). Also contains the adjuvant MF59C.1 (MF59), which is designed to increase and broaden the antigen-specific immune response
Worldwide, annual influenza epidemics result in about 90 million cases with approximately 3 to 5 million cases of severe illness, and about 250,000 to 500,000 deaths, of which 28,000 to 111,500 occur in children [1].
Influenza prophylaxis in adults aged 65 years and older
Intramuscular

Evidence based evaluations

EPAR

SupemtekInfluenza prophylaxis in adults

Information

Supemtek
Vaccine
Sanofi
Sanofi

Development and Regulatory status

Launched
Approved (Licensed)
Launched
April 2021
Apr 21Available in the UK. Price = 1x10 single dose pre-filled syringes cost £220.00 [5,6,7].
Nov 20Approved in EU and UK [4].
Sep 20Recommended for EU approval by CHMP - the full indication is "for active immunization for the prevention of influenza disease in adults. It should be used in accordance with official recommendations" [3].

Category

A quadrivalent entirely egg-free recombinant haemagglutinin vaccine produced in insect cells
Seroconversion rate in the UK every year is around 10% to 20%, and up to 15% develop symptomatic influenza; peak time for cases is December to March and average GP consultation rate is 50-300 cases per 100,000 population per week. While most people will recover, influenza is considered to be potentially responsible for excess winter deaths in most years. Current vaccine effectiveness is estimated at about 59% overall in adults [2].
Influenza prophylaxis in adults
Intramuscular

Evidence based evaluations

EPAR
FDA doc

NanoFlu Influenza prevention in patients aged 65 years and above

Information

NanoFlu
Vaccine
Novavax
Novavax

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

Recombinant haemagglutinin nanoparticle-based seasonal influenza vaccine. Contains saponin-based Matrix-M adjuvant which stimulates long lasting antibody and cell-mediated immune responses.[3]
Up to 15% of the population can develop influenza in any year. There is a 10-20% seroconversion rate with or without symptoms. In an average year, there are 50-200 GP consultations for influenza or flu-like illnesses per 100,000 population per week.[1]
Influenza prevention in patients aged 65 years and above
Intramuscular

M-001Influenza A and B - universal vaccine against current and future strains

Information

M-001
Vaccine
BiondVax Pharmaceuticals
BiondVax Pharmaceuticals

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Jan 21 Company 2020 annual report indicates that following negative PIII trial results, development of M-001 has been discontinued. The company "is now pursuing opportunities in the infectious disease space, including exploring several alternatives for development of a pipeline of assets". [5]

Category

M-001 induces cellular (CMI) and enhances humoral (priming effect) immune response to a broad range of influenza strains
Up to 15% of the population can develop influenza in any year. There is a 10-20% seroconversion rate with or without symptoms. In an average year, there are 50-200 GP consultations for influenza or flu-like illnesses per 100,000 population per week.[1]
Influenza A and B - universal vaccine against current and future strains
Parenteral

Trial or other data

Oct 20Topline results from PIII trial failed to meet primary or secondary endpoint. A statistically significant difference between vaccinated and placebo groups in reduction of flu illness or severity was not seen [4].

Fluzone High-Dose Quadrivalent Influenza prevention in people aged 65 years and older

Information

Fluzone High-Dose Quadrivalent
Vaccine
Sanofi
Sanofi

Development and Regulatory status

None
None
Launched
Feb 22In the US, Sanofi is pressuring CDC experts to support high-dose Fluzone for older adults. At a CDC Advisory Committee on Immunization Practices (ACIP) meeting Sanofi shared years of data showing the Fluzone High-Dose vaccine, which is indicated for people over the age of 65, is more efficacious than a standard influenza vaccine dose. ACIP isn’t expected to vote on new recommendations until the summer [4] .
Nov 19Approved in the US, where Fluzone High-Dose Quadrivalent (Influenza Vaccine) will be available in time for the 2020-2021 flu season [1].

Category

High dose quadrivalent vaccine containing two strains of influenza type A (H1N1 and H3N2) and two strains of influenza type B (Yamagata and Victoria lineage) [1]
Worldwide, annual influenza epidemics result in about 90 million cases with approximately 3 to 5 million cases of severe illness, and about 250,000 to 500,000 deaths, of which 28,000 to 111,500 occur in children.
Influenza prevention in people aged 65 years and older
Intramuscular

Trial or other data

Nov 19FDA approval was based on data from a PIII immunogenicity and safety study (NCT03282240), in which Fluzone High-Dose Quadrivalent achieved the primary endpoint of non-inferior immunogenicity compared to two trivalent formulations of Fluzone High-Dose, each containing one of the two influenza B strains recommended for inclusion in the vaccine for the 2017-2018 influenza season. In a secondary endpoint of the trial, each B strain in Fluzone High-Dose Quadrivalent induced a superior immune response compared to the trivalent formulation not containing the corresponding B strain. Rates of local and systemic reactions that occurred following immunization with Fluzone High-Dose Quadrivalent were similar to those induced by trivalent formulations of Fluzone High-Dose. The most common reactions occurring after administration were injection-site pain (41.3%), myalgia (22.7%), headache (14.4%), and malaise (13.2%). Onset usually occurred within the first 3 days after vaccination, and the majority of reactions were resolved within 3 days of vaccination. Results from the study were published in Vaccine in Sept 2019 [1,3].