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Influenza vaccine

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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. Fluarix Tetra · GSK
    3. Influvac sub-unit Tetra · Mylan
    4. Quadrivalent Influenza vaccine (Split virion, inactivated) · Sanofi Pasteur
    5. Adjuvanted trivalent influenza vaccine (surface antigen, inactivated) · Seqirus UK Ltd
    6. Flucelvax Tetra Influenza Vaccine (surface antigen, inactivated) · Seqirus
    8. Infanrix hexa · GSK
    9. Flublock Quadrivalent Influenza vaccine · Sanofi Pasteur
    10. Trivalent Influenza vaccine (Split virion, inactivated) High dose · Sanofi Pasteur
  4. Lactation Safety Information
  5. New Medicines
    1. Flucelvax Tetra (EU); Flucelvax Quadrivalent (US) · Influenza prophylaxis, in adults and children aged 9 years and older
    2. Fluad Tetra · Influenza prophylaxis in adults aged 65 years and older
    3. Supemtek · Influenza prophylaxis in adults
    4. Influenza prevention in patients aged 65 years and above
    5. M-001 · Influenza A and B - universal vaccine against current and future strains

dm+d

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Articles

Written Instruction for the administration of seasonal ‘flu vaccination (2021/22 version)

24 November 2020It is anticipated that written instruction templates for Occupational Health vaccination of health and social care staff (2021/22 season) will be available in due course…

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 2020/2021 INFLUENZA SEASON ONLY

In the event of an inadvertent temperature excursion the following data may be used:
Before use, the vaccine may be taken out of the refrigerator once for a maximum period of 12 hours at a temperature not above 25°C. If the vaccine has not been used after this 12 hour period, it should be discarded. AstraZeneca also recommend that if there are deviations from the recommended storage temperatures, healthcare professionals should contact their medical information department directly on an individual basis.

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

See above
Information not provided by the company
12 October 2020
London Medicines Information Service

Fluarix TetraGSK

GSK
Fluarix Tetra
Suspension for injection in pre-filled syringe

THIS ADVICE APPLIES FOR 2020/2021 INFLUENZA SEASON ONLY

Contact GSK in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

Do not freeze. Store in the original package in order to protect from light.

 

28 September 2020
London Medicines Information Service

Influvac sub-unit TetraMylan

Mylan
Influvac sub-unit Tetra
Suspension for injection in pre-filled syringe

THIS ADVICE APPLIES FOR 2020/2021 INFLUENZA SEASON ONLY

Influvac will still be suitable for use if the vaccines have been subjected to the following temperature excursions:
Not less then -4°C to 2°C for 21 days or less or from 8°C and up to 25°C for 24 hours or less.

It must be confirmed that a temperature excursion has occurred only once for Influvac vaccines. Two or more temperature excursions affecting the same vaccines from any batch must be treated as cumulative temperature excursions and not separate.
Where a temperature excursion has occurred beyond the above parameters, it should be escalated to Mylan Medical Information to make a decision as to whether the vaccine(s) is/are suitable/not suitable for use.
The batch number and expiry date of the vaccine(s) concerned will be required in order for Mylan Medicines Information to process each temperature excursion.

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

No if exposed to conditions as described above
Yes if exposed to conditions as described above
14 October 2020
London MI service

Quadrivalent Influenza vaccine (Split virion, inactivated)Sanofi Pasteur

Sanofi Pasteur
Quadrivalent Influenza vaccine (Split virion, inactivated)
suspension for injection in 0.5ml prefilled syringe

THIS ADVICE APPLIES FOR 2020/2021 INFLUENZA SEASON ONLY

Contact Sanofi Pasteur in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

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

 

12 October 2020
London MI Service

Adjuvanted trivalent influenza vaccine (surface antigen, inactivated)Seqirus UK Ltd

Seqirus UK Ltd
Adjuvanted trivalent influenza vaccine (surface antigen, inactivated)
Suspension for injection in pre-filled syringe

THIS ADVICE APPLIES FOR 2020/2021 INFLUENZA SEASON ONLY

Contact Seqirus UK Ltd in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

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

Storage at ambient temperature:  Information not provided by the manufacturer.

Comments Do not freeze. Keep the syringe in the outer carton in order to protect from light.

12 October 2020
London Medicines Information Service

Flucelvax Tetra Influenza Vaccine (surface antigen, inactivated)Seqirus

Seqirus
Flucelvax Tetra Influenza Vaccine (surface antigen, inactivated)
Suspension for injection in pre-filled syringe

THIS ADVICE APPLIES FOR 2020/2021 INFLUENZA SEASON ONLY

Contact Seqirus UK Ltd in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

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

 

Do not freeze. Keep the syringe in the outer carton in order to protect from light.

12 October 2020
London MI Service

Infanrix hexaGSK

GSK
Infanrix hexa
Powder and suspension for suspension for injection

In the event of an inadvertent temperature excursion the following data may be used:
A maximum cumulative time of 72 hours is permitted for the vaccine to be at temperatures above 8°C through 25°C . If these conditions are met, the expiration date on the vaccine’s label or packaging still applies.
If these conditions are not met, the vaccine should be discarded.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
Contact GSK in cases where the product has been exposed to temperature deviation other than described above. Refer to the current BNF for company contact details.

See above
Information not provided by manufacturer.

Do not Freeze

29 July 2020
London MI Service

Flublock Quadrivalent Influenza vaccine Sanofi Pasteur

Sanofi Pasteur
Flublock Quadrivalent Influenza vaccine
Solution for injection in 0.5ml pre-filled syringe

THIS ADVICE APPLIES FOR 2020/2021 INFLUENZA SEASON ONLY

Contact Sanofi Pasteur in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Storage at ambient temperature:
Information not provided by manufacturer

Do not freeze. Discard if the product has been frozen. Protect syringes from light.

11 November 2020
London Medicines Information Service

Trivalent Influenza vaccine (Split virion, inactivated) High doseSanofi Pasteur

Sanofi Pasteur
Trivalent Influenza vaccine (Split virion, inactivated) High dose
suspension for injection in pre-filled syringe

THIS ADVICE APPLIES FOR 2020/2021 INFLUENZA SEASON ONLY

Contact Sanofi Pasteur in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Storage at ambient temperature:
Information not provided by manufacturer

12 October 2020
London Medicines Information 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

Flucelvax Tetra (EU); Flucelvax Quadrivalent (US) Influenza prophylaxis, in adults and children aged 9 years and older

Information

Flucelvax Tetra (EU); Flucelvax Quadrivalent (US)
Vaccine
Seqirus
Seqirus

Development and Regulatory status

Launched
Launched
Launched
August 2019
Nov 20Licence extension approved for use in children from 9 years of age to include use in children from 2 years of age [6].
Sep 20EU positive opinion to extend the licence from use in children from 9 years of age to include use in children from 2 years of age [5].
Aug 19Available in the UK. 15 microgram of each per 0.5ml. Price: susp in pre-filled syringe, 1=£9.94; 10=£99.40 [4].
Dec 18Approved in the EU for prophylaxis of influenza in adults and children from 9 years of age, for use in accordance with official recommendations [2].
Oct 18Positive opinion from the CHMP in the EU. Launch anticipated for the 2018/19 flu season [1].
May 16Approved in the US [1].

Category

A quadrivalent surface antigen, inactivated, influenza vaccine, prepared in MDCK cell cultures [2]
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 [2].
Influenza prophylaxis, in adults and children aged 9 years and older
Intramuscular

Trial or other data

Dec 18EU approval based on two PIII trials: NCT01992094 (Study V130-01) in adults (n=2680) and NCT01992107 (Study V130-03) in children (n=2333) [2,3].

Evidence based evaluations

EPAR

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 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

Approved (Licensed)
Approved (Licensed)
Launched
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

Influenza prevention in patients aged 65 years and above

Information

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].