Zoonotic Influenza Vaccine Seqirus
Authorised
This medicine is authorised for use in the European Union
Zoonotic influenza vaccine (H5N8) (surface antigen, inactivated, adjuvanted)
MedicineHumanAuthorised
Overview
Zoonotic influenza vaccine Seqirus is a vaccine used in adults to protect against flu caused by H5 strains of the influenza A virus (also known as avian influenza or bird flu). Bird flu is a zoonotic infection (an infection that can spread from animals to humans).
Zoonotic influenza vaccine Seqirus contains .
Zoonotic influenza vaccine Seqirus contains a flu strain called A/Astrakhan/3212/2020 (H5N8)-like strain (CBER-RG8A) (clade 2.3.4.4b) and is based on parts of influenza virus that have been inactivated (killed) so that they do not cause disease.
The vaccine is given as two doses, injected into the muscles of the upper arm, three weeks apart.
Zoonotic influenza vaccine Seqirus can only be obtained with a prescription and should be used according to official recommendations issued at national level by public health bodies.
For more information about using Zoonotic influenza vaccine Seqirus, see the package leaflet or contact your doctor or pharmacist.
Vaccines work by preparing the immune system (the body’s natural defences) to defend itself against a specific viral disease. This vaccine contains some parts of the H5N8 virus that has first been inactivated (killed) so that it does not cause any disease. When a person is given the vaccine, the immune system recognises parts of the virus in the vaccine as ‘foreign’ and makes antibodies against them. If, later, the vaccinated person comes into contact with the virus, these antibodies, together with other components of the immune system, will be able to kill the virus and help protect against the disease.
Zoonotic influenza vaccine Seqirus contains an adjuvant, a substance that helps strengthen the immune response to the vaccine.
Zoonotic influenza vaccine Seqirus has been shown to produce sufficient antibodies to stimulate an immune response and protect against H5N1.
Two main studies using a strain called A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14) provided data on vaccination with Zoonotic influenza vaccine Seqirus in healthy adults aged below and above 60 years. In one study involving 3,372 people, subjects were given either a seasonal flu vaccine followed by two doses of Zoonotic influenza vaccine Seqirus three weeks apart, or placebo (a dummy vaccine) followed by two doses of an adjuvanted seasonal vaccine three weeks apart. In the first study, 21 days after the second injection, around 90% of people aged below 60 years and around 80% of those aged above 60 years had levels of antibodies that would protect them against H5N1.
In the second study involving 240 people, subjects were given Zoonotic influenza vaccine Seqirus using different vaccination schedules. The studies looked at the ability of the vaccine to trigger the production of antibodies (‘immunogenicity’) against the flu virus. This study established that Zoonotic influenza vaccine Seqirus should be given as two doses at least three weeks apart.
A third study, using a vaccine with strain A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23), was carried out in 343 adults aged below and above 60 years. The study showed that 21 days after the second injection, around 70% of adults below 60 years and around 64% of adults above 60 years achieved an acceptable antibody response.
For the full list of side effects and restrictions with Zoonotic influenza vaccine Seqirus, see the package leaflet.
The most common side effects with Zoonotic influenza vaccine Seqirus (which may affect more than 1 patient in 10) include headache, myalgia (muscle pain), reactions at the site of injection (swelling, pain, redness and hardening of the skin), tiredness, chills and feeling generally unwell.
Zoonotic influenza vaccine Seqirus should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, including those found at trace (very low) levels (egg or chicken protein, ovalbumin [a protein in egg white], kanamycin or neomycin sulphate [antibiotics], formaldehyde, hydrocortisone and cetyltrimethylammonium bromide).
Zoonotic influenza vaccine Seqirus was shown to produce sufficient antibodies to stimulate an immune response and protect against H5N1. An updated version of the vaccine containing fragments from inactivated H5N8 was considered to be the best candidate to provide protection against other H5 strains.
The European Medicines Agency therefore decided that Zoonotic influenza vaccine Seqirus’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zoonotic influenza vaccine Seqirus have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Zoonotic influenza vaccine Seqirus are continuously monitored. Suspected side effects reported with Zoonotic influenza vaccine Seqirus are carefully evaluated and any necessary action taken to protect patients.
Zoonotic influenza vaccine Seqirus received a marketing authorisation valid throughout the EU on 9 October 2023.
Product information
Latest procedure affecting product information: II/0001
09/04/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Zoonotic Influenza Vaccine Seqirus
- Active substance
- A/Astrakhan/3212/2020 (H5N8)-like strain (CBER-RG8A) (clade 2.3.4.4b)
- International non-proprietary name (INN) or common name
- Zoonotic influenza vaccine (H5N8) (surface antigen, inactivated, adjuvanted)
- Therapeutic area (MeSH)
- Influenza A Virus, H5N8 Subtype
- Anatomical therapeutic chemical (ATC) code
- J07BB02
Pharmacotherapeutic group
VaccinesTherapeutic indication
Active immunisation against H5N8 subtype of Influenza A virus.
Zoonotic Influenza Vaccine Seqirus H5N8 is indicated for active immunisation against H5 subtype influenza A viruses in adults 18 years of age and above (see sections 4.4 and 5.1). The use of this vaccine should be in accordance with official recommendations.
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