The French laboratory Sanofi is marketing for the first time in France a vaccine against influenza called Efluelda, intended for the elderly particularly at risk of the disease. Who is it suitable for? What is its composition? Its side effects? His price ? What we know to date.
Fireworks is the new vaccine developed by the Sanofi-Pasteur laboratory, indicated in flu prevention. It is said to be “overdosed” because it contains 4 times more antigens – substances which generate antibodies in the body – than other influenza vaccines administered in France. It would be particularly effective in people over 60 according to the laboratory and 65 years according to an opinion from the Haute Autorité de Santé (HAS), a category of the population particularly at risk of influenza, because of the fatal complications that the disease can cause. Where and from when can it be administered? What is its composition? Its mode of administration? Its side effects or its contraindications? Info to date.
Definition: what is the Efluelda vaccine?
Efluelda is an influenza vaccine developed by the French laboratory Sanofi-Pasteur, authorized in September 2020 by the European Medicines Agency (EMA) and made available in France as part of the 2021-2022 influenza vaccination campaign, who starts October 26, 2021. It is therefore available this fall, in addition to Vaxigrip Tetra from Sanofi and Influvac Tetra from Mylan. This vaccine is presented as a solution for injection (colorless liquid) in a pre-filled syringe, stored at 2 to 8 ° C for 12 months. It is not subject to a medical prescription. However, it is fully reimbursed only for certain populations or partially on prescription.
What is its composition?
He has 4 times more antigens per strain than standard influenza vaccines.
Efluelda is a flu vaccine quadrivalent said inactivated“, according to Sanofi. An inactivated vaccine does not contain live infectious agents, but wall or toxin fragments from 4 strains of the influenza virus : strain A H1N1, strain A H3N2, strain B Washington and strain B Phuket. It is said to be “in high dose” because it contains 60 µg d’hémagglutinine (HA) for each of the 4 viral strains, against 15 µg for the other influenza vaccines usually administered in France. In other words, he owns 4 times more antigens by strain. This dosage is already used in the United States and Canada, but this is the first time that it is administered in Europe.
What are its indications?
No data are available in other populations such as immunocompromised subjects, or adults under 65 years of age.
Efluelda is indicated for the elderly 60 years old and more in prevention of influenza at a dosage ofa dose of 0.7 ml, indicates the Sanofi laboratory (other vaccines contain 0.5 ml of product). People over 60 have an “weakened by age” immune system, which needs to be stimulated more strongly to cope with influenza viruses. According to the vaccine recommendation adopted by the HAS on May 20, 2020, “in the case of a vaccine inducing better protection in the elderly compared to standard dose trivalent vaccines, Efluelda can be used, like other influenza vaccines, depending on its Marketing Authorization, either from the age of 65 as part of the French vaccine strategy against seasonal influenza, the objective of which is to reduce severe forms and deaths. No data is available in other special populations such as immunocompromised subjects, or adults under 65 at risk of severe influenza and eligible for vaccination recommendations “. Recall that the influenza vaccination is recommended annually because of the duration of immunity conferred by the vaccine and because circulating strains of influenza virus may change from year to year.
What is its mode of administration?
The administration of this vaccine is preferably intramuscularly. However, the subcutaneous route can also be used, says the laboratory. “The intramuscular injection is preferably done in the deltoid region. This vaccine should not not be injected into the buttock, or in areas that may be the site of a major nerve trunk“, specifies the vaccine leaflet. The administration of the influenza vaccine can be done at the same time as the vaccination against Covid-19, but to one in each arm according to the HAS.
What are the side effects?
Like all medicines, Efluelda vaccine is associated with a risk of side effects. The most common side effects (≥1 / 10) include: pain or erythema (redness) at the injection site, discomfort, myalgia or headache.
What are the contraindications?
The administration of this vaccine is contraindicated in cases ofhypersensitivity to active substances, to one of the excipients or to any constituent which may be present in trace amounts such as eggs (ovalbumin, chicken proteins) and formaldehyde. It should not be used in patients with acute febrile illness until the fever resolves. As with other vaccines given by the intramuscular route, this vaccine should be administered with caution to patients with thrombocytopenia or a coagulation disorder, as bleeding may occur following intramuscular administration in such persons.
What is its price and reimbursement?
The public price of the Efluelda vaccine is 30.25 euros, against around ten euros for standard vaccines (Vaxigrip Tetra, from Sanofi and Influvac Tetra from Mylan). He is reimbursed by Social Security for the populations defined by the vaccination recommendations in force:
- 100% via a cover slip sent by Health Insurance or printed by the Health Professional.
- 65% on medical prescription
– Efluelda sheet of the Haute Autorité de Santé (July 1, 2020)
– Our vaccines – Efluelda – Sanofi Pasteur Europe