The ANSM has just granted marketing authorization (AMM) in France for Efluelda, Sanofi’s high-dose influenza vaccine, in its trivalent version. The laboratory hopes to return to France from the 2025-26 flu vaccination campaign [1].
A quantity of antigens four times greater
Developed with a quantity of antigens four times greater than that of a standard dose vaccine for each vaccine strain, the high dose Efluelda vaccine is suitable for adults aged 60 and over, whose immune system effectiveness declines with age, offering them better protection against the flu and its complications.
In fact, in the week following a flu infection, the risk of stroke is multiplied by 8 and the risk of myocardial infarction is multiplied by 10. 23% of those aged 65 and over experience a loss of autonomy within the month following hospitalization due to influenza. Efluelda is the only influenza vaccine to have proven better effectiveness compared to the standard vaccine, on the basis of numerous clinical data, from randomized controlled clinical trials in the elderly, as well as from efficacy data in real life, and this observed over more than 11 seasons, in more than 45 million people.
The recent study Driven conducted in France provides new real-life data on the French population: on the basis of Health Insurance registers, covering more than 7,800,000 people, over the 2021-2022 season, it estimates the relative vaccination effectiveness of high-dose quadrivalent vaccine compared to the standard vaccine in people over 65 years of age. In this real-life study, people vaccinated with the high-dose vaccine had 23.3% fewer hospitalizations for influenza compared to people who received the standard vaccine.
Trivalent formula expected for the 2025-26 season
This new Marketing Authorization for Efluelda aims to respond to the recommendation of theWorld Health Organization (WHO) a return to trivalent flu vaccines. Indeed, the B/Yamagata strain is no longer circulating in the world, maintaining quadrivalent vaccines is no longer necessary. The European Medicines Agency (EMA) has confirmed this change and asked vaccine manufacturers to make trivalent influenza vaccines available for the 2025-26 season.
The high-dose Efluelda vaccine, already available in quadrivalent form in more than 20 countries. However, due to disagreement over pricing with the State, Sanofi’s high-dose Eflueda influenza vaccine, intended for seniors, will not be available this year. Vincent ArolesMedical Director of Vaccines at Sanofi France, specifies in a press release [1] continue “the dialogue with the authorities to allow Efluelda to be available on the French market from the next flu season”.
