Why France is in a bad mood with Sanofi’s new flu vaccine

Bronchiolitis but also nasopharyngitis, tonsillitis, gastroenteritis … The seasonal viruses that Covid-19 had forgotten return at the end of the year. And especially the flu, which could make a spectacular comeback, after being almost forgotten last year. Due to health restrictions, including confinement, the virus circulated less than usual in 2020. During the entire season last year, the 226 intensive care units reported no severe cases of influenza, compared to 860 severe cases reported during the season. previous (2019-2020), Public Health France (SpF).

For this winter season 2021-2022, “great uncertainty remains about the appearance of a seasonal flu epidemic in France, its timing and its impact on the population and the health system,” warns SpF. This will depend, in particular, “on the level of effectiveness of the influenza vaccines against the viruses that will circulate and on the vaccine coverage of the target populations,” the health authorities add.

No specific recommendation in France

A new vaccine from the French laboratory Sanofi-Pasteur, called Efluelda, was authorized in September 2020 by the European Medicines Agency (EMA) for people over 60 years of age and made available for the vaccination campaign that begins on October 26. A promising and more effective vaccine than those already proposed, Vaxigrip Tetra, also from Sanofi-Pasteur, and Influvac Tetra from the Mylan laboratory. But unlike Germany, which has reserved the French vaccine for everyone over 60, the French authorities have not issued any specific recommendations.

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In France, flu vaccination is reimbursed to those over 65, who will receive one of three vaccinations without distinction. “Effluelda peut être used, au même titre les autres vaccins grippaux, selon are authorization of mise sur le maré, soit from the age of 65 years from the cadre of the strategie vaccinale française vis-à-vis de la grippe Saisonnière dont l’objectif est de réduire les formes graves et les décès “, specify the Haute autorité de Santé (HAS) dans are avis dating from June 2020. Ce qui n’exclut pas une utilization pour les 60-65 ans, à condition to pay.

Too high a cost

If the Sanofi product is not so popular in France, it is probably also because of its price: the High Health Authority blocks the higher cost of Effluelda, at 30.25 euros compared to ten euros for the other two. According to Les Echos, “immunizing all people over 65 with Effluelda would increase the budgetary impact (undisclosed) by 49.6% and spending on vaccine purchases (undisclosed amount) by 197%.” A bit too salty addition for the authorities.

But how does Efluelda differ from its competitors? It is a “quadrivalent influenza vaccine known as inactivated”, explains the laboratory at the origin of its manufacture. It is also said to be “high dose” because it has four times more antigens per strain than the other vaccines on offer. While this dose is already used in the United States and Canada, this is the first time it will be administered in Europe.

“Beyond an additional benefit in protecting against influenza compared to the standard vaccine, the new vaccines should also demonstrate better prevention of hospitalizations for cardiovascular causes and pneumonia,” said Marie-Cécile Levant, medical manager of Influenza vaccines Sanofi Pasteur France, during a press conference. Effluelda shows a superior efficacy of almost 18%. “Assuming a vaccination coverage of 50% in the target people, the laboratory estimates the impact of the introduction of the vaccine in France in a reduction of 57,000 cases of influenza, 18,000 hospitalizations and 700 deaths per year.

However, the health benefits do not correspond to the costs incurred, according to the HAS: “The very low impact on health outcomes and the organization of care does not justify such an increase in the cost of purchasing the vaccine. which implies the need for a strong price reduction “.

A new chance to shine

The French laboratory, which has already launched the first trials of a monovalent RNA vaccine, with a single strain of the virus, against seasonal flu, said on Tuesday that it wanted to launch clinical trials against influenza next year, with a new quadrivalent vaccine. An opportunity also to compensate for the failure of his serum against Covid-19. In this global vaccine race, the tricolor giant has lost its date in history.

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In its defense, the French laboratory is the only major player in the pharmacy that has launched itself into the battle against Covid-19 by developing its own vaccines, also with two projects. But this initial ambition was overcome by the difficulties that characterize the long-standing group: cumbersome and late internal decisions.

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