will we be able to protect babies next winter? – The Express

Six months later, the hopes of defeating this respiratory infection this year have lost their luster, damaged by the French epidemic figures, the latest of which were published this Wednesday, November 8 by Public Health France. The start of winter is not as dark as that of 2022 – a record year – but the seasonal epidemic promises to be very intense despite the medical revolution announced by specialists in the United States and around the world. Some 3,870 children under the age of two have been admitted to the emergency room because of bronchiolitis over the last seven days, including 25 in intensive care. Thirteen regions are now in the “epidemic” phase. A similar assessment in the fall of 2021 and much higher than those of the years 2015 to 2019 at the same period, years when no effective vaccine against this disease had yet been discovered or distributed.

Authorized in Europe since October 2022, Beyfortus (nirsevimab) from Sanofi and AstraZeneca is one of the drugs that was expected to be a game-changer. Launched in September in anticipation of winter, the distribution of this monoclonal antibody in French pharmacies was suspended a few weeks later. Only newborns and hospitalized infants under one month old can currently benefit from it, due to a lack of available stocks this year.

The French State had, however, ordered 200,000 doses of Beyfortus at the beginning of 2023. The public authorities thus wanted to ensure the availability of the product this year, outside the normal framework of market access. The usual deadlines for examination by the High Authority of Health and then negotiation of prices by the Economic Committee for Health Products would not have otherwise allowed for massive distribution this year.

The government order was to meet the demand of 30% of eligible parents, according to statements by Minister of Health Aurélien Rousseau. Usually, membership is only 10% for this type of new product. Except that, from the first weeks of the campaign, more than 60% of young parents wanted it. A “never before seen” craze, in the memory of pharmacists and manufacturers, and therefore impossible to predict, the Ministry of Health and Sanofi agree. Until now, injections for toddlers have tended to be scary, due to numerous misinformation campaigns about them.

In fact, discussions with Sanofi on the price are still ongoing and are not expected to conclude in the spring. Asked about the availability of Beyfortus in the future, particularly for next winter, Sanofi defers to French institutions: “The number of doses that Sanofi will sell to France will depend on how the State wants to proceed, selected distribution channels, which can go through the classic wholesaler – pharmacist duo, or through state stocks, which allows for example finer monitoring and therefore more precise data.

These same French institutions must also resolve the issue of the Abrysvo vaccine from the Pfizer laboratory. Authorized since August 25 by the European Medicines Agency, intended for pregnant women directly (who transmit their antibodies to their baby), it is still not available in France. The recommendations of the High Authority for Health (HAS), necessary to obtain reimbursement and thus hope to reach as many people as possible, will not be available until May 2024 – the bronchiolitis epidemic will have already ebbed.

At Pfizer, these delays are surprising: “Beyond leading to one of the leading causes of hospitalization of infants, the epidemic contributes to the congestion of hospital services, which seems to us to be a criterion of public health emergency” , indicates David Lepoittevin director of the vaccines activity. The American, English and even Australian authorities have already given their opinion, underlines the company, which shared its data with HAS last May. If it should nevertheless be available to protect babies next winter, the same will not be true for the elderly, also affected by RSV, against which Abrysvo immunizes: the High Authority of Health will examine the file to this indication only from October 2024. In the meantime, these products are not available.

Pfizer is not the only laboratory to have to wait. In the same situation, GSK decided to market its Arexvy vaccine for seniors without delay. Without advice from the HAS, the product, which has benefited from authorization from the European Medicines Agency since June, cannot be covered. It is therefore sold for €230 per dose, which patients must currently pay out of their own pocket if they wish to protect themselves. Too slow, the HAS? The institution recalls that the industrialist’s files were not handed over to it until July 2023. It was also on this date that Moderna handed over its own. Its product, a vaccine, also for seniors, nevertheless benefited from an accelerated procedure in the United States, because it was deemed potentially “revolutionary” by the American authorities.

Faced with pressure from patients and doctors, the president of the HAS had to remind us last October of the time necessary for the most careful study of pharmaceutical products: “Developing vaccine recommendations requires a very strict methodology, which leads, what whatever countries wish to respect it, with deadlines of the order of 9 to 12 months”. While also suggesting that the independent institution did not always benefit from the funds necessary for its most rapid functioning.

Why then not do as during Covid-19, where everything was transmitted and studied almost live? This was a major crisis, responds the institution. Bronchiolitis occurs in serious forms and contributes to flooding healthcare services every winter but causes very few deaths. And the announced revolutions do not always take place. It is not uncommon for the High Authority for Health to revoke certain products having obtained marketing authorization from the European Medicines Agency. Last June, for example, the institution recommended against Bimervax, a Spanish vaccine against the coronavirus. Pericarditis occurred during clinical trials. You might as well use the available vaccine alternatives.