Anti-bronchiolitis towards free for children, but now there are no doses for all

After the uproar in recent weeks overthe stop in some regions to the free 'vaccine' against bronchiolitis, the Ministry of Health is ready to make amends by including it in the national immunisation calendar alongside the already recommended vaccines. The aim is to make it free for children from zero to two years old. But it may be too late, both because the virus season has already begun, but above all because there are not enough doses to cover the potential demand, as the Regions have denounced and as the company that produces it confirms.

The respiratory syncytial virus can lead to severe cases of bronchiolitis in infants. Every year, it causes the death of about 100,000 children under the age of five worldwide. A breakthrough is represented by the monoclonal antibody that has proven to prevent 90% of hospitalisations and that the ministry has announced it will make available free of charge in all regions for the treatment of newborns. But the regions are pressing: we must act quickly, because the epidemic phase is just around the corner and at present there are no doses for everyone, with the risk of once again creating a scenario of 'serious inequality' across the country, 'with regions that have availability of the drug for a universal campaign and regions that fail to protect even fragile patients'.

The alarm over the availability of the monoclonal antibody nirsevimab comes from a letter sent to the Minister of Health, Orazio Schillaci, and to the Italian Medicines Agency signed by Raffaele Donini, a councillor from Emilia-Romagna, in his capacity as coordinator of the Health Commission of the Conference of Regions. Donini pointed out that many of the regional tenders carried out for the purchase of Nirvesimab 'have been unsuccessful because the company has declared that the drug is not available for universal coverage' and this has led to 'a scenario of serious inequality across the country'. In the face of these 'urgencies', the regions are asking to 'evaluate the activation of an accelerated negotiation by AIFA for the inclusion of the drug in Band A, thus making it accessible to all regions'. And if this is not possible, they ask for the possibility of attributing "reimbursability to Band C drugs purchased by the NHS bodies for public health needs".

In the meantime, the pharmaceutical company Sanofi, manufacturer of the monoclonal antibody drug, has let it be known that, 'even in the absence of historical indications on the prevention needs of individual regions, it has reserved for Italy doses that can guarantee approximately 75% coverage of the entire national birth cohort, based on scientific data on efficacy and epidemiological impact'. Starting in the next few days, Sanofi Italia will begin marketing nirsevimab in our country as well, starting distribution in the territory. However, 'as communicated to the Institutions, Authorities and Regions, at the current state of affairs and due to commitments already undertaken', Sanofi specifies that 'it is not in a position to respond to the regional public purchasing procedures underway and those that may be called in the coming weeks, although it will continue to make efforts to make additional doses available'.