MILAN – The Food and Drug Administration américaine (FDA) has given the green light to the administration of FluMist nasal spray flu vaccine at home by the patient or a loved one, without the intervention of a healthcare professional[1].
This vaccine, FluMist, was initially approved by the FDA in 2003 for use in people ages 5 to 49, and in 2007, the FDA approved the use of FluMist for children ages 2 to 5.
It is now the first flu vaccine that can be administered without a healthcare professional and its manufacturer hopes it will improve access to flu vaccination.
FluMist contains a weakened version of the flu virus and requires administration once a year.
FluMist protects against two common types of flu viruses, A and B, and is suitable for anyone aged 2 to 49.
Studies have shown that people aged 18 to 49 can successfully administer the vaccine just as effectively as a doctor or nurse, according to MedImmune, the AstraZeneca subsidiary that makes FluMist [2].
Peter Markswho directs the Center for Biologics Evaluation and Research (Center for Biologics Evaluation and Research) from the FDA, said the authorization provides more convenient options for people seeking protection against the flu.
People who want to use FluMist at home will still need a prescription. However, the vaccine will soon be available through an online pharmacy.
AstraZeneca said that after going through a process to confirm their eligibility, patients will receive their prescription and have the FluMist shipped directly to their home, along with detailed instructions on how to store and use it.
FluMist will also remain available in doctor’s offices and pharmacies.
For children ages 2 to 17, the FDA recommends that a parent or caregiver administer the spray. Common side effects include a runny or stuffy nose, fever in young children, and sore throat in adults.
Available in France?
FluMist Quadrivalent is identical to the Fluenz Tetra vaccine which is no longer marketed in France to date.
Note that the European indication for Fluenz Tetra (2-18 years) is more restricted than that of the United States (2-49 years).
Asked by Medscape French edition on the availability of the vaccine, the AstraZeneca laboratory stressed that the vaccine was “already available in its tetravalent form in several European countries for years” and that “its benefits for the acceptability and therefore the effectiveness of vaccination children have been demonstrated, particularly in the United Kingdom where it is widely used” and that it also indirectly protects the vulnerable population. “In France, it is currently being evaluated by the HAS, which had recommended it preferentially in 2022, despite its absence in France.”
The laboratory hopes to be able to finalize the discussions [sur le prix] as quickly as possible to allow its use in France within a time frame compatible with the next epidemic season. “Orders must in fact be placed at least 6 months before the start of production, taking into account demand and incompressible production deadlines,” specifies AstraZeneca.
This article was translated from Medscape.com using multiple editorial tools, including AI, in the process. The content was reviewed by the editorial staff before publication.
