Contraindications for Fluenz are as follows:1
- Hypersensitivity to the active substances or, to any of the excipients listed in section 6.1 of Fluenz SmPC or to gentamicin (a possible trace residue).
- Severe allergic reaction (e.g. anaphylaxis) to eggs or to egg proteins (e.g. ovalbumin).
- Children and adolescents with clinical immunodeficiency due to conditions or immunosuppressive therapy such as acute and chronic leukaemias, lymphoma, symptomatic HIV infection, cellular immune deficiencies, and high‑dose corticosteroids. Fluenz is not contraindicated for use in individuals with asymptomatic HIV infection, or individuals who are receiving topical/inhaled corticosteroids or low‑dose systemic corticosteroids, or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.
- Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild‑type influenza infection (see section 4.5 of SmPC).
Other warnings and precautions for the use of Fluenz:1
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Hypersensitivity and anaphylaxis
As with most vaccines, appropriate medical treatment and supervision should always be readily available to manage an anaphylactic event or serious hypersensitivity event following the administration of Fluenz.
Concurrent illness and chronic conditions.
Fluenz should not be administered to children and adolescents with severe asthma or who are currently wheezing, because these individuals have not been adequately studied in clinical studies (see section 4.8 of SmPC).
Administration of Fluenz should be postponed in individuals suffering from severe acute febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not result in the deferral of vaccination.
Vaccination should also be postponed in individuals with nasal blockage, due to the potential for reduced vaccine uptake and the absence of efficacy data in this population. The presence of mild symptoms of a common cold without nasal blockage should not result in the deferral of vaccination.
Immunocompromised individuals
Vaccine recipients should be informed that Fluenz is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts. Vaccine recipients should attempt to avoid, whenever possible, close association with severely immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation) for 1‑2 weeks following vaccination. Peak incidence of vaccine virus recovery occurred 2‑3 days post‑vaccination in clinical studies. In circumstances where contact with severely immunocompromised individuals is unavoidable, the potential risk of transmission of the influenza vaccine virus should be weighed against the risk of acquiring and transmitting wild‑type influenza virus. The effectiveness of Fluenz preventing influenza disease in immunocompromised individuals has not been evaluated (see section 4.8 of SmPC).
- Gelatine: this nasal spray flu vaccine uses porcine gelatine (derived from pigs) as a stabiliser to temperature protect the vaccine; this is used globally in a wide range of medicines and some vaccines15,16
- This information is taken from the NHS regarding the views of faith communities:15
- The UK Health Security Agency (UKHSA) has consulted with the Kashrut and Medicines Information Service, who said: ‘It should be noted that according to Jewish laws, there is no problem with porcine or other animal derived ingredients in non-oral products. This includes vaccines, including those administered via the nose, injections, suppositories, creams and ointments’
- The Oxford Vaccine Group states:16
- Members of Muslim or Jewish religious communities may be concerned about using vaccines that contain gelatine from pigs (porcine gelatine). According to Jewish laws, there is no problem with gelatine or any other animal substance if it is used in a product that does not go into the mouth. Some Muslim leaders have also ruled that the use of gelatine in vaccines does not break religious dietary laws, because it is highly purified and it is also injected or inhaled rather than ingested (eaten)
- For further information about porcine gelatine and the nasal spray influenza vaccine, see the government information:
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/751199/Vaccines_porcine_gelatine.pdf.
- The decision is, of course, up to the parents or carers of your patient, respecting the diversity of their beliefs
Pregnancy and breast-feeding
Fluenz is not recommended during pregnancy. It should not be used during breast-feeding.