Fluenz Tetra


Manufacturer: MedImmune/AstraZeneca Generic name: Influenza vaccine (live attenuated, nasal) Fluenz Tetra Safety The European Medicines Agency considers the safety profile of Fluenz Tetra as similar to Fluenz, its predecessor. It says it did not know whether repeat use of the vaccine may cause allergic reactions, nor whether the rate of serious side-effects can be adequately measured with the proposed post-authorisation safety studies. But they conclude: “However the ten years long marketing experience in the US has not raised major concerns for the time being.” The EMA previously evaluated safety trials for Fluenz and considered it safe. A study published in 2008 looked at increased risk to children “with history of intermittent wheezing” and found no increased risk from the vaccines. [1] Other studies similarly looked into vaccines and the risk from acute respiratory illness and found no link. [2] Conversely, a large study published in 2004 found: “For reactive airway disease a significant increased relative risk was observed in children 18 to 35 months of age…The individual diagnostic categories of upper respiratory infection, musculoskeletal pain, otitis media with effusion and adenitis/adenopathy had at least one analysis that achieved a significant increased risk ratio”. [4] 
Children are also almost twice as likely to suffer gastrointestinal symptoms after vaccination as the placebo group, mainly after the first dose, but much less so after subsequent doses. [3] These examples are typical for the data available, which varies widely from publication to publication and often arriving at opposing results. The US Vaccines Adverse Events Reporting System (VAERS) currently contains 5500 events for this type of vaccine from this manufacturer. About a fifth were classified as serious. Worst case, if all the reports were confirmed and assuming an under-reporting ratio of 5 in 100, this would make around 20,000 serious adverse events out of millions…

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