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High-load influenza vaccines have been shown to be effective in people over 80 years of age. The target now is the age group between 65 and 79 years. The General Directorate of Public Health of Galicia and the Health Institute of Santiago (IDIS) have launched the Galflu study, a real-life clinical trial for this purpose.
There have been studies demonstrating the effectiveness of high-burden influenza vaccines compared with traditional vaccines. Galflu attempts to take a new step in the knowledge of immunity against this respiratory virus. The trial will last two years and has enrolled 60,000 people. Randomly, 30,000 subjects received the high-load vaccine and an additional 30,000 subjects received the traditional quadrivalent vaccine. When the flu season ends, around May, preliminary results will be analyzed that could confirm the convenience of high-burden flu vaccination among those aged 65 to 79 years.
The vaccine already has two decades of data and proven safety, with more than 243 million doses distributed
This clinical trial has advantages over other studies. Its implementation in real life. The vaccine already has two decades of data and proven safety in clinical development or post-marketing surveillance, with more than 243 million doses distributed in the 2022/23 season. The data obtained will assist public health authorities in their decision-making. “It allows public health decisions to be made in a more real and day-to-day context. “Galflu can provide us with information about the Galician population directly, but by using rigorous methods all the data can be extrapolated to what they want to consider or other countries in the decision-making process,” Explaining Underlining in Interviews health management Dr. Federico Martinón, sponsor and principal investigator of the trial.
There is already a precedent for Galflu, namely the Danflu study in Denmark. The Danish project collected data on 12,477 people aged 65 to 79 and came to clear conclusions. These high-load vaccines are designed to better prevent influenza infection, with a relative efficacy of 24.2% higher than standard-dose vaccines; and associated complications, with a 27.8% reduction in hospitalizations for pneumonia and a 16.7% reduction in hospitalizations for cardiovascular complications. %, and all-cause hospitalizations decreased by 8.2%.
Reduce hospitalizations
Meta-analysis shows high-load vaccine reduces influenza hospitalizations by 24% compared with standard vaccine J Li et al. Evaluating the efficacy and effectiveness of high-dose influenza vaccines in older adults through circulating strain and antigen matching. This work brings together 6 randomized and 15 observational studies across 12 seasons to show that high-load vaccines are more effective than traditional vaccines in reducing clinical outcomes associated with influenza infection in older adults, Regardless of the outcome of the analysis. , antigen matching, study type, study setting, and age subgroups.
Reductions in hospital admissions will have a significant impact on the quality of life of vulnerable patients and the sustainability of the health system. Between 2008 and 2018, 37 million people were hospitalized with influenza in Spain. Patients over 65 years old accounted for 65.6% of the total. The annual costs associated with these admissions to the national health system as a whole amount to €45.7 million. Faced with the impact of vaccine-preventable diseases, the European Commission emphasizes that vaccination is one of the most cost-effective public health tools. In fact, in the 2019/20 season, flu vaccination in people over 65 years old could prevent 26% of hospitalizations, 40% of ICU admissions and 37% of deaths.
High-load vaccine reduces influenza hospitalizations by 24% compared with standard vaccine
Both Galflu and Danflu use observational and stochastic methods. Such trials are seen as future alternatives for public administrations in designing their strategic public health plans. “Pragmatic clinical trials mark the before and after. Increasingly, we will see this type of research as a more common tool, not just for influenza vaccines, but for other vaccines and treatments. This way we can really look at immune effects in a real-world setting with the same rigor as a clinical trial, but also with the ability to include a large number of samples.”, highlights the study’s principal investigator.
Due to its high vaccination coverage, Galicia provides a favorable environment for such research. The autonomous region’s vaccination rate is 70%, which is higher than the national average. “Traditionally, the acceptance of vaccines in Galicia has been very high, not least because we currently have objectively the most complete and advanced schedule in the world. People also understand it as an opportunity to be healthy, live longer and live better.”, concludes Dr. Martinón.