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Influvac Tetra: clinical experience on safety, efficacy, and immunogenicity
Laura Colombo1, Sanjay Hadigal2, Jos Nauta3
1Global Medical Affairs, Viatris, Monza, Italy.
Insights
This study reviews the safety and immunogenicity of Influvac Tetra, a seasonal influenza vaccine, in all age groups from six months. Data from clinical trials support its use in preventing influenza complications.
Area of Science:
- Vaccinology
- Immunology
- Public Health
Background:
- Seasonal influenza is a significant vaccine-preventable disease with potential for severe complications.
- Various influenza vaccines exist, including egg-based, cell-based, and recombinant types, with ongoing innovation like mRNA vaccines.
- Despite available vaccines, influenza vaccination coverage remains below recommended levels, particularly in at-risk groups and healthcare workers.
Purpose of the Study:
- To summarize safety and immunogenicity data for Influvac Tetra from its clinical development program.
- To present findings across all age groups, starting from six months of age.
Main Methods:
- The study is based on five registration studies for Influvac Tetra.
- Studies included diverse age groups, comparators, and participants from Europe and Asia.
- Safety and immunogenicity were evaluated in all studies; efficacy was assessed in one study.
Main Results:
- Influvac Tetra demonstrated safety and immunogenicity across all evaluated age groups.
- Data were collected during the vaccine's clinical development program.
Conclusions:
- Influvac Tetra is a safe and immunogenic option for seasonal influenza prevention in individuals aged six months and older.
- The findings support the use of Influvac Tetra in clinical practice to improve influenza vaccination coverage.
Introduction:
This paper summarizes the safety and immunogenicity data of Influvac Tetra across all age groups starting from 6 months of age, obtained during its clinical development program.
Areas Covered:
The article covers the clinical development program of Influvac Tetra based on five registration studies that included different age groups, different comparators, and participants from Europe and Asia. Safety and immunogenicity were assessed in all studies and in one study, the efficacy of Influvac Tetra was assessed.
Expert Opinion:
Seasonal influenza is a vaccine-preventable disease that can cause serious complications. Several types of influenza vaccines are available, including egg-based (standard dose, high dose, and adjuvanted), cell-based, and recombinant. The COVID-19 pandemic has stimulated innovation in the development such as mRNA vaccines. However, these vaccines are still in development and the true value still has to be proven. Regardless of the type of vaccine, it is also important to increase overall vaccination coverage. ECDC recommends that EU Member States implement action plans and policies aimed at reaching 75% coverage in at-risk groups and healthcare workers. Even so, vaccine coverage is still far from recommended.
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