- The recent unveiling of Fluad, the first influenza vaccine enriched with an adjuvant, highlights important advancements in the vaccine industry.
- An adjuvant is a substance meant to enhance the body’s immune response after vaccination, and Fluad includes the adjuvant MF59, a product derived from squalene oil.
- Approval for Fluad was based on comprehensive international clinical trials involving over 7,000 participants aged 65 and above, showcasing its effectiveness and safety.
- Fluad presents an alternative, safe and effective flu vaccine specially designed for individuals aged 65 years and older, a demographic known for their higher susceptibility to severe influenza.
- Fluad has already been in use in Italy since 1997 and is currently approved in 38 countries.
The milestones in the vaccine industry continue to make headlines with the unveiling of the foremost influenza vaccine featuring an adjuvant, granted approval for use in senior citizens by the U.S. Food and Drug Administration.
What is an Adjuvant?
An adjuvant represents a substance incorporated into vaccines with the sole purpose of bolstering the body’s immunological response post-vaccination.
Unveiling Fluad: An Overview
Fluad is defined as a trivalent vaccine, signaling its synthesis from three flu virus strains. In addition to these strains, Fluad also features the adjuvant MF59, crafted from squalene oil – a naturally-occurring substance found across humans, animals, and plants.
Backing Up Fluad’s Approval with Clinical Trials
The approval of Fluad pivots on the findings of a comprehensive international clinical trial encompassing over 7,000 participants aged 65 and above. These individuals received either Fluad or Agriflu, another trivalent seasonal influenza vaccine. Both vaccines elicited similar immunological responses across the trial participants.
Concluding results from the trial deemed Fluad as safe with the most prevalent side effects being pain and tenderness at the injection site, muscle aches, fatigue and headaches.
Fluad’s Importance in Advanced Years
“Fluad establishes an alternative avenue for a safe and effective influenza vaccine designed for individuals aged 65 years and older,” shared Dr. Karen Midthun, the director of the FDA’s Center for Biologics Evaluation and Research.
“The immunization of this age group holds particular significance given their heightened susceptibility to severe influenza disease, leading to majority of influenza-related hospitalizations and deaths.”
The Impact of Flu on Seniors
In recent times, the demographic aged 65 and over constitutes between 80-90% of seasonal flu-linked fatalities and between 50-70% of flu-induced hospitalizations across the United States.
Fluad, a product of Novartis, has been utilized in Italy since 1997, and currently holds approval in 38 countries.
For more insights on seasonal flu vaccinations, visit the U.S. Centers for Disease Control and Prevention’s website.