Sandoz Pvt. Ltd. (Novartis India)
The United States Food and Drug Administration (USFDA) approved the first seasonal flu, animal cell cultured vaccine – Flucelvax. The vaccine is indicated for the prevention of seasonal influenza in adults aged 18 years and over. The vaccine development process is similar to fertilized chicken egg method with few procedural differences. The viral strains are grown in animal cell lines instead of chicken eggs.
The vaccine is developed by Vaccines and Diagnostics Division of Novartis, Germany.
According to Dr. Karen Midthum, Director, FDA’s Center for Biologics Evaluation and Research, the approval is a significant step as a result of research efforts that developed from an alternate source – animal cell cultured influenza vaccine. Cell culture technique is an alternative to egg-based vaccine development with considerable advantages like readily-available supply sources, pre-tested and characterized animal cells for vaccine manufacturing and enables accelerated manufacturing in events of pandemic outbreaks.
A randomized, placebo-controlled clinical trial has been conducted in Europe and US with 7700 participants, aged between 18-49 years. The participants received either placebo or Flucelvax. When compared to placebo, 83.8% of effective prevention was achieved in Flucelvax- received volunteers. In volunteers aged over 49 years, an elicited antibody response was observed. The immunogenic response is better than chicken egg-based seasonal influenza vaccine, Agriflu.
The safety profile of the vaccine was evaluated in 6700 Flucelvax-received volunteers. The commonly reported adverse events were injection-site reactions including pain, rashes, redness, soreness, headache and general weakness.