Drug (Brand / Generic)
FluLaval (Influenza Virus Vaccine)
Company / Licensee
Hemagglutinin in the recommended ratio of 15 mcg
FluLaval is an influenza vaccine that was approved by the US FDA on 23 July 2010, for use on people who are 18 years and older to help protect them against influenza disease.
This vaccine was first manufactured and marketed in Quebec, Canada by ID Biomedicalfrom 1992 with the trade name Fluviral.In December 2005, GlaxoSmithKline (GSK) acquired ID Biomedical which was the original developer of FluLaval vaccine. With this acquisition, GSK became the owner of the drug license.
Influenza is an infectious respiratory disease commonly referred to as flu. The disease is caused by influenza viruses of the Orthomyxoviridae family, and generally affects mammals and birds.
The common indications of the disease are fever, sore throat, headaches, chills, coughing, weakness, fatigue, general discomfort and muscle pains. In some cases influenza can cause pneumonia, which could be a deadly disease especially for the young and the elderly.
The influenza virus is contagious and can be transmitted through coughs and sneezes. The disease can also be transmitted from one person to the other directly through contact with contaminated surfaces, or with nasal secretions and bird droppings.
Influenza results in death of 250,000 to 500,000 people around the world in a year. In the US alone, about 41,400 people have died of the disease each year on an average from 1979 to 2001.
According to the US Centres for Disease Control and Prevention (CDC) estimates, about 35m to 50m people in the US come down with the flu during each flu season.
FluLaval is an injectable split-virion influenza virus vaccine used as active immunisation for adults against influenza disease caused by influenza virus subtypes A and B. The vaccine is propagated in the allantoic cavity of embryonated hens’ eggs.
The vaccine contains a homogenized, sterile, phosphate-buffered saline solution. The vaccine is formulated with a hemagglutinin dosage in the ratio of 15 mcg.
GSK has conducted phase I clinical trials on FluLaval in Belgium in August 2008. The study enrolled 110 influenza patients and was targeted to assess a novel formulation of FluLaval. The preliminary data on the safety of the vaccine and its immune response in adult patients were also studied during the trials.
GSK conducted phase II clinical trials on FluLaval in Germany, the Netherlands, Sweden and the UK from October 2007 to July 2008. The study was designed to evaluate the immunogenicity, safety and reactogenicity of different formulations of FluLaval administered in adults aged 65 years and older compared to Fluarix.
The primary outcome measure of the trial was to find the number of subjects with hemagglutination inhibition (HI) antibody tier above the cut-off value. The secondary outcome measure was to assess the unsolicited adverse events during the 21 day post-vaccination period.
Phase III clinical trials on the FluLaval vaccine in the US were initiated in September 2006. The study enrolled more than 600 influenza affected people.
The key objective of the study was to describe the immunogenicity, safety and tolerability of FluLaval and Fluarix, the latter serving as an active comparator.
The results were compared to standard immune response criteria, for both young and elderly populations.
The FDA approval, which follows GSK’s acquisition of ID Biomedical Corporation, relates to both the vaccine and its production site. As a result, the approval of the vaccine significantly increased GSK’s potential production capacity for both seasonal and pandemic influenza vaccines. GSK now plans to bring more than 30m doses of flu vaccine to the US market for the current influenza season. The vaccine sales have increased by 8% in the US to £130m.