QIVs to Boost the Flu Vaccine Market

The seasonal flu vaccine landscape is about to be transformed as the traditional trivalent vaccines (TIVs) are replaced with new quadrivalent vaccine (QIV) variants, according to independent analyst Datamonitor Healthcare.

QIVs can incorporate two influenza B strains, offering much greater scope for protection. As there are two B lineages in circulation at any onetime it can be difficult to predict which will be predominant in the upcoming flu season. TIVs only include one B strain, and are vulnerable to mismatch with the predominant circulating B lineage. QIVs eliminate this issue, by including strains from both circulating B lineages.

The introduction of QIVs will provide the vaccine market with a much needed shot in the arm, with all the major pharma players developing or launching their own variants and strongly promoting the switch from TIVs.

Michael Haydock, analyst at Datamonitor Healthcare, says: “MedImmune’s intranasal QIV FluMist was approved in the US in February 2012 and will be available for the 2013/14 season for those aged 2–49. The company has announced that all vaccines supplied to the US for the upcoming season will be QIVs, indicating aggressive promotion of swapping from FluMist TIV to FluMist QIV. FluMist QIV is expected to be approved in the EU by Q1 2014.

“Sanofi Pasteur’s intramuscular Fluzone QIV was approved in the US in June 2013 for children aged 6 months and older, adolescents and adults. It is the only QIV approved for children as young as 6 months. Sanofi Pasteur is expected to distribute more than 60 million doses to the US this Autumn, and unlike MedImmune, will continue to offer older Fluzone TIV and high dose Fluzone variants. Within the EU, Sanofi is developing Vaxigrip, an intramuscular QIV which is expected to launch in Q3 2014.

“GlaxoSmithKline’s (GSK) Fluarix QIV was approved for children aged over 3 and adults in the US in December 2012, and in Germany and the UK in April 2013.

“The alternative FluLaval QIV was approved in the US in August 2013 for those aged 3 and over. FluLaval TIV is only approved for people aged 18 and over, and therefore the approval of the new QIV version expands GSK’s target sales population.

“GSK is expecting to distribute up to 10 million doses of its QIV vaccines this autumn in the US, with 8 million expected to be Fluarix QIV. GSK will also continue to offer Fluarix and FluLaval TIV variants, but anticipates rapid switching to QIVs during the next 2 years.

“Novartis is yet to bring a QIV to market, but the company intends to initiate Phase III trials of Fluad QIV in the elderly (aged 65 and over) at the end of 2013.”