Months after its formation last fall, CSL's flu vaccines unit Seqirus is a loss-making entity. However, leadership there believes the operation can achieve "industry leadership" in 5 to 10 years by relying on a move into quadrivalent vaccines, the launch of Fluad and emerging markets growth.
Just in time for flu season, AstraZeneca granted Daiichi Sankyo an exclusive license to market its FluMist Quadrivalent in Japan. The live attenuated vaccine, delivered nasally, went through Phase III trials in Japanese children, and a regulatory submission is being prepared for Japan.
Protein Sciences released data showing that Flublok Quadrivalent--its follow-up to the FDA-approved trivalent Flublok--outperformed the traditional egg-based quadrivalent vaccine.
The current flu season should have provided the first opportunity to gauge the impact of quadrivalent vaccines. However, the extra B strain in the quadrivalent vaccines has been rendered irrelevant by the almost total dominance of H1N1.
Consumers faced an array of choices going into the current flu season, with quadrivalent vaccines being sold alongside high-dosage varieties and vaccines produced without eggs. Fourth-quarter results suggest people have taken up the new options, with sales at AstraZeneca, GlaxoSmithKline and Sanofi soaring.
Each holiday season the festivities in a notable minority of households are disrupted by flu. Typically infants and seniors are most at risk of severe illness, but occasionally a strain that disproportionately affects young and middle-aged adults emerges. Early evidence suggests 2013-2014 could be such a year.
The full effect of the introduction of quadrivalent flu vaccines is unlikely to become clear for several years, but this week saw the release of data that convinced the FDA to approve GlaxoSmithKline's vaccine. And while the benefit of the extra strain is unclear, the data makes a case for immunizing with any flu vaccine.
When MedImmune won approval for its quadrivalent nasal flu vaccine back in February 2012, it kicked off the battle to claim a share of the next-generation influenza immunization market. Now, almost two years later, its parent company AstraZeneca has the race underway in Europe, too.