martes, 15 de octubre de 2013

QIVs to zap flu market | Pharmalive

QIVs to zap flu market | Pharmalive

QIVs to zap flu market

By Mia Burns (mia.burns@ubm.com)
Pharma companies will roll out new quadrivalent vaccine variants to replace traditional trivalent vaccines in a move that is expected to transform the seasonal flu vaccine landscape, according to independent analyst Datamonitor Healthcare. Quadrivalent vaccines provide the advantage of incorporating two influenza B strains, offering a wider scope for protection. The introduction of quadrivalent vaccines will give the vaccine market a much needed shot in the arm as all the major pharma players develop or launch their own variants and strongly promote the switch from trivalent vaccines.
Datamonitor Healthcare says that the existence of two B lineages in circulation at any one time can lead to difficulty in predicting which will be predominant in the upcoming flu season. Trivalent vaccines only include one B strain, and are vulnerable to mismatch with the predominant circulating B lineage. Quadrivalent vaccines eliminate this issue with the inclusion of strains from both circulating B lineages.
Michael Haydock, analyst at Datamonitor Healthcare, says that the main driver for the development of quadrivalent vaccines is the potential for B-lineage mismatch when trivalent vaccines are used, for example, the predominant circulating B strain does not match the B strain included in the vaccine.
“This has occurred in the U.S. in five out of 10 seasons from the 2001-2002 season to the 2010-2011 season,” Haydock told Med Ad News Daily.  “Mismatch reduces the effectiveness of seasonal vaccination because vaccinated individuals are unlikely to be producing the correct antibodies against the circulating B strain and are therefore vulnerable to infection and complications. Although clinical trials have only shown that quadrivalent influenza vaccines have non-inferior efficacy to trivalent vaccines, it is likely that when used in the larger population quadrivalent vaccines will demonstrate superior protection.”
Haydock also says, “Pharma companies are expected to discontinue trivalent vaccines once quadrivalent vaccines have been adopted in most patients as there will be no clinical reason to continue the use of trivalent vaccines once the swap has occurred. It is also more practical for pharma companies to do this because manufacturing capacity is limited and as quadrivalent vaccines have higher premiums than trivalent vaccines it is more profitable for companies to devote their resources to the production of these vaccines. MedImmune has already confirmed that it will only offer FluMist quadrivalent vaccine this season and we would expect GlaxoSmithKline to do the same for FluLaval and Fluarix in the 2014/2015 season if demand is high enough.”
In addition, as temperatures start to drop, analysts have delivered another grim forecast with 17 percent of people in the United Kingdom set to be hit by the flu virus this year.  Datamonitor Healthcare figures indicate that 10.5 million Britons will be struck by the debilitating illness this season, which traditionally lasts from October to March. The United Kingdom is also expected to see these numbers continue to rise over the next eight years.
“Based on available Phase III data, quadrivalent vaccines have shown comparable safety profiles to trivalent vaccines,” Haydock told Med Ad News Daily. “The tolerability/safety profile is unlikely to be the differentiating factor between quadrivalent vaccines and trivalent vaccines; instead developers are more likely to emphasize the potential for extra protection if quadrivalent vaccines are used.”
The prices of vaccines have become very low while competition is strong, Haydock says. “As quadrivalent vaccines are priced at a premium to trivalent vaccines, they are expected to boost profits and provide a temporary way for leading companies to differentiate new quadrivalent vaccine products from other players who are yet to launch them,” he told Med Ad News Daily.  “In the United States, GlaxoSmithKline has priced its Fluarix quadrivalent vaccine at a 50 percent premium over the trivalent vaccines version and Sanofi Pasteur has stated it expects premiums of 50 percent or more.”
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