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FDA approves Sanofi's four-in-one flu vaccine

But wants more safety data for hepatitis B vaccine from Dynavax

Sanofi Pasteur building

It was a mixed week for vaccine makers in the US as the FDA approved use of Sanofi's four-in-one influenza vaccine but requested more data from Dynavax for its hepatitis B vaccine.

Sanofi Pasteur, the vaccines division of Sanofi, received a recommendation for its Fluzone Quadrivalent vaccine for use in children six months of age and older, adolescents, and adults to protect against four strains of influenza.

It becomes the third major four-strain influenza vaccine approved in the US following FDA backing for AstraZeneca's FluMist Quadrivalent in March 2012 and GlaxoSmithKline's (GSK) Fluarix Quadrivalent nine months later.

Each vaccine offers protections against two strains of influenza A and two of influenza B, expanding on standard trivalent seasonal influenza vaccines that offer protection against one strain of influenza B.

Public health systems are gradually moving towards a four-strain approach to influenza protection, as during a during a typical influenza season, there may be two different influenza B strains circulating, or the B strain selected for inclusion in the trivalent influenza vaccine may not be the influenza B strain that eventually circulates causing illness.

According to Sanofi, the Fluzone Quadrivalent vaccine will be available to healthcare providers in the US for the 2013-2014 influenza season.

Although it is the latest four-strain vaccine to market, Fluzone Quadrivalent's approval for use in children as young as six months does give it small advantage over FluMist Quadrivalent, which is approved in people aged two to 49, and Fluarix Quadrivalent, which is approved in people aged three and over.

FDA wants more safety data for hepatitis B vaccine
Meanwhile, Dynavax received less positive news from the FDA as the agency requested more safety data from the company to support its marketing application for the hepatitis B vaccine Heplisav.

In a meeting between the two organisations to discuss Dynavax' Biologic License Application (BLA) for Heplisav, the FDA said there was a “shortfall in the safety database” that wasn't adequately covered by Dynavax' proposal to analyse data in discrete patient populations.

According to Dynavax, the FDA informed the company “that to do so would unnecessarily restrict the patient population that could benefit from Heplisav's approval”.

Eddie Gray, CEO of Dynavax, said the company appreciated “the informative interactions and clarity” provided by the FDA.

"We understand the rationale for the Agency's recommendations and will give full consideration to their feasibility and timing as we advance Heplisav's development."

Dynavax will meet with the FDA shortly to discuss the protocol for collecting the additional safety data, which is expected to be incorporated into the existing BLA.

12th June 2013

From: Sales, Healthcare



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