US FDA recommends GSK’s flu vaccine for approval

As reported by The Pharma Letter, the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted unanimously in support of GlaxoSmithKline’s (GSK) vaccine in the treatment of influenza.

GSK contracted with the U.S government to develop the flu vaccine which contains antigen-sparing adjuvant that helps boosts the immune response.

The H5N1 vaccine has been developed to treat patients aged 18 years and older who are at increased exposure to the influenza. The vaccine, which is administered in two doses over 21 days, contains GSK’s proprietary adjuvant AS03 which is used to induce a stronger immune response. It has been designated for a national stockpile to be reserved for use during an avian influenza pandemic or outbreak, GSK has no plans to market the vaccine.

The GSK vaccine is currently approved in Europe under the brand name Pumarix. If approved in the US, it could become the first adjuvanted flu vaccine to win approval in the country.

Speaking of the good news, Bruce Innis, vice president, GSL Global Vaccines Discovery and Development stated, “GSK has been collaborating with the US Department of Health and Human Services since 2006 to develop this H5N1 vaccine and we are pleased with the positive vote recommending its approval. We now look forward to a final decision by the FDA later this year and to also continuing our collaboration with the US government on public health issues.”

 

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US FDA recommends GSK’s flu vaccine for approval US FDA recommends GSK’s flu vaccine for approval US FDA recommends GSK’s flu vaccine for approval US FDA recommends GSK’s flu vaccine for approval

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