(CIDRAP) – Europe's drug regulatory agency today released its final review of a link between narcolepsy and the Pandemrix 2009 H1N1 vaccine, which recommends a labeling change that limits the vaccine's use in children and teens to when protection is needed and seasonal trivalent vaccine isn't available.
(CIDRAP News) The European Medicine Agency (EMA) said today it is not clear if there is any link between narcolepsy cases and the Pandemrix vaccine for 2009 H1N1 influenza, and it will take 3 to 6 months to investigate the possibility fully.
(CIDRAP News) Large trials in three countriesthe United States, Hungary, and Chinarecently confirmed the safety and efficacy of H1N1 vaccines, yielding new insights on how to best use vaccines in a pandemic setting.
(CIDRAP News) – The era of cell-based influenza vaccine production in the United States seemed to move closer today as Novartis unveiled its new, nearly billion-dollar manufacturing plant in Holly Springs, N.C., but onshore production and marketing of cell-based vaccines remains a few years away.
(CIDRAP News) Questions about the tardy US supply of pandemic H1N1 vaccine have increased with the report that most of Novartis's doses may not reach the country until early in 2010 and a European regulatory recommendation that may have implications for the global vaccine supply.
(CIDRAP News) The World Health Organization (WHO) said today that the fast-tracking of vaccines for pandemic H1N1 influenza won't compromise safety, while acknowledging that clinical data will be limited when the first doses are administered.
(CIDRAP News) This in-depth article investigates the prospects for development of vaccines to head off the threat of an influenza pandemic posed by the H5N1 avian influenza virus. Its seven parts put advances in vaccine technology in perspective by illuminating the formidable barriers to producing an effective and widely usable vaccine in a short time frame.