Cervical cancer vaccines have been given a boost in the USA after an advisory panel there recommended approval of GlaxoSmithKline’s Cervarix, while Merck & Co’s Gardasil got a favourable nod to have its use extended to men
For GlaxoSmithKline, this could be the light at the end of the tunnel after the US Food and Drug Administration denied approval of the company’s Cervarix in 2007 and instead requested more information following reports the drug might lead to miscarriages in pregnant women.
According to the FDA advisory panel, the evidence linking the jab to miscarriages is weak but the panel suggested the vaccine should carry a warning of the possibility and recommended it for approval in women.
Meanwhile, Merck’s Gardasil, which has been approved for use in females aged 10-25 since 2006, was recommended by the panel to have its use extended to men between the ages of nine and 26. However, the panel conceded that because of the rarity of penile and anal cancer caused by the human papilloma virus, which the vaccine protects against, and the cost, many men will choose not to be vaccinated.
FDA approvals for Cervarix and Gardasil are expected by the end of this month and by the end of October respectively.
