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A vaccine against cervical cancer has been approved by US health officials after two years of waiting.
GlaxoSmithKline’s vaccine Cervarix is already used in Europe, but its application for approval in the US was delayed in 2007 when the Food and Drug Administration (FDA) said it required more information.
Now the FDA has accepted that Cervarix is safe for girls and women aged between 10 and 25, and said it successfully blocks the virus that leads to cervical cancer developing.
Although it voted overwhelmingly in favour of the vaccine, the group also recommended follow-up studies to monitor reports of miscarriages and inflammatory-muscular problems by some patients.
Panellists said the vaccine was unlikely to be the cause of these problems but should carry a warning on the product label.
“This wasn’t a pregnancy trial and it wasn’t meant to be used in pregnancy, it just happened accidentally,” said Dr. Kenneth Noller, of Tufts University. “I think this could be marketed with the usual caveat that it’s not to be used in pregnancy.”
Merck’s vaccine Gardasil has controlled the US market since 2006, but the FDA may now allow GlaxoSmithKline to compete.
Copyright Press Association 2009
