Cervarix adverse reactions as expected, says MHRA
pharmafile | March 11, 2009 | News story | Sales and Marketing |Â Â GSK, vaccinesÂ
The government has played down reports about adverse reactions to GlaxoSmithKline's Cervarix, saying they are in line with expectations.
The Medicines and Healthcare Products Regulatory Agency (MHRA) said that the vast majority of adverse events related to the cervical cancer vaccine were due to recognised side effects.
It said that other side effects reported were likely to be psychogenic in nature, caused by the injection itself rather than the vaccine.
The agency added: "For the isolated cases of other medical conditions reported, the available evidence does not suggest that the vaccine caused the condition and these may have been coincidental events.
"The balance of risks and benefits of Cervarix remains positive."
GSK's cervical cancer vaccine Cervarix was chosen last year by the government for its controversial national HPV immunisation programme.
All 12-13 year-old-girls in the UK will be vaccinated with the drug, which can prevent around 70% of cervical cancers by blocking the HPV that causes the majority of cases.
Several hundred thousand doses of Cervarix have already been given to girls and the report was compiled following evidence submitted voluntarily by health professionals and members of the public.
The MHRA said reported events such as fainting and panic attacks can occur with any injection procedure, not just vaccination, and are thought to be down to fear and anticipation of the needle injection rather than being actual side-effects.
These events are particularly common in adolescents, and can be associated with a range of temporary symptoms including loss of consciousness and vision disturbance.
Isolated medical events, such as Guillain Barre Syndrome (GBS), are thought to have been coincidental, possibly caused by a preceding infectious illness.
There was no evidence that the vaccine has increased the frequency of GBS above that expected to occur naturally in the population.
Last September Cervarix was joint winner of the prestigious UK Prix Galien, which is awarded biannually to innovative drugs that represent the greatest advances in patient care.
It won with Sanofi-Pasteur MSD's Gardasil, Cervarix's rival in the HPV vaccine market.
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