Drug Safe, Long Term Effects Unknown
The national adviser for Family Health Doctor Josaia Samuela said Gardasil has already gone through the clinical tests and it has been proven that the vaccine prevents infection from HPV.
He said HPV can cause cervical cancer and parents of the girls between the ages of 9 and 12 years should give their consent to have their daughters vaccinated as it will assist in the prevention of cancer of the cervix.
However, Doctor Samuela admitted that the vaccine Gardasil is still new and its long term effects are still unknown.
So how did Fiji get the vaccine which is classified as very expensive, costing about NZ$600 a vial?
Fijivillage has received confirmation that the vaccine Gardasil was received by Fiji as a donation due to its short term shelf life from the drug company Merck.
Merck has given Fiji a total of 111,000 vaccines valued at US$13.9 million.
According to the Food and Drug Administration in the US which approved Gardasil, it said in a letter dated June 8th, 2006, to Merck that the dating period for Gardasil shall be 36 months from the date of manufacture and the post marketing studies are subject to reporting requirements.
The final study protocol was to be submitted by December 31st, 2006, patient accrual completed by December 2008, the study to be completed by June 30th, 2009, with the final study report to be submitted by September 30th next year.
Although Doctor Samuela stressed that the clinical tests are complete and based on that they have taken advantage of the free vaccine provided by Merck, he does admit that Gardasil is still in its post marketing surveillance period and some drugs have been taken off the shelves during this period.
Fijivillage asked Doctor Samuela why the Health Ministry pamphlet, which is being distributed to parents for their consent for their daughters to be vaccinated, does not have the information that Gardasil is in its post marketing surveillance.
He said it will only confuse parents and they may not allow their daughters to be vaccinated.
Doctor Samuela said 26 million girls around the world have already been vaccinated and Gardasil is safe as it has been approved by health regulators in the US, the UK, Australia and NZ.
In Fiji, so far 2,600 girls between the ages of 9 and 12 years have been vaccinated in Suva, 95 percent of the girls in the age bracket have been vaccinated in the Eastern Division and 83 percent of the targeted girls have been vaccinated in Macuata.
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