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Anti-cancer vaccine is approved

Published:Wednesday | March 10, 2010 | 12:00 AM
Eulalee Thompson

The anti-cervical cancer vaccine, Cervarix, was recently approved by the United States Food and Drug Administration (FDA) for use in girls and women 10 to 25 years old. The vaccine is currently being used here but is available only through private health practitioners as it is still not on the health ministry's national immunisation programme.

Dr Sharmaine Mitchell, obstetrician and gynaecologist and GlaxoSmithKline's designated local Cervarix expert, said that the FDA's approval in effect doesn't change the use of the vaccine here as it had already received European approval in 2005. She also indicated that the vaccine was already in use in other countries in the region.

GlaxoSmithKline (GSK), manufacturers of the vaccine, indicated, through a news release, that "countries all over the world have shown their interest in attaining a reduction of the incidence of this deadly disease (cervical cancer), although, so far, Panama is the only Latin American country that has taken the forefront by including this vaccine in its expanded immunisation programme, in order to prevent cervical cancer in every girl between the ages of 10 and 11 years".

Cervarix, according to GSK, also received pre-qualification from the World Health Organization that will enable developing countries to purchase it, through the United Nations, for inclusion in their national vaccination programmes.

Sexually transmitted germ

Cervical cancer is caused by a sexually transmitted germ, the human papilloma virus (HPV). Based on information from the Regional Core Health Data Initiative by the Pan American Health Organisation (2003), Jamaica's cervical cancer incidence (that is, new cases diagnosed annually) is 43.4 per 100,000 population. The incidence is 7.1 in Japan; 7.8 in the United States; eight in Canada; 23.8 in Cuba; 30.4 in Barbados; 33.3 in Trinidad and Tobago, and 93.9 in Haiti.

GSK stated that Cervarix offers strong, broad and long-lasting sustained protection against HPV types 16 and 18, responsible for more than 70 per cent of all cervical cancers in women in a greater age range. Data obtained from clinical studies conducted among women vaccinated with Cervarix have shown 100 per cent protection against the development of persistent infection and pre-cancerous lesions attributable to HPV types 16 and 18, included in the vaccine. Additionally, protection beyond those types has been proven, particularly against HPV 45 and 31, which, together with HPV 16 and HPV 18 account for about 80 per cent of all cervical cancers both in Latin America and all over the world.

Vaccine for girls and boys

Another anti-cervical cancer vaccine, Gardasil, by Merck & Co., Inc, has already been approved for vaccination in females nine to 26 years of age for the prevention of diseases caused by HPV types 6, 11, 16, and 18, and for vaccination in boys and men nine through 26 years of age for the prevention of genital warts caused by HPV types 6 and 11.

In the Cervarix vaccine approval documents posted on the FDA's website, the FDA estimated 11,270 new cases and 4,070 deaths from cervical cancer in the United States in 2009, based on information from the National Cancer Institute at the National Institutes of Health. The FDA also indicated that the primary clinical study for Cervarix included more than 18,000 women ages 15 years through 25 years in the United States and 11 other countries. Of these women, about 9,000 received Cervarix and 9,000 received Havrix, a licensed hepatitis A virus vaccine, as a control.

Regular Pap tests

"The licensure of Cervarix adds another option in the prevention of cervical cancer," said Karen Midthun, MD, acting director of the FDA's Center for Biologics Evaluation and Research. "It has the potential to save lives from cervical cancer as well as reduce the need for biopsies and invasive procedures associated with the necessary follow-up from abnormal Pap tests."

The current data, according to the FDA, show that Cervarix provides protection for about 6.4 years, but additional information on the length of protection is forthcoming. The FDA further advises that: "no vaccine is 100 per cent effective, and Cervarix does not protect against HPV infections that an individual may already have at the time of vaccination, nor does Cervarix necessarily protect against those HPV types not in the vaccine. Therefore, regular Pap tests continue to be recommended for all women who receive Cervarix. Pap screening remains critically important to detect pre-cancerous changes, which would allow treatment before cancer develops".

Cervarix is administered in three separate shots, with the initial dose being followed by two additional shots at one and six months.

Eulalee Thompson is health editor and a professional counsellor. Email: