Major shift recommended in use of HPV vaccines for cervical cancer prevention

Pharma News: Human papillomavirus (HPV) vaccination of young adolescents with 2- and 3-dose schedules of GSK’s Cervarix and MSD’s Gardasil (distributed by Seqirus Australia) has been the recommended standard of care for several years in Australia and other countries.

According to a recent landmark study, cervical cancer rates are 87% lower in women who were offered HPV vaccination when they were between the ages of 12-13 than in previous generations.

Due to recent international changes, a major shift from 2- and 3-dose schedules to a single dose vaccine schedule will be implemented for the Australian population.

The Pharmaceutical Benefits Advisory Committee (PBAC), in its December 2022 meeting outcomes, recommended that the National Immunisation Program (NIP) listing of Gardasil vaccine be changed from 2 doses to 1 dose for the adolescent vaccination program and that the upper age limit for catch up vaccination be updated from 20 years to 25 years.

The PBAC noted the advice of the Australian Technical Advisory Group on Immunisation (ATAGI) regarding the likely non-inferior efficacy of a single dose of Gardasil vaccine compared to 2 doses in immunocompetent adolescents aligned with recommendations made by the World Health Organisation (WHO) Strategic Advisory Group of Experts on Immunisation and the UK’s Joint Committee on Vaccination and Immunisation.

The ATAGI recommended that adolescents and adults aged up to 25 years who did not receive HPV vaccination during adolescence be eligible to receive a single dose of Gardasil vaccine (previously up to age 19 years).

The clinical impacts of not proceeding with the schedule change would mean people aged 20 to 25 years, who did not receive a funded HPV vaccine during adolescence, will not be eligible for a funded vaccine.

The PBAC said it noted the resistance from MSD and Seqirus Australia with regards to implementing the proposed change, citing data immaturity and that a hasty move may jeopardise Australia’s long-term plans to eliminate HPV.

However, the PBAC said it considered the ATAGI advice and available evidence carefully and was “reassured by the long-term immunogenicity studies of single versus multiple doses which demonstrated stabilised geometric mean concentrations out to 11 years.”

It is likely that a similar change will be applied to GSK’s Cervarix vaccine.

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