CHMP recommends Sanofi’s two-dose schedule HPV vaccine
pharmafile | March 3, 2016 | News story | Research and Development | HPV vaccine, MSD, Sanofi Pasteur
Sanofi Pasteur’s and MSD’s vaccine against human papillomavirus (HPV), Gardasil 9, has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP).
The Committee recommended a two-dose schedule in boys and girls aged nine to 14 for the vaccine, which is marketed in western European countries by Sanofi, and by MSD in other countries including the US and eastern European nations.
HPV is a DNA virus that can lead to many forms of cancer. This vaccine is indicated for active immunisation of individuals from the age of nine years against cervical, vulvar, vaginal and anal cancers causally related to vaccine HPV types and genital warts causally related to specific HPV types.
Gardasil 9 – named for the protection it offers against nine forms of HPV – was originally approved by the EU in June 2015 with a three-dose schedule for all age groups. This new variation to a two-dose schedule is based on the results of a clinical trial performed in about 1,200 girls and boys aged nine to 14 years old and 300 young women 16 to 26 years old, the latter being the age group in which the efficacy of the vaccine was demonstrated.
It was found in the trial that the vaccine-type anti-HPV immune response following vaccine administration in the 9-14 age group was non-inferior to that seen in the young women aged 16-26, who received three doses over a similar time period.
The CHMP’s positive indication of the two-dose schedule will now be reviewed by the European Commission for final approval.
Dr Ned Powell, leader of HPV research at Cardiff University Medical School, comments: “Approval of a two-dose schedule for 9-valeant HPV vaccine is great news, both for young women and for the NHS, and will increase the number of young women who are protected against a range of HPV-associated diseases. Use of a two dose schedule for HPV vaccines has already reduced the cost of delivering the vaccination programme and minimised the inconvenience of vaccination.”
All girls aged between 11 and 14 in the UK are offered the Gardasil HPV vaccine. Figures from Public Health England have shown that eight million doses have been given in the UK, with close to 90% of eligible girls vaccinated. While there is no immunisation programme offered to boys of the same age, there have been concerted efforts to change that. As John Ashton, president of the Faculty of Public Health, told the Guardian: “All boys should also receive this vaccine: we believe it cannot be right to withhold an effective health intervention from a section of the population simply on the grounds of sex.”
Sean Murray
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