In the event of an inadvertent temperature excursion the following data may be used:
A maximum cumulative time of 168 hours at temperatures above 8°C through to 25°C or 24 hours at temperatures above 8°C through to 37°C is permitted.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
Contact GSK in cases where the product has been exposed to temperature deviation other than described above. Refer to the current BNF for company contact details.
Gardasil 9 · Human papillomavirus (HPV ) diseases - prevention of cancers and diseases caused by HPV in women and men ages 27 to 45
Licence extension / variation
Merck Sharp & Dohme (MSD)
Merck & Co (name used in US for MSD)
Development and Regulatory status
Phase III Clinical Trials
Jan 21 · Nil on company pipeline/website.
Feb 19 · Nil in latest company annual report re: plans for expanding the licence for Gardasil 9 in any other countries to include women and men aged 27 to 45 years .
Oct 18 · Approved in US .
Jun 18 · Merck announced that the U.S. FDA has accepted for review a new supplemental Biologics License Application (sBLA) for Gardasil 9. The application is seeking approval for an expanded age indication for use in women and men ages 27 to 45. The FDA has granted Priority Review and has set a target action date of Oct 2018 .
A nine-valent human papillomavirus (HPV) L1 virus-like particle (VLP) vaccine
Lifetime risk of HPV infection exceeds 50% but most are asymptomatically infected
Human papillomavirus (HPV ) diseases - prevention of cancers and diseases caused by HPV in women and men ages 27 to 45
Trial or other data
Nov 18 · NCT03158220 completed .
Sep 17 · Initiation of an open-label PIII clinical trial (n=1200; EudraCT2015-005093-38; NCT03158220) to study the immunogenicity and tolerability of Gardasil 9 in women aged 27 to 45 years vs women aged 16 to 26 years. The trial aims to complete evaluation of a PIII trial (n>3800) of the quadrivalent vaccine, Gardasil, where the vaccine prevented 91% of cases of persistent infection, low-grade cervical abnormalities, pre-cancers, and external genital lesions caused by HPV vs placebo in women aged 24 to 45 years [2,3].