Human papillomavirus vaccine

ArticlesRefrigerated StorageLactation Safety InformationNew Medicines ·
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Articles

Refrigerated Storage

GardasilMerck Sharp & Dohme Limited

Merck Sharp & Dohme Limited
Gardasil
Suspension for injection

In the event of an inadvertent temperature excursion the following data may be used:

Data from stability studies demonstrate that the vaccine components are stable for 72 hours when stored at temperatures from 8°C to 42°C. At the end of this period Gardasil should be used or discarded.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

Yes- reduce to 72 hours from the date of temperature excursion.
Not stated by manufacturer
15 May 2020
London MI Service

CervarixGSK

GSK
Cervarix
Suspension for injection in pre-filled syringe

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.

No, if exposed to conditions described above
Yes, if exposed to conditions described above
18 December 2019
London Medicines Information Service

Lactation Safety Information

Recombinant vaccines containing components from either two (bivalent) or four (quadrivalent) HPV types
16 September 2020

New Medicines

Gardasil 9 Human papillomavirus (HPV ) diseases - prevention of cancers and diseases caused by HPV in women and men ages 27 to 45

Information

Gardasil 9
Licence extension / variation
Merck Sharp & Dohme (MSD)
Merck & Co (name used in US for MSD)

Development and Regulatory status

None
Phase III Clinical Trials
Launched
Jan 21Nil on company pipeline/website.[7]
Feb 19Nil 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 [6].
Oct 18Approved in US [4].
Jun 18Merck 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 [1].

Category

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
Intramuscular

Trial or other data

Nov 18NCT03158220 completed [4].
Sep 17Initiation 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].