Safety in Lactation: Vaccines and antisera

21 September 2020Although vaccines and toxoids (diphtheria and tetanus) are considered to be compatible with breastfeeding, their use should be limited to those situations where there is…
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Refrigerated Storage

GardasilMerck Sharp & Dohme Limited

Merck Sharp & Dohme Limited
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.

Please also refer to the manufacturer’s product literature for recommended storage information at

Public Health England has guidance on responding to errors in vaccine storage, handling and administration.

15 May 2020
London MI 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


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

Development and Regulatory status

Phase III Clinical Trials
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].


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 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].