ACSOV meeting statement, Meeting 7, 12 December 2014

Advisory Committee on the Safety of Vaccines

14 May 2015

Role of the Advisory Committee on the Safety of Vaccines (ACSOV) in the TGA's regulatory decision making process

The ACSOV is a statutory advisory committee established by the Therapeutic Goods Regulations 1990.

The TGA currently has nine statutory advisory committees from which it can obtain independent expert advice on specific scientific and technical matters to aid the TGA's regulatory decision making and other regulatory processes.

The ACSOV provides advice to the TGA and the Office of Health Protection (OHP) (Department of Health) on, amongst other things, matters relating to the safety, risk assessment and risk management of vaccines supplied in Australia.

How this statement should be read

The advice provided by the ACSOV is an important element in the undertaking of the regulatory functions of the TGA. However, it forms only one part of the total body of information that is available to, for instance, a TGA delegate making a regulatory decision under the Therapeutic Goods Act 1989 ('the Act'). Therefore, while appropriate consideration will be given to such advice, it is important to note that neither the TGA nor a TGA delegate is obliged to follow it.

It should also be noted that details of the committee's advice may not become publicly available for some time after the committee has provided that advice. The purpose of this Meeting Statement is to describe in general terms the matters considered by the committee at each meeting and for it to be available as soon as reasonably practical after the relevant meeting.

Additionally, following publication of this statement, it is most likely that further work will be undertaken by the TGA to investigate, monitor and/or evaluate the vaccines considered by the ACSOV; and this will continue for some time into the future. It is therefore possible that further information about the vaccines will become publicly available at a later time and this will be pursuant to a regulatory decision under the Act being made and following further consultation with the vaccine's sponsor and/or manufacturer.

Overview of the safety reviews and therapeutic goods referred for advice

The TGA continually monitors therapeutic goods supplied in Australia to ensure their ongoing safety, efficacy and quality. As part of this process, the TGA routinely undertakes safety reviews of therapeutic goods.

At this meeting, the committee's advice was sought on the following safety review.

Gardasil and premature ovarian insufficiency

At its third meeting in October 2013, ACSOV considered the issue of premature ovarian failure, a condition now termed premature ovarian insufficiency (POI), following Gardasil vaccination. In summary, the ACSOV advice at that time was that:

  • there was no biologically or epidemiologically plausible explanation for POI following Gardasil vaccination;
  • there was no signal for premature ovarian insufficiency following the use of Gardasil; and
  • there would be value in seeking the opinion of a recognised gynaecological expert on the conclusions in the TGA safety filter.

As part of its further consideration of the issue at this meeting, ACSOV reviewed a report from a recognised gynaecological expert, which was commissioned by the TGA to provide advice on any possible association between Gardasil and POI.

ACSOV was asked to provide comment on whether the updated information and the advice received from the gynaecological expert changed the Committee's previous advice as outlined above. Following its consideration and discussion of the latest information, ACSOV provided the following conclusions -

  • The committee confirmed its previous advice that there was no biologically plausible explanation for POI following Gardasil vaccination and there was no signal of a causal association for POI following administration of the vaccine;
  • The committee advised that while the epidemiological data were limited, at this time it did not support an association linking POI and Gardasil. The committee advised that current monitoring activities should continue.

The committee also suggested direct communication by the TGA with the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) regarding POI in the community and the development of a case definition that could be applied if further investigation was needed, perhaps in conjunction with the Brighton Collaboration.

Risk Management Plans (RMP)

A Risk Management Plan (RMP) is a set of pharmacovigilance activities and interventions designed to identify, characterise and manage risks relating to a medicine or a vaccine. At this meeting, the committee's advice was sought on RMPs for two vaccines. One related to an application to register a new vaccine while the other related to the addition of details about clinical trials in specified high risk patient groups to the Product Information document for a currently registered vaccine.

In broad terms, the committee was asked to provide advice regarding the adequacy of the RMPs to monitor, and mitigate the risks for the vaccines. The committee provided specific advice on the need to conduct additional pharmacovigilance activities, the need for additional risk minimisation activities (namely the provision of educational materials), the completeness of the list of safety concerns and the adequacy of the pharmacovigilance and risk minimisation measures outlined in the RMP in managing the safety risks related to co-administration of one of the vaccines and the use of antipyretic agents.

The committee's advice has now been provided to TGA delegates for consideration as part of the TGA's regulatory decision making processes.

Following complete assessment of the application, information on the RMP evaluations will be included in the Australian Public Assessment Reports (AusPAR), which is published on the TGA website once it is finalised.

Other matters considered

The committee was advised that the Department of Health ("the Department"), on behalf of the Australian Technical Advisory Group on Immunisation (ATAGI), was undertaking a public consultation on draft updates to five chapters of the Australian Immunisation Handbook 10th edition where there was updated clinical advice.

Pending submission to the National Health and Medical Research Council (NHMRC) in June 2015 for approval, these updates to clinical advice will be included in the July 2015 annual online update of The Australian Immunisation Handbook. Members, and interested colleagues, were asked to provide comments by 16 January 2015.

The committee noted the final reports of three projects on enhanced surveillance of adverse events following immunisation (AEFI) - the AusVaxSafety Project, the PAEDS measles vaccine AEFI project and the AEFI Clinical Assessment Network (AEFI-CAN) Human Papillomavirus (HPV) Pilot project, and no vaccine safety signal was identified.

The committee noted the intention to extend the seasonal influenza program to include Aboriginal and/or Torres Strait Islander children aged six months to less than five years and the proposed enhanced AEFI monitoring activities for seasonal influenza vaccines for the 2015 influenza season.

The committee was advised that pending financial approvals, the AusVaxSafety Project for 2015 would be extended to include additional sites in Queensland, Western Australia and the Northern Territory, to provide coverage of the extended population of Aboriginal and/or Torres Strait Islander children aged six months to less than five years.

The committee noted the proposed Commonwealth communications activities for the 2015 influenza season, which will include posters, direct letters from the Chief Medical Officer to key stakeholders, and social media.

The committee also noted the status of vaccine safety activities undertaken by the Department as a result of the implementation of the Review of the management of adverse events associated with Panvax and Fluvax (the 'Horvath Review')1. Some activities introduced through the Horvath Recommendations had now become business-as-usual.

Further information

Meeting statements are made publicly available after each meeting.

For further information on the ACSOV, please visit the ACSOV webpage or contact the ACSOV Secretary: Mr Craig Davies on 02 6232 8641 (telephone) or via email: acsov@tga.gov.au.


Footnote

  1. Review of the management of adverse events associated with Panvax and Fluvax