TGA Provisional Approval of Moderna COVID-19 vaccine to include 12-17 years age group
On September 4 2021, the Therapeutic Goods Administration (TGA) granted provisional approval to Moderna Australia Pty Ltd for its COVID-19 vaccine—Spikevax (elasomeran) to include the 12-17 years age group. This decision follows the provisional approval granted by the TGA to Spikevax on 9 August 2021 for use in individuals aged 18 years and older.
To find out more information, please refer to our dedicated MVEC Moderna COVID-19 vaccination page in the link below:
MVEC Moderna COVID-19 vaccination page
New immunisation reference page: Immune thrombocytopenia (ITP)
Immune thrombocytopenia, also previously known as idiopathic thrombocytopenia purpura (ITP), is an uncommon autoimmune condition in which the body’s own immune system attacks platelets (the cells found in the blood which normally help the blood to clot).
Our new reference page discusses the background of ITP, including presentation of the condition and the association between ITP and MMR vaccines. Our page also answers questions around ITP and COVID-19 vaccines, including whether or not COVID-19 vaccines should be administered to people with a history of ITP.
To read more follow the link below:
MVEC: Immune thrombocytopenia (ITP)
MVEC animation: Myocarditis, pericarditis and COVID-19 vaccines
MVEC have created a new animation to help explain myocarditis and pericarditis which have been reported in a small number of individuals who have received mRNA COVID-19 vaccines Comirnaty™ and Moderna.
To view the animation and to find out more information, please refer to our myocarditis, pericarditis following COVID-19 mRNA vaccines immunisation reference page:
MVEC animation: Myocarditis and pericarditis following COVID-19 mRNA vaccines
COVID-19 vaccine FAQs: women's health
We have expanded our COVID-19 vaccine FAQs to include a section specific to women's health.
To view commonly asked questions on COVID vaccines and planning pregnancy, pregnancy, breast-feeding and menstruation please please follow the link below:
MVEC: COVID-19 vaccine FAQs: women's health
Updated immunisation reference page: Needle phobia
We have recently updated our Needle phobia page to include the latest information and resources available for addressing needle phobia.
Our page includes information and strategies for health care providers, individuals and care givers to manage needle phobia and immunisation.
To view this page, please click on the following link:
SAEFVIC Rapid report: a new reporting pathway for COVID-19 vaccine AEFI
Reporting adverse events following immunisation (AEFI) is not mandatory in Victoria, however doing so allows the rapid investigation of any potential vaccine or system problems. This helps to ensure a safe and effective immunisation program and it maintains community confidence in vaccines.
The new SAEFVIC Rapid reporting pathway has been launched for reporting any common or expected side effects following a COVID-19 vaccine. Reporting via this pathway will not result in follow up of clinical symptoms however it will contribute to data collection and assist health authorities to understand the frequency of symptoms occurring. Should the vaccinee experience significant side effects, completing the SAEFVIC Extended report is recommended.
For more information on SAEFVIC, symptoms that should be reported, and instructions on how to report, please visit our immunisation reference page below:
MVEC: Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC)
Updated immunisation reference page: Vaccine confidence
We have recently updated our Vaccine confidence immunisation reference page to include the latest information and resources available to help address people’s questions and concerns about vaccines.
Our page includes information on how to talk to people who have concerns about vaccines, how to tackle misinformation and how to be a vaccine champion in your workplace or community.
To view this page, please click on the following link:
New immunisation reference page: Myocarditis and pericarditis following mRNA COVID-19 vaccines
Myocarditis is an inflammatory disease of the heart muscle, whilst pericarditis is an inflammatory disease of the lining of the heart muscle. They are rare conditions, most commonly associated with viral infections (including SARS-CoV-2) but can also be triggered by other factors such as medications and autoimmune conditions. Globally, an increased number of cases above an expected population rate of myocarditis and pericarditis have been reported in individuals who have received mRNA COVID-19 vaccines (eg. Comirnaty™ and Moderna).
Our new reference page discusses the temporal association of myocarditis and pericarditis with mRNA COVID-19 vaccination, symptoms, investigations, as well as the implications on future COVID-19 vaccination.
To read more follow the link below:
MVEC: Myocarditis and pericarditis following mRNA COVID-19 vaccines
New immunisation reference page: Moderna COVID-19 vaccine
Following the announcement by the Australian Government that 25 million doses (as well as additional variant specific versions) of Moderna's COVID-19 vaccine, Elasomeran, had been secured for the Australian population, this vaccine was last week granted provisional determination by the TGA.
Our new reference page explores the various clinical trials involving Elasomeran, as well as details the immunogenicity, efficacy and safety data available for this vaccine.
To read more follow the link below:
MVEC: Moderna COVID-19 vaccine
New immunisation reference page: COVID-19 mixed vaccine schedules
With the emergence of variant COVID-19 strains, global vaccine supply issues, and the need to rapidly immunise the population, a number of clinical trials are investigating the option of “mixed schedules”. Mixed schedules have been used previously in other vaccination strategies and involve the administration of different vaccine brands to complete a vaccine course.
Our new reference page explores the clinical trials underway which aim to determine the safety of mixed scheduling, the immunogenicity, as well as the recommendations for intervals between doses.
Due to a lack of available data, mixed vaccine schedules are not currently approved in Australia however are in use in Canada and across Europe.
To read more, follow the link below:
MVEC: COVID-19 mixed vaccine schedules