Aus teens now eligible for Pfizer, TGA approves antibody treatment

By Lauren Davis
Monday, 30 August, 2021

Aus teens now eligible for Pfizer, TGA approves antibody treatment

The Australian Technical Advisory Group on Immunisation (ATAGI) has recommended Pfizer’s COVID-19 vaccine, Comirnaty, for all adolescents 12 years of age and above, following a review of the medical evidence.

The Therapeutic Goods Administration (TGA) originally announced provisional approval of the use of the Pfizer vaccine in individuals 12 years and older in late July. In early August, ATAGI recommended the vaccine for teens at a higher risk of severe illness if they contract COVID-19, including those with underlying medical conditions, who identify as Aboriginal and Torres Strait Islander or who live in a remote community. Now this recommendation is being extended to all individuals from 12 years of age, while acknowledging that the severity of COVID-19 is less in adolescents compared with adults.

“Vaccinating young people will protect them and provide peace of mind to their family,” Prime Minster Scott Morrison said.

“Importantly, this decision provides the opportunity for families to come together to visit their GP and get vaccinated.”

Coordinator General of Operation COVID Shield Lieutenant General John Frewen has been working with the Commonwealth and states and territories on coordinating an approach for this age group while supporting those jurisdictions wishing to undertake a school-based vaccination later in the year. This detail will be outlined by each state and territory.

It is expected that all children 12–18 years of age will have access to a vaccine during the course of 2021, with the age group between 12 and 15 comprising approximately 1.2 million children. Minister for Education and Youth Alan Tudge said the rollout of the vaccines to younger Australians should give more confidence to jurisdictions to keep schools open and community activity alive.

“Keeping kids in schools is so important, not just for their education, but for their mental health, physical development and to have those critical interactions with their peers and teachers,” he said.

Parents should check the COVID-19 eligibility checker from 13 September to book in their child’s vaccination. Bookings will be available through GPs, Commonwealth Vaccination Clinics and Aboriginal Community Controlled Health Organisations. Each state and territory will advise when their state vaccination clinics will open to this group.

The TGA is also currently considering the use of the Moderna vaccine in 12–17 years of age as a priority, with a decision expected soon. Pharmacies will come on board to administer Moderna subject to approval by the TGA and ATAGI.

Meanwhile, Australians with COVID-19 who are at risk of hospitalisation will now have access to an additional treatment, as the TGA has granted provisional approval for the novel monoclonal antibody treatment known as sotrovimab to be used in Australia.

The sotrovimab treatment requires a single dose to be administered through an intravenous (IV) infusion in a healthcare facility and has been shown to reduce hospitalisation or death by 79% in adults with mild to moderate COVID-19 who are at risk of developing severe COVID-19. It is expected that sotrovimab will be targeted for the treatment of Australians over 55 years old who have COVID-19 and also have one or more of the following risk factors for disease progression: diabetes, obesity, chronic kidney disease, heart failure, lung disease and moderate to severe asthma.

Medical experts estimate that 8–15% of adults with COVID-19 will be recommended for treatment with sotrovimab, which must be given within five days of symptoms onset. The TGA has given approval to GlaxoSmithKline (GSK) Australia to make sotrovimab available for COVID-19 patients in Australia, to be made free of charge through the public health system.

Sotrovimab is approved for emergency use in the US, Singapore and Canada; however, Australia is the first OECD country to issue a formal regulatory approval for sotrovimab. The Australian Government’s purchase of sotrovimab has been supported by the Science and Industry Technical Advisory Group (SITAG), which is the government’s expert group advising on COVID-19 vaccine and treatment purchases.

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