The vaccine manufacturer Moderna is considering Australia as part of a clinical trial to test its Covid-19 vaccine in children.
In its latest quarterly report filed in the United States to the federal financial regulatory agency, Moderna indicated it would test the safety and efficacy of its Covid vaccine in 6,000 healthy children aged between six months and 12 years.
The pharmaceutical company reported it would enrol participants “in the US and up to two ex-US countries (eg. Canada and/or Australia)”.
The trial, which is planned to run until mid-2023, is staggering recruitment across three age groups: first in children aged between six and 12, then children aged between two and six, and finally babies between six months and two years old.
The study will test the Covid vaccine’s safety as well as reactogenicity – its tendency to produce common adverse effects, such as fever or a sore arm.
The report to the US Securities and Exchange Commission comes as the Australian government announced on Sunday the Moderna vaccine would become available in Australia from mid-September.
Greg Hunt, the federal health minister, said Australia’s Therapeutic Goods Administration was likely to approve the Moderna vaccine for use in the coming fortnight, with one million doses of the vaccine available in the middle of September.
In total, 10 million Moderna vaccine doses are expected to be delivered this year, with an additional 15m booster doses secured for 2022.
The vaccine has been approved for use in many jurisdictions internationally, including the US, the European Union and Singapore.
The Moderna vaccine is likely to be administered as two doses given 28 days apart. Like the Covid jab manufactured by Pfizer, it is an mRNA vaccine: it uses a segment of genetic code that triggers the production of the coronavirus’s spike protein in the body, which immune cells then mount a response against.
In the US, Pfizer has also commenced clinical trials of its Covid-19 vaccine in children aged between six months and 12 years.
