09 August, 2021 – Moderna mRNA COVID-19 Vaccine Approved
The Therapeutic Goods Administration (TGA) has provisionally approved Moderna’s mRNA vaccine for use in Australia, in record time. Australia’s fourth approved vaccine, one million doses are due to be released in the second half of September, 2021.
The Spikevax (elasomeran) vaccine is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for active immunisation to prevent coronavirus disease-2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age and older. It is recommended that the vaccine is given in two doses that are administered 28 days apart.
Therapeutic Goods Administration (TGA) Australia
The vaccine has been rolled out widely in the US, where more than 140 million doses have been administered since it was granted emergency approval last December. Britain has purchased 17 million doses, which it began rolling out in April.
Record Setting TGA ACCESS Consortium Track
The vaccine was approved in just 23 days via the TGA’s ACCESS Consortium track due to a heroic effort by the TGA, Moderna and their Australian regulatory partner, Adjutor Healthcare.
The process officially kicked off in June with the SPIKEVAX (elasomeran) COVID-19 vaccine being given a provisional designation, however by then work was already well underway, gathering the data required by the TGA, to assess what is now, Australia’s second provisionally approved mRNA vaccine.
Adjutor Healthcare’s CEO Dr Rosalie Cull said Moderna had received regulatory approval or emergency authorisation in the four other ACCESS Consortium countries – the UK, Canada, Switzerland and Singapore.
“Provisional evaluation reports from the other agencies were already available and so we didn’t have to answer the same questions all over again which made it easier. Regardless, the data package was submitted and TGA did a very thorough job in their review.“
“The speed of the assessment and the workload put the process “on another planet” when compared to normal regulatory work from all sides – the TGA, Adjutor and Moderna.“
With Moderna’s International Head of Regulatory Affairs based in Europe, Moderna headquartered in the US and Adjutor and the TGA in Australia, the time differences were used to Adjutor’s advantage.
“We were able to leverage our regulatory team in New Zealand. If we had a call with Europe at the end of the day, we were able to action things with the US overnight and were getting the responses to the TGA the next morning.”
“None of us usually want to work that intensely – that’s not the normal way of working but in a pandemic, we all do what we can. We put our own lives aside, working around the clock at times, and just do what needs to be done.”
It wasn’t just the speed of the application that was different but also the way that Adjutor worked with the regulator.
“The fundamentals of any application are going to be the same – you need your quality, safety and efficacy data, your Module 1, your PI negotiations and your GMP clearances – all of those things are the same. But the way we worked with the TGA was very different.”
“Everyone was laser-focused on getting this through as soon as humanly possible without compromising on principles of quality, safety and efficacy. How do you do that? Work long hours and weekends and have lots of meetings. The communication with the TGA was amazing.”
“Why did we do it? Because it’s not just about healthcare, it’s also about families being reunited, community, businesses staying afloat, and the economy. We all recognise and relate to that. It’s a real privilege to be part of and definitely a career highlight for me.”
Moderna’s partnership with Adjutor Healthcare has taken the Melbourne based company, founded by Dr Cull, from guiding Project Orbis and PPE applications through the TGA last year to managing one of the most important regulatory assessments in the TGA’s extensive history.
Adjutor Healthcare’s COO Deb Cooper said recently –
“How often do you get to work on a product that is relevant to so many people, including ourselves?”
“We do a lot of work with orphan drugs that are life-changing for a very small percentage of the population, but this is important for everybody, for the whole country. That was a big motivator for us.”
Australia has pre-purchased 25 million doses of Spikevax, with 10 million doses due to be delivered in 2021 and 15 million doses of the updated variant booster vaccine in 2022. The vaccine is still under assessment for the 12-17 age group, with an outcome expected in the coming weeks.
Further reading:
https://www.tga.gov.au/media-release/tga-provisionally-approves-modernas-covid-19-vaccine
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