- 3 years ago
16 June 2021
A local company that specialises in regulatory submissions has been named by global vaccine giant Moderna to guide its mRNA vaccine through regulatory processes, saying it is the type of project they live for.
Adjutor Healthcare will manage the regulatory submission and approval process of Moderna’s mRNA vaccine through TGA processing, as well as providing post-approval regulatory maintenance and other commercialisation services.
Led by industry stalwart Dr Rosalie Cull, the company has offices in Melbourne and Auckland and announced it had entered into an agreement for the provision of regulatory and other services to Moderna for its Australian operations.
“This is something wonderful for Australia and for our team to be involved with,” Dr Cull said.
“A project like this is what we live for. We’re very proud to have been chosen by Moderna as their Australian support team for regulatory and commercialisation services and we look forward to a long and successful relationship.”
Moderna announced on 12 May it had inked a new supply agreement with the Australian Government for 25 million doses of its COVID-19 mRNA vaccine. More recently, it announced plans to open a commercial subsidiary in Australia this year.
Health Minister Greg Hunt says the Moderna vaccine will predominantly be relied upon for booster doses in the ongoing battle against Covid, which is expected to remain an ongoing health challenge.
The first one million doses of the Moderna vaccine will arrive in September and another nine million in December. The remaining 15 million doses will be of its next-gen booster vaccine and be delivered in 2022.
Novavax trial data ‘very impressive’
It comes as Novavax announced its vaccine was more than 90 per cent effective in preventing people from falling ill from COVID-19.
Australia’s third vaccine option and expected to arrive in the third quarter of 2021, Novavax announced the results of its phase 3 trials involving nearly 30,000 participants in the US and Mexico, with only 14 vaccinated trial participants contracted Covid. The most common side effects were fatigue, headache, muscle aches and pain at the injection site which lasted no more than two or three days.
“It’s really very impressive,” Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told The Washington Post. “It’s very important for the world’s population to have, yet again, another highly efficacious vaccine that looks in its trial to have a good safety profile.”
Novavax plans to seek approval with regulators by the end of September and be able to produce up to 100 million doses a month by then. It is being guided through Australian regulatory processes by Sydney-based Biocelect.