Medicines Australia welcomes TGA approval of Moderna vaccine

Pharma News: Medicines Australia welcomes the TGA provisional approval for the COVID-19 vaccine, SPIKEVAX (elasomeran) for Australia. Moderna’s mRNA-based vaccine is expected to arrive in Australia this month.

The TGA announced provisional approval for the Moderna vaccine in August and on Saturday, also provided provisional approval to include Australians between the ages of 12-17 years old. The Pfizer and Moderna COVID-19 vaccines will both be made available to adolescents and be an important tool for Australia’s social and economic recovery.

“The more people in Australia that get vaccinated, the more chance there is of eradicating the national COVID-19 pandemic,” said Elizabeth de Somer, CEO of Medicines Australia.

“When you get vaccinated you are not just protecting yourself. You are also reducing the risk of passing on COVID-19 to your family, friends and community. I am grateful to have received both of my vaccine shots and to do my bit to fight against COVID-19.”

Paul Griffin, Director of Infectious Diseases at Mater Health Services, Associate Professor of Medicine at the University of Queensland, and Medical Director and Principal Investigator at Q-Pharm, Nucleus Network, stated “It is indeed welcome news to hear of the approval of yet another safe and effective vaccine for COVID-19 in this country.

“While our rollout has faced many challenges, it is clear that supply has been one of the most significant constraints and to have an additional vaccine as an option reduces our reliance on existing supply chains that have not been able to meet demand thus far (keeping in mind of course that the AstraZeneca vaccine is manufactured in Australia so not in limited supply).

“The Moderna vaccine has demonstrated high levels of efficacy in large clinical trials that have been verified by data arising from extensive real-world experience. Whilst similar to Pfizer in terms of mechanism of action, safety, efficacy and effectiveness, subtle differences include that the interval is 4 weeks between doses for Moderna as opposed to 3 typically with Pfizer and it does appear Moderna has slightly more temperature stability data so is a little easier to transport and store, including for example being able to be stored at fridge temperature for 30 days and room temperature for 12 hours,” he added.

In addition to the years of research behind vaccine technology, speed has been achieved due to a large injection of funding from pharmaceutical companies as well as running development and implementation phases side-by-side, instead of one after the other.

Medicines Australia will continue to work closely with all their partners across healthcare to ensure all Australians have access to COVID-19 vaccines.