Vaccine Comes One Step Closer
Moderna’s COVID vaccine, set for pharmacy supply, wins provisional TGA approval
The Therapeutic Goods Administration has granted provisional approval to Elasomeran, Moderna’s COVID vaccine that is slated for provision through community pharmacy.
In an announcement issued late on Thursday 24 June, the TGA said: “This mRNA vaccine will be considered for the active immunisation to prevent coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2, in individuals aged 12 years of age and older.
While the vaccine has approval or emergency use authorisation in a number of other countries for older populations, it is currently under review in some of those countries for adolescent populations”.
If approved, a complete course of the Moderna vaccine is likely to be two doses given 28 days apart, the TGA said.
Federal Health Minister Greg Hunt said last week that the Moderna vaccine would most likely be supplied through community pharmacies in Stage 3 of the vaccine rollout.
“It’s most likely that the pharmacies will do Moderna…. that’s the initial planning at this stage,” he said, responding to media questions.
The granting of a provisional determination means that the TGA has made a decision that Moderna is now eligible to apply for provisional registration for the vaccine in the Australian Register of Therapeutic Goods (ARTG).
“Provisional determination is the first step in the process. It is anticipated that Moderna will submit an application for provisional registration shortly. Importantly, registration and supply in Australia will only commence should the vaccine be approved as safe and effective by the TGA”.
The federal government has secured 25 million doses of the Moderna COVID-19 vaccine to “further diversify Australia’s vaccine portfolio as well as provide access to a booster or variant vaccine should this be required in the future,” the announcement said.
The agreement includes the supply of 10 million doses in 2021 and of 15 million doses of Moderna’s updated variant booster vaccine in 2022.
Source: https://ajp.com.au/news/vaccine-comes-one-step-closer/ , viewed 29 June 2021.