Policy & Regulation
Moderna Inks New Supply Agreement with Australia for 25m Doses of its COVID-19 Vaccine
12 May 2021 - - US-based biotechnology company Moderna, Inc. (NASDAQ: MRNA) has inked a new supply agreement with the government of Australia for 25m doses, the company said.

This includes 10m doses of Moderna's COVID-19 vaccine against the ancestral strain (mRNA-1273) to be delivered in 2021 and 15m doses of Moderna's updated variant booster vaccine candidate to be delivered in 2022.

Purchase under this agreement is subject to regulatory approval of mRNA-1273 and booster vaccine candidates by the Therapeutic Goods Administration of Australia.

The company expects to submit an application to the TGA shortly.

As Moderna has continued to scale its commercial network, the company announced earlier this year that it also plans to open a commercial subsidiary in Australia in 2021.

Initial data from Moderna's Phase 2 study in the US showed that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 and two variants of concern, B.1.351 (first identified in South Africa) and P.1 (first identified in Brazil).

A booster dose of mRNA-1273.351, the company's strain-matched booster, achieved higher neutralizing antibody titers against the B.1.351 variant of concern than a booster dose of mRNA-1273.

Safety and tolerability profiles following third dose booster injections of 50 µg of mRNA-1273 or mRNA-1273.351 were generally comparable to those observed after the second dose of mRNA-1273 in the previously reported Phase 2 and Phase 3 studies.

A manuscript describing these preliminary results was submitted as a preprint to medRxiv and will be submitted for peer-reviewed publication upon completion of the multivalent mRNA-1273.211 booster arm.

The COVID-19 Vaccine Moderna (referred to in the US as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases' (NIAID) Vaccine Research Center.

On December 18, 2020, the US FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older.

Moderna has also received authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar, Taiwan, the Philippines, Brunei and from the World Health Organization.

Additional authorizations are currently under review in other countries.
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