Therapeutic Goods Administration Grants Preliminary Approval for…

Therapeutic Goods Administration Grants Preliminary Approval for…


The announcement follows recent approvals of the company’s mRNA-COVID-19 vaccine in Argentina, Canada, Israel, the United States and Taiwan for active immunization to prevent COVID-19, caused by SARS-CoV-2, in children Age from 6 months to five years

CAMBRIDGE, MA / ACCESSWIRE / July 18, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced today that the Therapeutic Goods Administration (TGA) in Australia has granted preliminary registration for use of the mRNA COVID-19 vaccine from Moderna. Spikevax, in a two-dose series of 25 mcg per dose, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 months to 5 years. So far, children under the age of six have been the only age group ineligible for vaccination against COVID-19 in Australia.

“We are pleased that our vaccine for children under the age of six has received provisional approval from the TGA,” said Michael Azrak, Moderna’s general manager for Australia and New Zealand. “The continued evolution of COVID-19 poses a new threat to global public health, including young children. Since the beginning of the pandemic, we have worked with great responsibility to deliver on the promise of mRNA science to all Australians. The TGA’s approval helps empower all parents and carers in Australia to protect their young children from SARS-COV-2.”

Positive interim results from phase 2/3 KidCOVE study, announced on March 23, 2022, demonstrated a robust neutralizing antibody response in the 6 month to 5 year age group following a two-dose primary series of mRNA-1273, along with a favorable safety profile. Antibody titers in the pre-specified subgroups of ages 6 months to 23 months and 2 years to 5 years met statistical criteria for similarity to adults in the COVE study, which met the primary objective of the study. Preliminary efficacy analysis of pooled PCR-confirmed cases…


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