TGA starts review of Moderna's Spikevax for full registration

The Australian Therapeutic Goods Administration (TGA) said today that it has commenced evaluation of an application from the local subsidiary of US mRNA vaccines specialist Moderna (Nasdaq: MRNA) to transition its Spikevax (COVID-19 Vaccine, mRNA), to full registration for the immuniz0ation of individuals six years and over, and as a booster dose for individuals aged 12 years and older.

This is the first application received by the TGA to transition a provisionally-approved COVID-19 vaccine to full registration. However, a number of COVID-19 vaccines, including Spikevax already have the equivalent of full registration (market authorization) in major overseas countries, including in the all-important US market, where Spikevax clearance emergency use was changed to full approval by the Food and Drug Administration in February last year.

Currently in Australia this mRNA vaccine is provisionally approved for immunization to prevent COVID-19 in individuals aged 6 months and older, and as a booster dose for individuals aged 12 years and older.