Connect with us

Hi, what are you looking for?

Australia/New Zealand

Nod for AstraZeneca’s tixagevimab, cilgavimab for Australians aged 12 and above

Australia TGA nod for AstraZeneca’s tixagevimab, cilgavimab
Covid-19 vaccine. Photo: PIB

Melbourne, Jan 4 (MNN) Australia’s Therapeutic Goods Administration (TGA) has granted further provisional approval to AstraZeneca Pty Ltd for tixagevimab and cilgavimab (Evusheld) used in prevention and treatment of Covid-19 in adolescents and adults aged 12 years and older.

The original nod of November 4, 2021 was for prevention in adults 18 years and older.

The treatment consists of monoclonal antibodies — tixagevimab and cilgavimab – which bind to the spike protein of the SARS-CoV-2 virus at two different sites.

By attaching to the spike protein, the medicine is expected to stop the virus from entering the body’s cells and causing infection, the TGA said.

The granting of a provisional determination means that the TGA has made a decision that AstraZeneca Pty Ltd is now eligible to apply for provisional registration for Evusheld in the Australian Register of Therapeutic Goods (ARTG) in this age group.

Provisional determination is the first step in the process. It is anticipated that AstraZeneca Pty Ltd will submit an application for provisional registration shortly.

Evusheld is not intended to be used as a substitute for vaccination against COVID-19.

In making its decision to grant AstraZeneca Pty Ltd a provisional determination, the TGA considered eligibility criteria, including factors such as evidence of a plan to submit comprehensive clinical data, and the seriousness of the current pandemic.

11% increase in new coronavirus cases globally, death rate unchanged: WHO

Interval down to four months between vaccination, booster dose in Australia

You May Also Like

Health

New Delhi, Jan 21 (MNN) Delhi on Friday reported 10,756 new coronavirus cases and 38 more deaths due to the virus in the last...

Europe

Paris, Jan 21 (MNN) European Health Ministers will meet on Friday via videoconference to discuss sharing of best practices for managing coronavirus crisis, as...

Cricket

Kandy, Jan 22 (MNN) Sri Lanka turned up the pressure to beat Zimbabwe by 185 runs in the third and final ODI here on...

Cricket

Paarl (South Africa), Jan 21 (MNN) South Africa eased to a comfortable seven-wicket victory in second ODI against India here on Friday to register...