The TGA has provisionally approved AstraZeneca's preventative COVID-19 medication. 

The Therapeutic Goods Administration (TGA) has granted provisional approval to AstraZeneca for its drugs tixagevimab and cilgavimab (EVUSHELD) for the prevention of COVID-19 in people who are at risk of infection but have not been exposed to the virus, known as pre-exposure prevention of COVID-19.

EVUSHELD has been granted provisional approval for the pre-exposure prophylaxis (prevention) of COVID-19 in people aged 12 years and older weighing at least 40 kg:

  • who have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments that make it likely that they will not mount an adequate immune response to COVID-19 vaccination; or

  • for whom vaccination is not recommended due to a history of severe adverse reaction to a COVID‐19 vaccine or COVID‐19 vaccine component

“Pre-exposure prevention with EVUSHELD is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended,” the regulator said in a statement.

Experts say the new drugs are very important tools. 

“Pre-exposure prophylaxis is a preventative treatment usually given to people at high risk of disease … such as those who are immunocompromised or immunosuppressed,” says Dr Cassandra Berry - a Professor in Viral Immunology at Murdoch University.

“In this case, two types of monoclonal antibodies (pre-made synthetic antibodies against the spike viral protein) are administered to individuals ahead of potential exposure or soon after infection with the virus. 

“They will bind and block the virus from entering the body’s cells and significantly reduce the risk of developing symptomatic COVID-19. 

“This is a form of passive immunity rather than active immunity.

“Pre-exposure prophylaxis with these antibodies is only effective for about six months and does not last forever. So, it is a complimentary protective measure for COVID and is not a substitute for vaccination, which does induce immune memory.”

Dr Jaya Dantas - Professor of International Health in the School of Population Health at Curtin University - says it is an important step forward. 

“A significant proportion of the immunocompromised don't respond to COVID-19 vaccines, so despite being vaccinated, they are unsure if they are protected or not,” Dr Dantas says.

“This priority group is also at a higher risk of other infections, and COVID-19 was a significant threat that impacted their lives.”

The TGA’s provisional approval “will give immense hope to this group and those who could not be vaccinated due to medical conditions that can cause adverse reactions to vaccines”, Dr Dantas says.