TGA's recommendations on recognition of vaccines not registered in Australia
Coronavac (Sinovac) showed an average VE against symptomatic infection of 64% and an average VE against hospitalisation of 90%.

VE against symptomatic infection (surrogate for transmission) of 54%, 54%, 64%, 66% and 84% in five studies.
VE against severe infection/hospitalisation of 100%, 100%, 88% and 73% in four trials.
The standard schedule of Coronavac is 2 doses administered 14-28 days apart.

Based on regulatory, published and pre-print data this suggests the efficacy of Coronavac is comparable to the Australian-approved vaccines, although marginally lower in protection against symptomatic infection.

TGA thus considers that the Coronavac (Sinovac) vaccine is a "recognised vaccine".

BBIBP-CorV (Sinopharm China) showed an average VE against symptomatic infection of 65%. VE against hospitalisation has not been estimated.

VE against symptomatic infection (surrogate for transmission) of 50% and 79% from two studies.
No studies are available to determine VE against severe infection/hospitalisation
Based on published and pre-print data this suggests that the efficacy of BBIBP-CoV against symptomatic infection is slightly lower than Australian-approved vaccines, and there is currently no assessment of protection it offers against severe-infection/hospitalisation.

TGA thus considers that BBIBP-CorV (Sinopharm) not be a "recognised vaccine" at this stage, because of the absence of information on severe infection/hospitalisation.

Covishield (AstraZeneca/Serum Institute of India) is manufactured using the same ChAdOx1-S recombinant virus as the AstraZeneca (Vaxzevria) vaccine to produce the same dose of virus in the final product. The two are considered interchangeable by the World Health Organisation. TGA considers COVISHIELD to have the same clinical efficacy as Vaxzevria for this assessment. Two major global regulators, the UK Medicines and Health products Regulatory Agency and Health Canada have provided regulatory approvals for the AstraZeneca vaccine manufactured by the Serum Institute of India. These regulators are recognised in regulation as "Comparable Overseas Regulators" by the TGA.

Therefore, the clinical efficacy and effectiveness data for Vaxzevria (AstraZeneca) are relevant in this case. The average VE against symptomatic infection is 65% and severe infection and/or hospitalisation is 85%.

TGA thus considers that the Covishield (AstraZeneca/Serum Institute of India) vaccine is a "recognised" vaccine.

Covaxin (Bharat Biotech, India) showed an average VE against symptomatic infection of 78% and an average VE against hospitalisation of 94%.

VE against symptomatic infection (surrogate for transmission) of 78% in one study.
VE against hospitalisation of 93% in one study.
The standard schedule of Covaxin is two doses administered 28 days apart.

Because this is an un-refereed pre-print, and we have not yet been provided with a regulatory dossier, TGA has not reached a conclusion on whether Covaxin be a "recognised vaccine".

Sputnik V (Gamaleya Institute, Russian Federation) showed an average VE against symptomatic infection of 92% and VE against hospitalisation of 100%.

VE against symptomatic infection (surrogate for transmission) of 92% from one study.
VE against hospitalisation of 100% from one study.
Because this is only a single study, and we have not yet been provided with a regulatory dossier, TGA has not reached a conclusion on whether Sputnik V be a "recognised vaccine".

For the unregistered vaccines that are granted recognition, effective vaccination would be considered to extend from 14 days after the last dose of the schedule (which is currently two doses (except for Janssen)), but may be a booster doses six to twelve months after the last dose of the schedule. This is based on generalising the data from duration of immunity studies reviewed in the absence of specific studies in the unregistered vaccines.

For Convidecia (Cansino), there are currently no published or pre-print studies on which to base an assessment of the efficacy of Convidecia and the TGA has not yet been provided with a regulatory dossier.

Because there is insufficient data to evaluate the efficacy of the vaccine, TGA has not yet reached a conclusion on whether Convidecia (Cansino) should be a "recognised vaccine".