A third COVID-19 vaccine hits efficacy endpoint

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AstraZeneca has announced a late-stage trial of the COVID-19 vaccine it is developing with The University of Oxford has reported an average efficacy of 70 per cent but 90 per cent for one dosing regimen.

The Australian government has agreed to procure almost 34 million doses of the adenovirus viral vector vaccine. CSL is already producing the candidate at one of its Melbourne-based facilities with the first delivery scheduled for the first of 2021.

The 70 per cent average efficacy is lower than that reported for two mRNA vaccine candidates but one dosing regimen delivered 90 per cent efficacy.

The company said the vaccine (AZD1222) was 90 per cent effective when it was given as a half dose, followed by a full dose at least one month later. Another dosing regimen showed 62 per cent efficacy when given as two full doses at least one month apart.

"The combined analysis from both dosing regimens (n=11,636) resulted in an average efficacy of 70%. All results were statistically significant (p<=0.0001)," said the company in a statement.

The 70 per cent efficacy still comfortably hit the target set by the FDA.

It said an independent Data Safety Monitoring Board determined that the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine.

AstraZeneca said it will now "immediately prepare regulatory submission" of the data to authorities around the world that have a framework in place for conditional or early approval. The TGA has designated the vaccine for the provisional approval pathway.

CEO Pascal Soriot said, “Today marks an important milestone in our fight against the pandemic. This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency. Furthermore, the vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval.”

The company said it is making rapid progress in manufacturing with a capacity of up to three billion doses of the vaccine in 2021. 

The vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees celsius) for at least six months and administered within existing healthcare settings.