The team behind the UK based third COVID-19 vaccine has announced that the results shown it has an effectiveness of between 70%-90%.
The interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine.
The news is key as the vaccine which has been developed by a team at Oxford University and drug company AstraZeneca, has been developed on a non-profit basis and is seen as the vaccine which will be mass produced for use across the world.
AstraZeneca said one dosing regimen showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen showed 62% efficacy when given as two full doses at least one month apart. The combined analysis from both dosing regimens resulted in an average efficacy of 70%. All results were statistically significant.
“More data will continue to accumulate and additional analysis will be conducted, refining the efficacy reading and establishing the duration of protection,” it added.
To put the efficacy of the drug into context the annual influenza vaccines which are distributed across the UK to those most at risk should they contract the disease has an efficacy of 70%.
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. No serious safety events related to the vaccine have been confirmed. AZD1222 was well tolerated across both dosing regimens.
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 Company will seek an Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries. In parallel, the full analysis of the interim results is being submitted for publication in a peer-reviewed journal.
Professor Andrew Pollard, Chief Investigator of the Oxford Vaccine Trial at Oxford, said: “These findings show that we have an effective vaccine that will save many lives. Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply. Today’s announcement is only possible thanks to many volunteers in our trial, and the hard working and talented team of researchers based around the world.”
AstraZeneca Chief Executive Officer, 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.”
Clinical trials are also being conducted in the US, Japan, Russia, South Africa, Kenya and Latin America with planned trials in other European and Asian countries. In total, the company expects to enrol up to 60,000 participants globally.
AstraZeneca said it is making rapid progress in manufacturing with a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval. The vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.