Cambridge, United Kingdom-based AstraZeneca, working in collaboration with Oxford University, found the vaccine to be highly effective in preventing COVID-19 for subjects in the UK and Brazil, with no hospitalizations or severe cases of the disease reported in those who received the vaccine among 131 COVID-19 cases in the interim analysis, according to a news release.
A dosing regimen that involved giving the AZD1222 vaccine as a half dose, followed by a full dose at least one month apart, showed an efficacy of 90%. A dosing regimen of two full doses given one month apart showed 62% efficacy, with the combined analysis from both regimens resulting in 70% efficacy.
Pooled analysis of over 23,000 participants in the UK and Brazil assessed the subjects after one of the two dosing regimens or a comparator, meningococcal conjugate vaccine called MenACWY or saline. The trials included patients aged 18 or older. Additionally, clinical trials are being conducted in the U.S., Japan, Russia, South Africa, Kenya and Latin America with further trials planned and 60,000 participants expected to be enrolled globally.
The company is ramping up manufacturing to a capacity of 3 billion doses in 2021 on a rolling basis, pending regulatory approval. The vaccine candidate can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and can be administered within existing healthcare settings.
AstraZeneca continues to engage with governments, multilateral organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic
The company said an independent safety monitoring board determined that the analysis met its primary endpoint in showing protection from COVID-19 occurring 14 days or more after receiving two doses. No serious adverse events related to the vaccine were confirmed after the company had to voluntarily pause multiple trials following unexplained illnesses.
AstraZeneca plans to immediately prepare for the regulatory submission of its trial data to authorities around the world to garner early approval for the vaccine. It said in the release that it plans to seek emergency use listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries.
The AZD1222 vaccine candidate joins candidates from Pfizer and BioNTech, as well as one from Moderna, both of which recently reported data as they move toward seeking regulatory approval.
“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,” chief trial investigator Andrew Pollard said in the release. “Today’s announcement is only possible thanks to the many volunteers in our trial, and the hard-working and talented team of researchers based around the world.”
“Today marks an important milestone in our fight against the pandemic,” added AstraZeneca CEO Pascal Soriot. “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.”
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease