AstraZeneca announces 90% efficacy with COVID-19 vaccine
AstraZeneca announced positive high-level results (90%) from an interim analysis of clinical trials of their AZD1222 vaccine for COVID-19 prevention in the UK and Brazil.
Results showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalizations or severe cases of the disease were reported in participants receiving the vaccine. There were a total of 131 COVID-19 cases in the interim analysis.
One dosing regimen showed vaccine efficacy of 90 percent when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen showed 62 percent 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 percent. 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.
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 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.
The pooled analysis included data from the COV002 Phase II/III trial in the UK and COV003 Phase III trial in Brazil. Over 23,000 participants are being assessed following two doses of either a half-dose/full-dose regimen or a regimen of two full doses of AZD1222 or a comparator, meningococcal conjugate vaccine called MenACWY or saline. The global trials are evaluating participants aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions.
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 enroll up to 60,000 participants globally.
The company is making rapid progress in manufacturing with a capacity of up to three 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 (two to eight degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.
AstraZeneca continues to engage with governments, multilateral organizations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.
