AstraZeneca/Oxford Vaccine for COVID-19 Achieves Interim Efficacies of 90% and 62% in Trials of Two Different Dose Regimens; Up to 3 Billion Doses Planned for 2021

Positive high-level results from an interim analysis of clinical trials of the COVID-19 vaccine AZD1222, manufactured by AstraZeneca and co-invented by the University of Oxford and its spin-out company Vaccitech, tested in the UK and Brazil, 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. The announcement was made on November 23, 2020. There were a total of 131 COVID-19 cases in the interim analysis. AZD1222 uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body. In the interim results, one dosing regimen (n=2,741) 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 (n=8,895) showed 62% 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). 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 (DSMB) 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.
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