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· Two different dosing options showed efficacy, one of which performed better. Among the subjects who received AZD1222, no COVID-19 hospitalization or severe cases on 23 November, AstraZeneca announced that high levels of positive results from mid-term analysis of clinical trials of AZD1222 from the United Kingdom and Brazil showed that the vaccine was very effective in preventing COVID-19 (the primary endpoint) and that no hospitalization or severe cases were reported among subjects receiving the vaccine.
a dosing programme (n=2,741) shows that when AZD1222 is given in half dose (approximately 2.5×1010 virus particles), then given at least one month apart after the full dose (About 5×1010 virus particles) with 90 per cent vaccine effectiveness, and another regimen (n-8,895) showed that the vaccine was 62 per cent effective when given at full dose and then given at least one month apart.
summary analysis included data from COV002 of Phase 3 clinical trials in the United Kingdom and COV003 from Phase 3 clinical trials in Brazil, with a total of 131 COVID-19 cases in the interim analysis, and a combined analysis of two dosing options (n-11,636) showing an average efficacy of 70% (p-lt;0.0001).
said it would continue to accumulate more data and conduct more analysis to refine efficiency readings and determine the duration of protection.
independent data security monitoring committee determined that the analysis reached its primary endpoint and showed the protection of COVID-19 that occurred 14 days or more after two doses of the vaccine.
have not confirmed serious vaccine-related safety incidents.
AZD1222 showed good tolerance in both dosing options.
will now be ready to submit data to regulators around the world with conditional or early approval frameworks.
will seek inclusion in the Emergency Use List from the World Health Organization to speed up the availability of vaccines in low-income countries.
, a complete analysis of the interim results will be submitted to a peer-reviewed journal for publication.
global trials are evaluating patients aged 18 or older from different ethnic and geographic groups with stable underlying diseases.
trials are also under way in the United States, Japan, Russia, South Africa, Kenya and Latin America, with trials planned in other European and Asian countries.
is expected to recruit 60,000 subjects worldwide.
to make rapid progress in rolling production of 3 billion doses of the vaccine by 2021, pending regulatory approval.
vaccine can be stored, transported and treated for at least 6 months under normal refrigeration conditions (2-8 degrees C/36-46 degrees Fahrenheit) and inoculated in an existing health care environment.
resources: aZD1222 vaccine met primary efficacy endpoint in preventing COVID-19. Retrieved 2020-11-23, from Source: Supplied