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According to the AstraZeneca notification, one of the immunization schedules (n = 2741) showed that when AZD1222 was given as a half dose and then given at least one month apart in a full dose, the effectiveness of the vaccine was 90 %; the other This immunization schedule (n = 8895) shows that when AZD1222 is given as a full dose for one dose, followed by a full dose at least one month apart, the effective rate of the vaccine is 60%. The combined analysis of the two immunization programs (n = 11636) resulted in an average effective rate of 70%. All the results are statistically significant (p≤0.0001). More data will continue to be accumulated and additional analysis will be conducted to refine the efficacy data and determine the period of protection.
An independent Data Safety Monitoring Board (DSMB) determined that the analysis reached the primary end point: protection against COVID-19 within 14 days or more after the 2 doses of the vaccine. No serious vaccine-related safety incidents have been found. Between the two immunization schedules, AZD1222 was well tolerated.
Now AstraZeneca will immediately prepare to submit data to regulatory agencies around the world that have conditional or advance approval of the framework. The company will apply to the World Health Organization (WHO) to include AZD1222 on the Emergency Use List (Emergency Use List) to speed up access to vaccine supplies in low-income countries. At the same time, a full analysis of the interim results will be published in a peer-reviewed journal.
Pascal Soriot, CEO of AstraZeneca, said: “Today is an important milestone in our fight against the COVID-19 pandemic. The efficacy and safety results of this vaccine have confirmed its high efficacy in preventing COVID-19, and It will have a direct impact on this public health emergency. Additionally, the vaccine’s simple supply chain, our non-profit commitment, and our commitment to widespread, fair, and timely access to the vaccine means that it will be affordable. provide globally and hundreds of millions of doses of vaccine can be delivered after approval. “
This summary analysis includes data from the UK COV002 phase II / III trial and the Brazil COV003 phase III trial. More than 23,000 subjects received 2 immunization regimens (half dose / full dose regimen, 2 full dose regimen) or a control vaccine (MenACWY conjugate meningococcal vaccine) or normal saline, and are currently being evaluated. These global trials are evaluating healthy or stable subjects with underlying diseases 18 years of age or older from different ethnic and geographic groups.
AstraZenecaProduction is progressing rapidly and production capacity will reach 300,000 doses in 2021. AZD1222 vaccine can be stored, transported and processed under normal refrigeration conditions (2-8 degrees Celsius / 36-46 degrees Fahrenheit) for at least 6 months and administered in existing medical institutions.
AstraZeneca will continue to work with governments, multilateral organizations and partners around the world to ensure broad and fair access to unprofitable vaccines during the COVID-19 pandemic. (Bioon.com)
Original Source: AZD1222 Vaccine Met Primary Efficacy Endpoint in Preventing COVID-19