AstraZeneca Announces AZD1222 Vaccine Meets Primary Efficacy Endpoint in Preventing COVID-19

· Both different dosing regimens demonstrated efficacy, with one showing superior performance.

· No Cases of COVID-19 Hospitalization or Severe Disease Among Subjects Receiving AZD1222

On November 23, AstraZeneca announced that high-level positive results from the interim analysis of the AZD1222 clinical trials conducted in the United Kingdom and Brazil demonstrated that the vaccine was highly effective in preventing COVID-19 (the primary endpoint), with no hospitalizations or severe cases reported among vaccinated participants.

One dosing regimen (n=2,741) demonstrated a vaccine efficacy of 90% when AZD1222 was administered as a half dose (approximately 2.5×10¹⁰ viral particles), followed by a full dose (approximately 5×10¹⁰ viral particles) at least one month later; another regimen (n=8,895) showed an efficacy of 62% when two full doses were administered at least one month apart. The pooled analysis included data from the Phase 2/3 COV002 clinical trial in the United Kingdom and the Phase 3 COV003 clinical trial in Brazil. The interim analysis identified a total of 131 COVID-19 cases, and the combined analysis of both dosing regimens (n=11,636) revealed an average efficacy of 70% (p≤0.0001). AstraZeneca stated that it would continue to accumulate additional data and conduct further analyses to refine efficacy estimates and determine the duration of protection.

An independent Data Safety Monitoring Board determined that the analysis met its primary endpoint, demonstrating protection against COVID-19 occurring 14 days or more after administration of two vaccine doses. No vaccine-related serious safety events have been confirmed. AZD1222 was well tolerated in both dosing regimens.

AstraZeneca will now immediately prepare to submit data to regulatory authorities worldwide that have conditional approval or early approval frameworks. The company will seek inclusion in the World Health Organization’s (WHO) Emergency Use Listing to accelerate vaccine access pathways in low-income countries. Meanwhile, the full analysis of the interim results will be submitted for publication in a peer-reviewed journal.

Global trials are evaluating subjects aged 18 years or older, who are either healthy or have stable underlying conditions, from diverse ethnic and geographic populations. Clinical trials are also underway in the United States, Japan, Russia, South Africa, Kenya, and Latin America, with plans to conduct studies in additional European and Asian countries. The company expects to enroll a total of 60,000 subjects globally.

Pending regulatory approval, the company plans to make rapid progress toward ramping up production of 3 billion vaccine doses by 2021. The vaccine can be stored, transported, and handled under standard refrigerated conditions (2–8°C/36–46°F) for at least six months and administered within existing healthcare settings.

References:

[1] AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19. Retrieved 2020-11-23, from https://www.astrazeneca.com/media-centre/press-releases/2020/azd1222hlr.html

Source: Jike Yao Wen

▽Follow [WuXi AppTecDe】WeChat Official Account