AstraZeneca Plc has begun final-stage, Phase III trial of its coronavirus vaccine AZD1222 in the U.S., according to the company´s latest statement.
Trial centers across the US are recruiting up to 30,000 adults aged 18 years or over from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus.
Clinical development of AZD1222 is progressing globally with similar late-stage clinical trials ongoing in the UK, Brazil and South Africa and trials are planned to start in Japan and Russia, rising hopes that the vaccine’s efficacy could be evaluated before the end of the year. These trials, together with the US Phase III clinical trial will enroll up to 50,000 participants globally.
The vaccine, invented by researchers at the University of Oxford, is one of the farthest along of numerous Covid-19 vaccine in development.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “We are pleased that AZD1222 demonstrated safety and immunogenicity across all adult age groups (…). Should clinical trials demonstrate the vaccine protects against COVID-19 disease and is approved for use, we will work hard to make it globally available in a fair and equitable manner as rapidly as possible.”
In July 2020, interim results from the ongoing Phase I/II COV001 trial were published in The Lancet and showed AZD1222 was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.
AstraZeneca affirmed it will continue to engage with governments, multilateral organizations and partners around the world to ensure broad and equitable access to the vaccine, should clinical trials prove successful. Recent supply announcements with Russia, South Korea, Japan, China, Latin America and Brazil take the global supply capacity towards three billion doses of the vaccine.
Read the Full AstraZeneca Statement for the Expansion of AZD1222 Vaccine into US Phase III Clinical Trials HERE.
View the WHO Latest Data and Information on COVID-19 HERE.