AstraZeneca’s COVID-19 Vaccine AZD1222 Trial Results
AstraZeneca’s COVID-19 Vaccine AZD1222 Trial Results. Two different dosage regimens, one of which is better! Results of Phase III clinical trial of AstraZeneca’s COVID-19 vaccine AZD1222!
The high-level positive results of the interim analysis of the AZD1222 clinical trials in the United Kingdom and Brazil showed that the vaccine is very effective in preventing the primary endpoint of COVID-19, and the vaccinated participants have not reported hospitalization or serious cases. There were a total of 131 COVID-19 cases in the interim analysis.
One dosing schedule (n=2,741) showed that when AZD1222 was used in half dose, 90% of the vaccine’s effectiveness, and then used at full doses at least one month apart, another dosing schedule (n=8,895) showed When two full doses are used, the effectiveness of the vaccine at least one month apart is 62%. The combined analysis of the two dosing regimens (n=11,636) results in an average curative effect of 70%. All results are statistically significant (p<=0.0001). Will continue to accumulate more data and conduct more analyses to improve the efficacy readings and determine the protection period.
An independent data security monitoring committee determined that the analysis reached its primary endpoint, which is a protective effect against COVID-19 within 14 days or longer after the two doses of the vaccine. No serious safety incidents related to the vaccine have been confirmed. AZD1222 was well tolerated in both dosage regimens.
AstraZeneca will immediately prepare to submit these data to regulatory agencies around the world with conditions or early approval of the framework. The company will seek an emergency use list from the World Health Organization to expedite access to vaccines in low-income countries. At the same time, a comprehensive analysis of the interim results is being submitted for publication in a peer-reviewed journal.
Professor Andrew Pollard, the lead researcher of the Oxford Vaccine Trial at the University of Oxford, said: “These findings show that we have an effective vaccine that can save many lives. What is exciting is that we have discovered that one of our dosage regimens may be possible. There is about 90% effect. If this dosage regimen is used, more people can be vaccinated with the planned vaccine supply. This news can be announced today, thanks to the many volunteers who participated in the trial, as well as the hard work and talented people from all over the world research team.”
CEO Pascal Soriot said: “Today is an important milestone in our fight against this pandemic. The effectiveness and safety of the vaccine confirms that it will be highly effective against COVID-19 and will be beneficial to public health this time. Emergencies have an immediate impact. In addition, the simple supply chain of this vaccine, and our non-profit commitments and commitments to widespread, fair and timely access, means it will be affordable and available globally, Provide hundreds of millions of approved vaccines.”
The combined analysis includes data from the UK COV002 Phase II/III trial and Brazil’s COV003 phase trial. More than 23,000 participants were evaluated after taking two doses of AZD1222, one with a half-dose/full-dose regimen, and the other with two full-dose regimens or a contrast agent, namely MenACWY or saline meningococcal conjugate vaccine. The global trial is evaluating participants from different ethnic and geographic groups, who are 18 years of age or older, healthy, or have a stable underlying disease.
The United States, Japan, Russia, South Africa, Kenya and Latin America are also conducting clinical trials, and plans to conduct trials in other European and Asian countries. The company expects to recruit up to 60,000 participants worldwide.
The company is making rapid progress in vaccine production. The rolling production capacity will reach 3 billion doses in 2021 and is currently awaiting regulatory approval. The vaccine can be stored, transported and processed under normal cold storage conditions (2-8 degrees Celsius / 36-46 degrees Fahrenheit) for at least 6 months, and managed in existing health care facilities.
AstraZeneca continues to cooperate with governments, multilateral organizations and partners around the world to ensure widespread and fair access to unprofitable vaccines during the pandemic.
COV002 is a single-blind, multicenter, randomized, controlled phase II/III trial that evaluated the safety, efficacy and immunogenicity of AZD1222 in 12390 participants in the United Kingdom. To date, trial participants are 18 years of age or older, they are healthy or have medically stable chronic diseases, and their risk of exposure to the SARS-CoV-2 virus is increased. Participants received 1-2 intramuscular injections, half-dose (~2.5 x1010 virus particles) or full dose (~5×1010 virus particles) AZD1222 or control agent, meningococcal vaccine MenACWY. Participants’ blood samples were taken at various time points one year after vaccination and clinically evaluated for safety and immunogenicity. COVID-19 PCR testing was performed on suspected cases with compatible symptoms for virological confirmation. In addition, swab checks are performed every week to detect infection and evaluate the anti-infective effect of the vaccine.
COV003 is a single-blind, multi-center, randomized, controlled phase III trial that evaluated the safety, efficacy and immunogenicity of AZD1222 in 10,300 participants in Brazil. To date, trial participants are 18 years of age or older, they are healthy or have medically stable chronic diseases, and their risk of exposure to the SARS-CoV-2 virus is increased. Participants were randomly given two intramuscular doses, the full dose (~5×1010 virus particles) of AZD1222 or the comparator, the meningococcal vaccine MenACWY as the first dose and the saline placebo as the second dose. Participants’ blood samples were taken at various time points one year after vaccination and clinically evaluated for safety and immunogenicity. COVID-19 PCR testing was performed on suspected cases with compatible symptoms for virological confirmation.
AZD1222 was jointly invented by Oxford University and its subsidiary company Vaccitech. It uses a replication-deficient chimpanzee virus vector based on a weakened version of the common cold virus (adenovirus), which causes chimpanzee infection and contains genetic material of the SARS-CoV-2 virus spike protein . After vaccination, the surface spike protein will be produced. Once the SARS-CoV-2 virus infects the human body, the immune system will initiate an attack.