3rd vaccine approved in Europe…2 doses over 18 years of age
The European Commission has approved AstraZeneca’s use of the COVID-19 vaccine.
AstraZeneca said that its Corona 19 vaccine was conditionally sold in the European Union (EU) on the 29th (local time) for the purpose of inducing active immunity to prevent COVID-19 caused by SARS-CoV-2 in targets 18 years of age or older. Announced. AstraZeneca’s vaccine is the third corona19 vaccine approved in the European Union.
AstraZeneca’s COVID-19 vaccine uses a replication-defective chimpanzee virus vector based on an attenuated cold virus (adenovirus) containing the genetic material of the SARS-CoV-2 virus spike protein. After inoculation, a surface spike protein is produced, preparing the immune system to attack the virus if infected with the SARS-CoV-2 virus.
The European Medicines Agency’s Drug User Advisory Committee (CHMP) presented a positive opinion on the results of a companion review of the clinical trial data from the first analysis of the corona19 vaccine phase 3 clinical program led by Oxford University in the UK.
AstraZeneca’s vaccine was evaluated in four clinical trials conducted with approximately 24,000 participants in the UK, Brazil, and South Africa.European authorities analyzed the efficacy based on the results of clinical trials in the UK and Brazil where COVID-19 cases were sufficient. . The AstraZeneca vaccine was found to have an efficacy of about 60% while reducing symptomatic COVID-19 cases by 59.5% compared to the control vaccine.
Most of the participants in this trial were between the ages of 18 and 55. The European Medicines Agency recommended that it can be used even in elderly people, saying that the results are not yet sufficient for elderly people over 55 years of age, but the preventive effect is expected based on the experience of immune responses and other vaccines.
Additional safety and efficacy data for the vaccine will continue to accumulate in ongoing clinical trials and are expected to be released in the coming weeks.
CHMP recommended that the AstraZeneca Corona 19 vaccine, AZD1222, be administered twice at intervals of 4 to 12 weeks for persons 18 years of age or older. This dosage regimen has been shown to be safe and effective in preventing symptomatic COVID-19 in clinical trials, and no serious cases or hospitalization cases have been reported after 14 days or more after the second vaccination.
AstraZeneca is working with European authorities to initiate vaccinations in EU member states. In addition, we are discussing with national regulatory agencies to promote urgent vaccine supply or conditional approval around the world, and have decided to apply for emergency use list listing with the World Health Organization (WHO) in order to make the vaccine available quickly in low-income countries. .
“Today’s approval shows the value of AstraZeneca’s COVID-19 vaccine,” said AstraZeneca’s CEO Pascal Soriot. This vaccine is not only effective and well tolerated, but also easy to manage and completely prevents serious illness and hospitalization. “We are deeply grateful for the continued dedication of Oxford University, clinical trial participants, and AstraZeneca colleagues for their contributions to providing life-saving vaccines to millions of Europeans.”
AstraZeneca’s COVID-19 vaccine can be stored, transported, and handled at normal refrigerated temperatures (2-8 degrees Celsius), and can be administered under existing medical conditions. AstraZeneca has committed to ensuring broad and equitable access to vaccines without benefit during the global pandemic, and to this end, we continue to work with governments, international organizations and partners around the world.
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