AZ authorizes the COVID-19 vaccine conditionally in Europe



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Third vaccine approved in Europe … 2 doses older than 18 years

The European Commission has approved the use of the COVID-19 vaccine by AstraZeneca.

▲ AstraZeneca Corona 19 vaccine is conditionally licensed for use in Europe by inoculating adults 18 years of age and older twice at 4 to 12 week intervals.
▲ AstraZeneca Corona 19 vaccine is conditionally licensed for use in Europe by inoculating adults 18 years of age and older twice at 4 to 12 week intervals.

AstraZeneca said 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 18-year-old targets. of age or older. Announced. The AstraZeneca 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) that contains the genetic material of the SARS-CoV-2 virus spike protein. After inoculation, a surface spike protein is produced that prepares the immune system to attack the virus if it becomes infected with the SARS-CoV-2 virus.

The Advisory Committee of Medicines Users (CHMP) of the European Medicines Agency presented a positive opinion on the results of a complementary review of the clinical trial data of the first analysis of the phase 3 clinical program of the corona vaccine19 led by the University from Oxford in the UK.

The AstraZeneca vaccine was evaluated in four clinical trials conducted with approximately 24,000 participants in the UK, Brazil and South Africa. Efficacy was analyzed by European authorities based on the results of clinical trials in the UK and Brazil where COVID-19 cases they were enough. The AstraZeneca vaccine was found to be around 60% effective while reducing symptomatic cases of COVID-19 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 older people, saying that the results are not yet sufficient for 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.

The CHMP recommended that AstraZeneca Corona 19 vaccine, AZD1222, be administered twice at 4 to 12 week intervals for people 18 years of age and older. This dosing regimen has been shown to be safe and effective in preventing symptomatic COVID-19 in clinical trials, and no serious cases or cases of hospitalization have been reported after 14 days or more after the second vaccination.

AstraZeneca is working with European authorities to initiate vaccination in EU member states. In addition, we are discussing with national regulatory agencies to promote urgent vaccine supply or conditional approval worldwide, and have decided to apply for inclusion in the emergency use list with the World Health Organization (WHO) so that the vaccine is readily available at low cost. -countries of income.

“Today’s approval shows the value of AstraZeneca’s COVID-19 vaccine,” said Pascal Soriot, CEO of AstraZeneca. This vaccine is not only effective and well tolerated, it is also easy to handle and completely prevents serious illness and hospitalizations. “We are deeply grateful for the continued dedication of the University of Oxford, 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 is committed to ensuring broad and equitable access to no-benefit vaccines 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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