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“Tight verification of safety and efficacy … Review target within 40 days”
The Ministry of Food and Drug Safety announced on the 4th that it had started the approval and review of the Korea AstraZeneca Corona 19 Vaccine (code name AZD1222) as a permit application for the product had been received.
According to the Ministry of Food and Drug Safety, the vaccine requested for approval this time is a vaccine developed by AstraZeneca as a new drug, and it is a ‘viral vector vaccine’ manufactured by placing the corona virus 19 surface antigen gene in a chimpanzee adenovirus template. Viral vector vaccines are made by inserting genes from viral antigens that cause infectious diseases into other viral genes used as carriers and mass-producing them.
The AstraZeneca vaccine uses ‘adenovirus’ that only infects chimpanzees as a delivery vehicle to deliver the corona virus 19 surface antigen gene into human cells, and the delivered corona antigen gene synthesizes antigenic proteins in the body to induce production of neutralizing antibodies. 19 When a virus invades, it is neutralized and eliminated.
The expected target for the AstraZeneca vaccine is 18 years of age or older, and the expected dose is 2 times higher 4 to 12 weeks after 1 vaccination. This is the same as the UK emergency use approved use and dosage, and storage conditions are 2-8 ℃.
Meanwhile, AstraZeneca is known to be conducting phase 3 clinical trials in more than 10 countries, including the UK, Brazil, and the US.
The AstraZeneca vaccine was performed clinically in healthy people over 18 years of age, including those over 65 in the UK and Brazil.
The clinical trial was discontinued (September 6, 2020) due to an unexpected serious adverse event (one case of transverse myelitis) during the clinical trial, but as a result of the safety review, the clinical trials were resumed due to no direct association with vaccine (UK, etc.) September 12, 2020 and October 23, 2020 in the United States).
The UK confirmed the preventive effect in 1,636 people in the AstraZeneca vaccine clinical trial and approved it for emergency use on December 30, and the European Medicines Agency (EMA) has been conducting a preliminary review since October last year. .
In addition, the World Health Organization (WHO) Emergency Use List (EUL) was also requested, and the global vaccine supply procedure is also being applied.
The Ministry of Food and Pharmaceutical Safety plans to thoroughly verify safety and efficacy by reviewing experts in each field and external experts from the ‘Crown 19 Treatment / Vaccine License Review Team’.
In particular, it aims to shorten the existing processing period (180 days or more) and process it within 40 days for rapid approval and review of the Corona 19 vaccine and treatment.
Additionally, Corona 19 vaccines are subject to expedited shipment approval and will be treated with priority over other domestic shipment approval drugs, and domestic shipment approval, which typically takes 2-3 months or more, is expected to be will complete quickly in 20 days.
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