Input 2020.12.28 17:41
According to the Corona 19 vaccine introduction schedule announced by the government on the 28th, the AstraZeneca vaccine is expected to be supplied to Korea as early as next February among global pharmaceutical companies.
According to foreign media such as Bloomberg, the UK Medicines and Health Management Product Regulatory Authority (MHRA) is scheduled to announce whether AstraZeneca has applied for emergency use of the Corona 19 vaccine during this week.
Pascal Sorio AstraZeneca’s CEO (CEO) told The Times’ Sunday Times on the 27th (local time), “We have found a formula for success that can benefit from the two doses of the (Corona 19) vaccine.” 19 Confident of the success of vaccine development. A professor of infectious medicine at a university hospital in Korea predicted that “MHRA’s approval for the emergency use of the AstraZeneca Corona 19 vaccine is a domestic vaccine, so there is a high possibility that the arm will bend.”
The Corona 19 vaccine, which AstraZeneca is jointly developing with Oxford University, is considered the first vaccine that the Korean government will obtain and inoculate. The government’s plan is to start vaccination as soon as possible in February of next year as soon as the vaccine is available.
However, domestic experts point out that the efficacy and safety of AstraZeneca’s COVID-19 vaccine is lacking in data that can be clearly judged compared to Pfizer and Modena. Unlike Pfizer and Modena, AstraZeneca has not yet completed phase 3 clinical trials. It is also known that the preventive effect varies depending on the dose administered in the vaccine during the phase 3 clinical trial, and reliability is also cracked.
Kim Woo-joo, a professor of infectious medicine at Korea University’s Guro Hospital, said, “It’s not that AstraZeneca’s COVID-19 vaccine is not good, but compared to Pfizer and Modena, the clinical trial data etc. are insufficient. “In clinical trials in the United States, the standards required by the Food and Drug Administration (FDA) have not been met.” He explained that it was not able to recruit more than 30,000 participants in the clinical trials required by the FDA, and the safety of the Corona 19 vaccine, which is administered twice, should be observed for at least 2 months after the second vaccination, which is not even within this period. The issue of AstraZeneca’s dose of the Corona 19 vaccine was raised in November.
The quarantine authorities said they would review the safety and efficacy of vaccines imported domestically by the Ministry of Food and Drug Safety apart from the approval of foreign authorities such as the US FDA, but the domestic Food and Drug Administration, which had trusted the FDA, did not complete clinical trials. It is not known whether it will be possible to draw conclusions faster than the FDA on the approval. The completion of phase 3 clinical trials of the AstraZeneca Corona 19 vaccine is expected in the middle of next year.
Jae-wook Choi, a professor of preventive medicine at Korea University Medical School, said, “If we first approve (Corona 19 vaccine), it should be understood that it is based on US FDA approval.” “The AstraZeneca vaccine can be approved in late February or early March next year,” said Monsef Slawi, chief executive of the high-speed operations team, the US health authority’s rapid response department, on the 23rd (local time).
The quarantine authorities predicted the corona 19 vaccine vaccination period from February to March at the regular Corona 19 briefing, and in the separate explanatory data, only the AstraZeneca vaccine and the vaccine through CoVax Facility were scheduled to be introduced in the first quarter. Professor Kim Woo-joo said, “It is safe to approve (Corona 19 vaccine) in the US and Europe, and we approve it based on the data.”