As the UK approves the emergency use of the AstraZeneca vaccine for the first time in the world, attention is also drawn to the domestic vaccination schedule. While the US, which is the final gateway for drug approval, predicts that the time of approval will be in April next year, two months behind the original estimate, the Korean government is in a position to consider whether to use it on its own. The AstraZeneca vaccine is more likely to be vaccinated in Korea than in the United States.
Food and Drug Administration, preliminary review from October “Expected to apply for permission in early January next year”
“Refer to the overseas situation, but self-determination, US approval is not required”
On the 31st, the Ministry of Food and Drug Safety said, “Since October, we have been conducting a preliminary review of the AstraZeneca vaccine and will make its own judgment regardless of whether or not the foreign government approves it.”
The government has concluded a vaccine contract with AstraZeneca, a vaccine developer for the novel coronavirus infection (Corona 19). yunhap news
As the analysis of the results of the final clinical trial has not yet been completed, the submitted nonclinical/phase 1 trial data are being examined first. Sang-Bong Kim, head of the Bio-Pharmaceutical Bureau of the Ministry of Food and Drug Safety, said, “Usually, the review starts only when the data are in place, but in order to shorten the approval review period, we are reviewing in advance as soon as the data are submitted. The government previously announced that it will aim to shorten the treatment period for treatments and vaccines, which usually takes 6 months, to reach a conclusion within 40 days.
The Ministry of Food and Drug Safety expects that AstraZeneca will apply for approval by submitting the remaining clinical data in early January next year.
Of course, it does not mean that it can be distributed and sold immediately if it is licensed. Vaccines must go through the national shipment approval process once more. The Ministry of Food and Drug Safety said that this period, which usually takes 2-3 months, will be reduced to about 20 days. It is said that it takes up to 60 days physically to complete the shipment approval following the approval, but as the matter is urgent, the Ministry of Food and Drug Safety explained that it will apply for shipment approval in advance and promote it at the same time if some screening is completed even before approval. Director Kim Sang-bong said, “We will thoroughly verify the safety and effectiveness, but we will shorten it by one day as far as possible so that there is no disruption in the vaccination schedule.”
Supply schedule for each COVID-19 vaccine. Graphic = Younghee Kim [email protected]
Could the overseas situation affect the domestic licensing process? In the UK, AstraZeneca was approved for emergency use for the first time in the world on the 30th (local time), but in the United States, it is expected to be granted only in April next year. According to foreign media, the US Food and Drug Administration (FDA) delaying the expected approval date seems to have been influenced by questions surrounding the effect, such as that little is known about the effect of preventing the elderly in the existing clinical trials.
Kim Hee-sung, head of the rapid review section of the Korea Food and Drug Administration, said, “It seems that the clinical trial itself has been delayed in the US rather than the prevention effect of the elderly.” It started again in the month or so. It seems that patient registration is now complete as it has been suspended for a long time and resumed.”
On the 30th (local time), Dr. Monsef Slawi, chief executive of the Trump administration’s corona vaccine development program’Super-fast operation’, said that the recruitment of participants was almost finished with 29,000 enrolled in the phase 3 clinical trial.
In this regard, Director Kim Sang-bong said, “We plan to seek domestic expert advice after understanding what data has been approved by countries that have approved AstraZeneca, such as the UK, and why additional reviews are needed in the United States.” The KFDA’s position is that it will refer to the overseas situation but will not be subordinated to it and will decide on its own even before FDA approval.
FDA headquarters in Silver Spring, Maryland, USA. Shinhwa News = Yonhap News
Manager Hee-seong Kim said, “It is generally referring to the situation of foreign countries, but FDA approval is not a prerequisite.” “Of imported medicines, the FDA has not been approved, but there are many cases that have been approved by the European side. The same is true for vaccines,” he said. “It may be different from the US, but it is expected to proceed similarly to the European Medicines Agency (EMA) without much difference.”
Dae-seop Song, a professor at Korea University’s College of Pharmacy, said, “The review by the Korean Food and Drug Administration is usually more difficult and more conservative than FDA or EMA. “I’m not really concerned about reliability issues.”
AstraZeneca is the first vaccine that we signed a contract to purchase 10 million people in November. According to the quarantine authorities, 750,000 AstraZeneca vaccines will be delivered in the first phase from February to March next year. The authorities stress that they will prepare as much as possible so that the vaccine can be given on schedule as soon as it is brought in. At a briefing on the 31st, the Korea Centers for Disease Control and Prevention (KCDC) Commissioner Jeong Eun-kyung said, “We have prepared detailed action plans such as targets to be vaccinated, methods of vaccination, and designation of vaccination institutions. I said. Chung said, “It is expected that a lot of supplies will be supplied from the third quarter. We will increase the vaccinations as much as possible until the third quarter.”
Government “progress in mode or negotiation”
Regarding the contract with Modena, Commissioner Chung said, “We are reviewing the purchase contract,” and said, “There has been progress in the contents of the negotiations, and I will tell you quickly when the negotiations are finally concluded.” Regarding the point that there is a temperature difference from the announcement of the Blue House as Moder or the side expressed that it is not consensual, it is said that there is a temperature difference from the announcement of the Blue House. We continue to discuss it because it is a part that ends only after signing and contracting.”
When asked about the introduction plan of the Chinese pharmaceutical company Sinopharm’s announcement that its vaccine’s preventive effect was more than 79%, he said, “Because we have confirmed the quantity for about 56 million people, we have not yet been discussing the additional quantity.” .
Reporter Hwang Soo-yeon [email protected]