Food and Drug Administration, AstraZeneca Vaccine License Review Begins … How Long Will It Take?

The Ministry of Food and Drug Safety has initiated an article approval review for the AstraZeneca Corona 19 ‘AZD1222’ vaccine. The permit review process is expected to be completed in 40 days.

In a regular briefing at the Defense Countermeasures Headquarters on the 4th, Kim Sang-bong, head of the Biopharmaceutical Office of the Ministry of Food and Drug Safety, explained the review process for future approval, saying: “Today , AstraZeneca Korea has submitted the application for approval and related data to the Ministry of Food and Drug Safety. ” .

The vaccine that is subject to approval this time is a virus vector vaccine made by placing the corona virus 19 surface antigen gene into a chimpanzee adenovirus template. It is the same method as the Janssen vaccine (Johnson & Johnson).

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 goal of vaccination is to be 18 years of age or older, and final immunity is created with the second vaccine, which is given 4 to 12 weeks after the first vaccination. Storage conditions for the vaccine are 2-8 ℃.

The vaccine has already started in the UK, the first in the world to approve the vaccine. However, Europe and the United States have not yet approved the use of the AstraZeneca vaccine because the vaccine is not reliable.

There are two types of permit applications submitted by Korea AstraZeneca (hereinafter AstraZeneca) to the Ministry of Food and Drug Safety. AstraZeneca simultaneously applied for a license to manufacture and sell products for SK Bioscience, a manufacturer of domestic shipments, and to import products for products produced abroad, such as Italy.

The Ministry of Food and Pharmaceutical Safety will evaluate non-clinical trials, clinical trials, quality, risk management plans, manufacturing data and quality control for the approval of the vaccine.

Among these, the non-clinical test data refers to the results of animal tests, and the clinical test data describes the results of administration to humans. The Ministry of Food and Drug Safety is planning to decide whether to approve it by reviewing how excellent the AstraZeneca vaccine has a preventive effect through related data. As long as there is no major misrepresentation about the preventative effect that AstraZeneca has disclosed thus far, approval and approval are expected to be done quickly.

The preventive effect of the AstraZeneca vaccine, which has been discovered so far, is estimated to be around 70%. Pfizer, which is known to have a preventive effect of around 95%, is less effective than the modder or the vaccine. Even so, a clear preventive effect has not been revealed for reasons such as clinical phase 3, which is delayed compared to other products.

However, considering the fact that the World Health Organization (WHO) recommends the standard of preventive effect of the COVID-19 vaccine of 50% or more, and that the usual prevention rate of the influenza vaccine is of 70%, the relatively low prevention effect of the AstraZeneca vaccine is unlikely to be a decisive obstacle to KFDA approval.

In this regard, AstraZeneca plans to submit additional data to the Ministry of Food and Drug Safety when phase 3 vaccine clinical trials are completed in the UK and Brazil. The test is scheduled to be completed in September. In other words, when the phase 3 clinical trial is not completed, the Ministry of Food Safety and Pharmaceuticals decides whether to approve the AstraZeneca vaccine.

There is also a review on the quality level of the vaccines produced by SK Bioscience. SK Bioscience sends the quality data of the vaccine submitted to AstraZeneca headquarters, UK, and based on the data, the headquarters performs an equivalence test with the vaccine used in the clinical trial. After that, AstraZeneca will send the general data to the Ministry of Food and Pharmaceutical Safety.

In preparation for the lengthy quality verification process, the Ministry of Food and Drug Safety announced that it plans to shorten the blanket approval review period by first reviewing quality data other than comparative data between manufacturing sites while the specifications are being prepared. related data.

Previously, the Ministry of Food and Drug Safety has been conducting a preliminary review of non-clinical data since October 6 last year after receiving a request from AstraZeneca, and a preliminary review of quality data has been conducted since on December 18 of last year.

In addition, the Ministry of Food and Pharmaceutical Safety announced that it aims to shorten the treatment period to more than 180 days and treat it within 40 days for rapid approval and detection of the AstraZeneca vaccine and Corona 19 vaccine and treatment.

The Food and Drug Safety Ministry stressed that it would closely review whether it is safe, as well as speed up the permit review. To this end, it announced that it would establish an advisory group of external experts to seek related advice and eventually receive advice from the Central Pharmacy Review Committee.