Government Begins Reviewing the AstraZeneca Vaccine

[경향신문]

The Ministry of Food and Drug Safety launched a review of the novel coronavirus vaccine developed by AstraZeneca. The government plans to begin injecting the vaccine on high-risk hospital staff and senior citizens in collective living quarters, such as long-term care facilities, by the end of February.

On January 4, Jung Eun-kyeong, chief of the Korea Disease Control and Prevention Agency said, “We plan to begin (COVID-19) vaccination of high-risk groups, medical staff and senior citizens living in collective living facilities, such as long-term care hospitals and facilities, at the end of February,” and added, “We are currently identifying the list of people who will receive the vaccine and are making prior arrangements.”

The vaccine developed by AstraZeneca is expected to be the first COVID-19 vaccine to be injected in South Korea. This day, AstraZeneca Korea applied for the approval of the COVID-19 vaccine, AZD1222. The company requested an approval for the product that will be manufactured by SK Bioscience, a South Korean company, as well as an approval for imported products that will be manufactured overseas. The AstraZeneca vaccine will also be produced in the U.S., the U.K. and Italy.

However, the government plans to supply vaccines produced in South Korea for the vaccination of its people. Jung said, “As for the 20 million doses of the AstraZeneca vaccine--to vaccinate 10 million people--which will be supplied to South Korea, we have asked to receive products manufactured in South Korea, when possible.”

The Ministry of Food and Drug Safety announced that it would review the COVID-19 vaccine and conduct the lot release process as quickly as possible. The review for approval usually takes 180 days, but the ministry plans to finish the review within 40 days, and also carry out the lot release process, which usually takes 2-3 months, in twenty days.

The AstraZeneca COVID-19 vaccine is manufactured by adding the gene for the COVID-19 spike protein to a modified version of a chimpanzee adenovirus. The vaccine is for people aged eighteen or older, and is to be injected twice, 4-12 weeks apart. The vaccine can be refrigerated at 2-8 degrees Celsius, so distribution is easier compared to the vaccines by Pfizer and Moderna, which must be frozen.

AstraZeneca is currently conducting Phase 3 clinical trials in over ten countries including the U.K., Brazil and the U.S. The test is to evaluate the safety of the vaccine and is scheduled to end in September. The clinical test was suspended after problems occurred last September, but was resumed after a safety review showed that the problems had no direct relations with the vaccine.

According to the interim analysis of the Phase 3 clinical test released by AstraZeneca, the vaccine is on average 70.4% effective in preventing the virus. The World Health Organization (WHO) recommends vaccines should be at least 50% effective in preventing diseases. At present, the AstraZeneca vaccine has been approved in the U.K., India, Argentina, and El Salvador. The South Korean government has signed contracts to purchase COVID-19 vaccines for 56 million people including the AstraZeneca vaccine. The government will announce the specific vaccination plan within this month after discussions with relevant ministries.