South Korea granted its first approval of a COVID-19 vaccine to AstraZeneca, allowing the two-shot regimen to be administered to all adults, including the elderly, officials announced Wednesday. Photo by Thomas Maresca/UPI | License Photo
SEOUL, Feb. 10 (UPI) -- South Korea granted its first approval of a COVID-19 vaccine to AstraZeneca, allowing the two-shot regimen to be administered to all adults, including the elderly, the country's Ministry of Food and Drug Safety announced Wednesday.
The vaccine, developed by the British-Swedish pharmaceutical giant and Oxford University, is being manufactured in South Korea by contract with local firm SK Bioscience.
The approval came with a warning, however, that consideration is needed when administering the vaccine to individuals over age 65 due to limited data from that demographic in clinical trials.
"Approval has been granted but we wanted to include language that physicians should carefully consider the benefits and risks when administering [the vaccine] to those over the age of 65," Vice Health Minister Kim Gang-lip said at a press conference Wednesday.
The vaccine has been approved for use in the European Union by the European Medicines Agency but some countries, including France and Germany, are limiting it to adults age 18-64 due to insufficient data on its efficacy. A South Korean advisory panel earlier this week also urged caution over its use among the elderly.
"There was no controversy or arguments over the safety of the vaccine for those aged over 65," Kim said. "But there is a lack of sufficient clinical trial data."
Only around 8% of subjects in clinical trials in Britain and Brazil were over 65, Kim said.
South Korea's approval of the vaccine was granted on the condition of receiving the results of ongoing clinical trials, including a 30,000-patient late-stage trial in the United States that includes around 7,500 older adults. Kim said South Korea expects to receive initial results from the U.S. trial in April.
The efficacy of the AstraZeneca vaccine and its optimal dosing regimen have been a source of some public confusion.
Results of trials in Britain and Brazil indicated a 62% effectiveness. However, a preliminary study printed in The Lancet earlier this month found that a single dose proved 76% effective, and if the second dose is delayed for 12 weeks, efficacy rises to 82%.
South Korea has also struck deals with Pfizer, Moderna and Johnson & Johnson for vaccines and will receive additional doses through the COVAX Facility, a global alliance of governments and manufacturers. Altogether, the country has secured more than enough doses to inoculate its entire population of 52 million.
South Korea's first vaccinations are scheduled to begin on Feb. 26, the Korea Disease Control and Prevention agency announced on Tuesday. Front-line health workers and the elderly in nursing homes will be among the first groups to be inoculated, with a phased rollout that is expected to reach the general public in the third quarter. The country is aiming for herd immunity by November.
Health authorities have been trying to contain a third wave of the COVID-19 pandemic, which has been spreading since mid-November. Daily cases reached a high of 1,241 on Dec. 25 but have steadily declined since, hitting a two-month low of 289 cases of Monday.
Cases rose again to 444 on Wednesday, and health officials have expressed caution about a further outbreak over the coming Lunar New Year holidays, which begin on Thursday.
The approval of the AstraZeneca vaccine will give a much needed boost to South Korea's efforts to contain the virus, Kim said Wednesday.
"Hopefully with this approval, our response going forward will be energized," he said.