SEOUL, Feb. 23 (Korea Bizwire) — South Korea’s drug safety agency on Wednesday authorized the use of global pharmaceutical giant Pfizer Inc.’s COVID-19 vaccine for children aged between 5 and 11.
The Ministry of Food and Drug Safety convened a panel of experts from both inside and outside to review the safety and efficacy of the two-dose regimen, after reviewing Pfizer’s clinical studies.
It marks the first time for the agency to authorize the use of COVID-19 vaccines for young children.
The ministry said the vaccine was found to be 90.7 percent effective in preventing COVID-19 in children aged 5 through 11.
Also, safety was studied in 3,109 children aged between 5 and 11 who were administered with the vaccine, and no serious side effects have been reported.
The side effects observed in the studies were usually mild or moderate, with some reports of red marks, the ministry said.
Side effects were reported more frequently during the first shots compared with the second shots, but they were mostly gone within three days.
The Pfizer vaccine is administered as a two-dose primary series with a three-week interval period.
Children with their immunity significantly compromised can get a booster shot four weeks later, officials said.
It is a lower dose of 10 micrograms than the one used for individuals aged 12 years and older, which has a dose of 30 micrograms.
The decision comes at a pivotal moment in the country’s COVID-19 pandemic wave as the highly contagious omicron variant has become the dominant strain and schools are to reopen early next month.
Health authorities said they will announce a detailed inoculation schedule of Pfizer vaccines for children next month.
Health experts forecast older children with underlying diseases will be the priority group.
“Children with obesity and other kinds of underlying diseases, such as chronic lung-related diseases, heart diseases and diabetes will be advised for the priority group for inoculation as they have high possibility of developing into severe cases when infected,” said Choi Eun-hwa, a pediatrics professor at Seoul National University Hospital.
On Wednesday, the country reported 171,452 new COVID-19 infections to hit another high, as the highly contagious omicron variant continued to spread across the country.