The Ministry of Food and Drug Safety said that it has begun a preliminary review of Comirnaty, Pfizer’s Covid-19 vaccine developed to fight the Omicron variant.
Pfizer Korea applied to the ministry on Friday for a preliminary review on clinical trial data of the Omicron-targeting Comirnaty vaccine.
The messenger RNA (mRNA)-based vaccine expresses antigens both for the Wuhan strain, the initial Covid-19 virus, and Omicron strain (BA.1), a Covid-19 variant.
Pfizer developed the vaccine as a booster shot after primary vaccination with the existing vaccines.
The drug regulator stressed that it plans to review the submitted clinical data promptly and carefully, and will conduct an additional review and take advice from experts on the safety and efficacy of the booster vaccine when Pfizer applies for product approval by submitting additional non-clinical and quality data.
The ministry’s review comes as Korea's daily Covid-19 tally exceeded 100,000 for the fourth straight day on Friday.
The KDCA confirmed 112,901 new virus cases raising the cumulative caseload to 20,273,011 on Friday. An additional 47 people died of Covid-19, raising the death toll to 25,191, with a fatality rate of 0.12 percent.
The nation also continued to see an increase in the number of critically ill patients with 320, up 10 from the previous day.
With the BA.5, an Omicron subvariant, now established as the dominant strain in Korea, health authorities again urged high-risk groups to receive the second booster shot.
“As BA.5 evades immunity, an increase in reinfection is unavoidable,” Covid-19 Response Headquarters head Jung Ki-suck said during a daily briefing on Friday. “As long as subvariants continue to emerge, the reinfection rate will inevitably rise for some time.”
Studies showed that reinfection in high-risk groups is particularly dangerous and it is important for those included in the group to receive a second booster shot, Jung emphasized.
Still, only about 45 percent of people aged over 60 received a second booster shot.
Health experts criticized the Yoon administration’s quarantine policies.
The government had previously stated that it will promote a “targeted quarantine,” which aims to intensively manage only venues with a high risk of infection.
However, some health experts pointed out that the government only changed the policy name from “scientific quarantine” without effective measures. They urged the government to take actions rather than try to assure the public.
“It seems that the government is not acting on certain quarantine measures that they need be implementing,” said Paik Soon-young, an emeritus professor of microbiology at the Catholic University of Korea, to Yonhap News Agency, the state-run wire service. “Strengthening the polymerase chain reaction (PCR) test for travelers and expanding the PCR test for close contacts is something that health authorities could and should do during the current situation.”
Paik also criticized targeted quarantine as a play of words, saying that the management of high-risk groups was an existing method.
Professor Choi Jae-wook at the Department of Preventative Medicine of Korea University College of Medicine also agreed.
“It seems that the government has insufficient measures to make people participate more actively in its self-quarantine system,” Choi said. “They will have to come up with incentives or support policies for more active participation from the public.”
Choi emphasized the need to communicate more effectively with the public so that Korea can be prepared in the event of another epidemic.