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Opinion
[Reporter's view] COVID-19 vaccination strategy
by Aug 09, 2022 05:56am
The MFDS has begun a preliminary review of the vaccine for COVID-19 in Moderna and Pfizer. The preliminary review is to review the submitted clinical data in advance and to quickly determine whether to grant permission when the company applies for an item permit by adding non-clinical and quality data in the future. The divalent vaccine, which Moderna and Pfizer applied for a preliminary review, is a vaccine that expresses each antigen for the initial coronavirus (Wuhan) and the omicron mutation virus BA. It is a combo vaccine that combines two antigens in half, and the two companies began developing it early this year and announced major clinical results in June. The two vaccines were found to have produced more neutralizing antibodies to omicron mutations than conventional vaccines. The problem is that BA.5, an omicron subvariant, spread rapidly and became dominant in Korea. According to the detection rate of major mutant viruses compiled by the Korea Centers for Disease Control and Prevention, the BA.5 detection rate in the fourth week of July was 66.8%, up 10.5 percentage points from the previous week. It became the dominant species 11 weeks after the first BA.5 stool confirmed in Korea on May 12. Modena and Pfizer's divalent vaccine basically expresses antigens against the circular omicron virus, so it has a higher preventive effect on sub-variations than conventional vaccines. However, it was relatively ineffective as it targeted BA.1. According to the announcement of the two companies, the neutralization value of the bivalent vaccine for BA.4/5 was one-third of the number shown in the BA.1 mutation. That's why the FDA has demanded that Moderna and Pfizer develop a new vaccine containing BA.4/5 which is included. At that time, sub-variations were spreading rapidly in the United States, so the FDA seems to have decided that it was necessary to target these mutations. The two companies are focusing their efforts on developing a new vaccine targeting submutation of omicron. South Korea should also consider what vaccination strategy to establish at a time when the omicron submutation has become the dominant species. The FDA is showing its willingness to inoculate vaccines targeting submutations even while minimizing clinical trials of the new vaccine. If there are more BA5 confirmed patients in Korea, the introduction of a BA4/5 vaccine should be accelerated. At the same time, there are differences between the U.S. and Korea. The United States, the mainland, spends the least time getting permits and vaccines. The U.S. health authorities have already signed a purchase contract for the BA.4/5 vaccine with Moderna and Pfizer. On the other hand, South Korea has relatively late permits, contracts, and domestic introduction schedules. A situation beyond the end of this year may occur. Unlike the United States, which has not been approved for a divalent vaccine, Korea needs to have an alternative solution called a divalent vaccine for omicrons. Health authorities should benefit the public most through reasonable choices within limited time and resources.