On the 7th, citizens are waiting for tests at the COVID-19 screening clinic at Songpa-gu Public Health Center in Seoul. The Central Disaster and Safety Countermeasures Headquarters announced that as of midnight, there were 105,507 new confirmed cases. The number of confirmed cases has exceeded 100,000 for six consecutive days. Photo by Moon Honam munonam@
[Asia Economy Reporter Lee Chun-hee] As the Omicron COVID-19 variant spreads and the resurgence intensifies, the number of new COVID-19 cases reached 105,507 on the 7th, marking the highest Sunday count in 17 weeks. In response, pharmaceutical companies that developed the original COVID-19 vaccines are now working on vaccines targeting Omicron.
Pfizer and Moderna, developers of the messenger RNA (mRNA) vaccines that have dominated the COVID-19 vaccine market, have already developed vaccines targeting the Omicron variant BA.1 and are undergoing global approval processes. Domestically, procedures for the approval of Omicron-targeting vaccines are also underway. On the 5th, the Ministry of Food and Drug Safety announced that it had begun a preliminary review of Pfizer's COVID-19 vaccine 'Comirnaty 2-dose 0.1 mg/mL,' developed to target Omicron BA.1. This was in response to a preliminary review application submitted by Korea Pfizer Pharmaceutical.
This vaccine is a multivalent vaccine expressing antigens for both the original COVID-19 virus strain 'Wuhan strain' and the Omicron BA.1 variant. It is developed as a booster dose for individuals who have completed the primary series of vaccination using the same messenger RNA (mRNA) method as the original Pfizer vaccine. Preliminary review procedures are underway in Europe and other regions, and in the United States, an additional supply contract for 105 million doses of this vaccine was signed in June.
The Ministry of Food and Drug Safety is also reviewing Moderna's Omicron-targeting vaccine 'Moderna Spikevax 2-dose (mRNA-1273.214)' for approval. Following Moderna's preliminary review application to the Ministry on the 20th of last month and the subsequent application for import and sales approval on the 29th, related procedures are in progress. This is also a multivalent mRNA vaccine expressing antigens for both the Wuhan strain and Omicron BA.1. The vaccination method is the same, serving as a booster after the primary vaccination series.
According to Moderna, production of Moderna Spikevax 2-dose has already started at Samsung Biologics, which currently manufactures the original 'Spikevax' finished product (DP). Since production is already underway, it is expected that supply can begin next month once approval is granted.
However, these vaccines were all developed only to target the initial Omicron variant BA.1. They are not vaccines developed to target the BA.4 and BA.5 variants, which currently pose the greatest threat domestically and internationally. In fact, both Pfizer and Moderna vaccines have shown strong neutralizing antibody responses against BA.1, but responses against BA.4 and BA.5 are known to be about three times lower. Accordingly, the U.S. Food and Drug Administration (FDA) has recommended including BA.4 and BA.5 variant antigens in COVID-19 booster vaccines to be used in the second half of the year, but additional development is expected to take some time.
Domestically, Cellid is developing an Omicron variant vaccine called 'AdCLD-CoV19-1 OMI.' On the 4th, it received approval from the Ministry of Food and Drug Safety for its phase 1 and 2 clinical trial plans. This is a viral vector vaccine manufactured by inserting the surface antigen gene of the COVID-19 Omicron variant virus into an adenovirus vector. Through phases 1 and 2 clinical trials, the plan is to evaluate safety and immunogenicity, including how much neutralizing antibodies that can neutralize the virus increase.
The clinical trials will be conducted as a single booster dose administered to individuals who have completed the primary COVID-19 vaccination series or those who have been released from isolation after COVID-19 infection.
The Ministry explained that it approved the clinical trial plan because non-clinical trial data submitted by Cellid confirmed the generation of neutralizing antibodies against the Omicron antigen in experimental mice and monkeys vaccinated with the vaccine, indicating readiness for clinical entry.
SK Bioscience's domestically developed COVID-19 vaccine 'Skycovione Multi-dose' has also been confirmed to be effective against the Omicron variant when used as a booster. An extended study of phases 1 and 2 clinical trials analyzed the cross-neutralizing ability of the booster dose and confirmed an immune response against BA.1. In a study involving 81 healthy adults, approximately seven months after completing the two-dose primary series of Skycovione, an additional booster dose of Skycovione was administered. The neutralizing antibody titer capable of neutralizing the infectivity of the Omicron variant and inducing preventive effects increased about 25-fold compared to immediately after the second dose. Compared to the time just before the booster dose at around seven months after the second dose, it was about 72-fold higher.
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