Novavax Expected to Be Approved Domestically This Month... "Providing Vaccination Opportunity for the Unvaccinated"

The Novavax COVID-19 vaccine, contract developed and manufactured (CDMO) by SK Bioscience, is displayed at the Ministry of Food and Drug Safety on the 17th. Photo by Lee Chunhee

[Asia Economy Reporter Lee Chun-hee] Novavax's COVID-19 vaccine, developed using a recombinant antigen method with fewer concerns about side effects, is expected to receive domestic approval within this month. The introduced vaccine is anticipated to be primarily used for unvaccinated individuals in South Korea.

Hong Jeong-ik, head of the Vaccination Management Team at the COVID-19 Vaccination Response Promotion Task Force, responded to inquiries about the target recipients of Novavax by stating, "The exact approval details need to be confirmed with the Ministry of Food and Drug Safety, but it is expected to be similar to foreign standards." He added, "Since the approval application is for the first and second doses, unvaccinated individuals are the target for vaccination." He further explained, "If someone chooses Novavax, which uses the recombinant antigen method, instead of the messenger RNA (mRNA) vaccines by this time, we are reviewing methods and locations to provide convenience for vaccination."

The Novavax COVID-19 vaccine was developed using a recombinant antigen method, unlike existing COVID-19 vaccines that use viral vector platforms (AstraZeneca, Janssen) or messenger RNA (mRNA) platforms (Pfizer, Moderna). Since this method has traditionally been used in various vaccines such as influenza, hepatitis B, and cervical cancer vaccines, it is understood that concerns about side effects from vaccination are low. According to the international scientific journal Nature, among the 50 recombinant antigen vaccines currently in clinical trials, none have shown side effects such as myocarditis, pericarditis, or thrombosis, which are representative side effects of existing COVID-19 vaccines.

The South Korean government signed a contract last year to receive 40 million doses of the Novavax COVID-19 vaccine. However, due to delays in approval by the U.S. Food and Drug Administration (FDA) and domestic authorization, all vaccine supplies have been postponed to this year.

Considering these characteristics, the authorities plan to focus vaccination efforts on unvaccinated individuals who have avoided vaccination due to concerns about side effects from existing vaccines. However, they emphasized that this measure differs from the past controversy over 'vaccine choice' during the initial vaccine introduction. Hong said, "Ultimately, it may appear as if people can choose between mRNA vaccines or the recombinant antigen Novavax vaccine," but he explained, "Rather than saying that vaccine choice is being allowed, please understand that among the remaining vaccines, the available option is limited to this."

AstraZeneca's COVID-19 Antibody Treatment 'Evusheld'
[Image Source=AP Yonhap News]

Meanwhile, with oral COVID-19 treatments expected to be introduced domestically next week, the government is reviewing related information not only on Pfizer's 'Paxlovid' and Merck (MSD)'s 'Molnupiravir,' which it has purchase contracts for, but also on AstraZeneca's antibody treatment 'Evusheld.'

Evusheld is an antibody treatment recently approved by the U.S. FDA. Laboratory-produced antibodies work by suppressing COVID-19 infection in the body for several months, providing both treatment and preventive effects. AstraZeneca announced that clinical trials showed Evusheld reduces the risk of COVID-19 infection by 77%.

Hong explained, "It has been approved in the U.S. for its role as a preventive agent, and we are currently reviewing its performance and advantages compared to vaccines," adding, "There are no concrete plans for its introduction yet."

This content was produced with the assistance of AI translation services.