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| A researcher at SK Bioscience works on potential coronavirus vaccine at the company's manufacturing plant in Andong, North Gyeongsang Province, in this undated photo. Courtesy of SK Bioscience |
By Lee Hyo-jin
Korea is trying to speed up the domestic development of COVID-19 vaccines amid continuous global competition in procurement and concerns over the possible emergence of new virus variants.
Even though the government has secured an abundant supply of doses ― via contracts ― from various global pharmaceutical companies, some medical experts say the country should be prepared for other zoonotic diseases in the long term.
Oh Myoung-don, head of the country's central clinical committee for emerging diseases control, predicted that the coronavirus could become endemic, like influenza, which requires an annual vaccination program.
"We will have to live with the virus. Even if we eradicate COVID-19, the world may encounter COVID-21 or COVID-22 as similar zoonotic diseases originating from animals could reoccur in the future," Oh said during a press conference organized by the National Medical Center, May 3.
In this regard, calls are growing for the country to step up efforts to develop indigenous coronavirus vaccines.
According to the Ministry of Food and Drug Safety, so far, five domestic pharmaceutical companies ― SK Bioscience, EuBiologics, Cellid, Genexine, and Geneone Life Science ― have won approval to conduct clinical trials for candidate vaccines against the coronavirus.
SK Bioscience and EuBiologics are working on synthetic antigen vaccines, a technology used in the Novavax vaccine, which spurs an immune response in the recipient by injecting a spike protein from the coronavirus.
Cellid is developing a viral vector vaccine, such as those developed by AstraZeneca and Johnson & Johnson, while Genexine and Geneone Life Science are working on DNA vaccines.
As the five companies are currently conducting Phase 1 or 2 clinical trials, the health authorities expect one or two of them to proceed to Phase 3, the last step before seeking regulatory approval, as early as the end of the year.
This led to hopes that actual use of domestic vaccines will be viable from next year.
However, it will be challenging for the vaccine developers to carry out global Phase 3 clinical trials which require tens of thousands of volunteers. In the large-scale trial, one group is inoculated with the vaccine candidate, and the other group is administered a placebo, in order to assess the efficacy of the former.
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| People wait to receive a coronavirus vaccine at a public vaccination center in Seoul, May 3. Yonhap |
At this point of time when many countries have already rolled out nationwide vaccination programs, it will be difficult to recruit participants who are willing to receive investigational vaccines.
Facing such challenges, the government is seeking ways to reduce the number of volunteers needed in the development period.
The drug ministry is considering allowing firms to conduct comparative clinical trials, which will enable them to confirm the safety and efficacy of investigational drugs by comparing them with already developed vaccines, for instance, with AstraZeneca or Novavax.
Such a method was used in the development of a herpes zoster vaccine by SK Chemicals, the first of its kind to have won regulatory approval in the country in 2017.
Another option considered by the ministry is skipping the Phase 3 clinical trials, and replacing it with reviews on "immunological correlates of protection (ICP)."
An ICP is an indicator which can be used to indirectly evaluate a vaccine's efficacy. Through the indicator, researchers can examine the newly-developed drug's immunogenicity by comparing several indices such as antibody value and duration with those of other vaccines with proven efficacy.
Earlier in April, the government launched a task force on COVID-19 vaccine ICP protocols to come up with detailed guidelines. The task force includes experts from the Ministry of Health and Welfare, the Ministry of Science and ICT, the Korea Disease Control and Prevention Agency, the drug ministry, and the Ministry of Foreign Affairs.
The health ministry, for its part, said it has allocated 68 billion won ($61 million) to support domestic vaccine development and vowed to make every effort so that developers can launch Phase 3 clinical trials in the latter half of the year.
In the first half, the ministry plans to establish pre-arrangements for development such as procurement of standard materials, development of standard operation procedures and expansion of infrastructure for sample analysis.
In cooperation with other governmental bodies, the ministry will actively support the firms in recruiting participants for clinical trials, while building strategies on raw material supply chains via close government-private sector cooperation.
