Comparison to help speed up new domestic vaccine evaluations
Korean Covid-19 vaccines can now be evaluated through comparison with existing vaccines without having to go through clinical trials that require large control groups.
The Ministry of Food and Drug Safety released the “Plan for Covid-19 Vaccine Clinical Trial Standards" on Monday, which includes a comparative-style Phase 3 clinical trial in addition to the existing clinical trials.
The original Phase 3 clinical trials that vaccines have to go through normally require at least 10,000 test subjects.
But as Korea’s Covid-19 vaccination campaign picks up speed, domestic pharmaceutical companies have been having difficulty recruiting test subjects for comparing a placebo control group with an inoculation group, according to the ministry.
“With Korea’s Covid-19 vaccinations rolling out but still experiencing difficulty in recruiting placebo controlled subjects that have not been vaccinated, the existing method has become the biggest obstacle to the development of domestic vaccines,” the ministry wrote in its press release.
The ministry thus introduced a new design for its Phase 3 clinical trials, comparing the immunogenicity of the already authorized vaccine with the vaccine under development in order to prove the new vaccine's efficacy.
For example, if a newly developed Korean vaccine is to be compared to the already authorized Pfizer vaccine, its efficacy will be validated if the neutralizing antibody production rate in the people who got the trial vaccine is equal to or higher than those who received the Pfizer vaccine.
The new method allows companies to conduct Phase 3 clinical trials with only a few thousand subjects and without the need to recruit large-scale subjects and placebo controls.
The standard contains specific criteria such as for clinical study design, selection of comparative vaccine test subjects and evaluation variables.
The ministry still requires a minimum of 3,000 test subjects for safety assessment of variables such as side effects.
The Ministry of Food and Drug Safety said that five domestic pharmaceutical companies have entered clinical trials, and they have come up with ways to support the companies such as introducing comparative clinical trials for the commercialization of Korean vaccines.
The plan was based on an experience of participating in the World Health Organization (WHO) for vaccine review. The ministry also gathered opinions from domestic pharmaceutical companies and outside experts.
“In order for our vaccines, which are verified through comparative clinical trials, to be approved overseas, we will demonstrate the scientific validity of Phase 3 comparative clinical trials and the flexible application of regulations at the WHO conference and other international stages,” the ministry added.
BY SEO JI-EUN [firstname.lastname@example.org]