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  • Comparing Cellid with Janssen¡¤AZ¡¦ SK Bio with Novavax
  • by Lee, Tak-Sun | translator Alice Kang | Jun 1, 2021 06:11am
allowed as Phase III comparative effectiveness clinical trials to support the development of domestic vaccines
Neutralizing antibody of the two vaccines to be compared at week 4 after vaccination
A minimum of 4,000 subjects are required for safety evaluation
Multinational clinical trials with 10% or higher proportion of Korean subjects also allowed
With the Ministry of Food and Drug Safety announcing lowered standards for conducting Phase III clinical trials to promote the development of domestically developed COVID-19 vaccines, commercialization of Korean COVID-19 vaccines is likely to happen sooner than expected.

In particular, domestic vaccines that were not able to enter the Phase III stage may be able to enter the market early by conducting comparative effectiveness clinical trials with previously approved products.

On the 31st, the MFDS released the ¡°Standard Draft for Covid-19 Vaccine Clinical Investigation Plans" on the 31st. In particular, the draft allows comparative clinical trials (phase 3) with previously approved vaccines.

On the 31st,
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