[Press Release, April 29, 2021 / Unofficial Translation]

□ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) has announced that Huons Co., Ltd. filed for rolling review of Russia’s Sputnik V COVID-19 vaccine on April 29 prior to submitting an application for marketing authorization.

○ Since Sputnik V is not included in the Korean government’s COVID-19 vaccination program, Huons has filed for rolling review of the non-clinical data (toxicity and efficacy tests) in accordance with Pharmaceutical Affairs Act.

○ The MFDS will rigorously review the safety and efficacy of the vaccine, based on the submitted non-clinical data.

○ Sputnik V is a viral vector vaccine which has been authorized in 61 countries including Russia, but not in the U.S. and the E.U.
- The vaccine is currently under the European Medicines Agency (EMA)’s rolling review and the WHO Emergency Use Listing (EUL) evaluation.
* The EMA’s rolling review: since March 4, 2021 The WHO EUL evaluation: since October 2020

□ The MFDS will spare no effort for a timely provision of safe and effective vaccines.