S.Korea's GL Rapha certified to produce Sputnik COVID-19 vaccines

Moscow [Russia], October 26 : The Russian Direct Investment Fund, (RDIF, Russia's sovereign wealth fund) and GL Rapha, one of the leading South Korean bio-tech companies on Tuesday announced the issuance of a Russian GMP certificate by the Ministry of Industry and Trade of Russia for production of Sputnik family coronavirus vaccine in Korea.
This is the first time a foreign production partner of RDIF obtains a Russian GMP certificate, Sputnik V said in a statement.
Hankook Korus Pharm Co., Ltd. received the inspection from Russia's healthcare authorities earlier this year. South Korea is among the leading production hubs for the Russian vaccine. RDIF and GL Rapha have agreed to produce over 150 million doses per year of Sputnik V.
In total, the existing RDIF contracts with international partners enable the annual production of more than 1 billion doses of the Sputnik V and Sputnik Light vaccines per year outside of Russia.
Sputnik V is the world's first registered vaccine against COVID. It combines human adenovirus serotype 26 as the first component and human adenovirus serotype 5 as the second component. Heterologous boosting approach pioneered by Sputnik V has proven to be successful against coronavirus: the vaccine has confirmed overall efficacy 91.4% providing for creation of a strong and durable immunity. Sputnik V's efficacy against infection with the Delta variant is 83% and 94% against hospitalization. To date Sputnik V has been registered in 70 countries in various parts of the world with total population of over 4 billion people.
One-shot Sputnik Light is a highly effective vaccine when used both on standalone basis and applied as a booster. Sputnik Light has been authorized in more than 15 countries with the registration process ongoing in a further 30 countries.
The latest findings by the Gamaleya Center based on data from 28,000 subjects in Moscow have demonstrated the Sputnik Light vaccine administered standalone has 70% efficacy against infection from the Delta variant of coronavirus during the first three months after vaccination. The vaccine is 75% effective among subjects under the age of 60.
Efficacy of one-shot Sputnik Light as a booster against Delta variant for other vaccines will be close to the efficacy against the Delta variant of the Sputnik V vaccine: over 83% against infection and over 94% against hospitalization, the release said.
Sputnik Light has demonstrated a superior efficacy compared with some two-shot vaccines, which have shown a major decline in efficacy against the Delta variant to less than 50% five months after injection. Standalone use of Sputnik Light also provides much higher efficacy against severe disease and hospitalizations.
Clinical trials of a combination of vaccines with Sputnik Light used as a booster are ongoing in Russia, Argentina, Azerbaijan and UAE. In Argentina each "vaccine cocktail" combination with Sputnik Light provided higher antibody titer on 14th day after administering the second dose as compared to original homogenous (same vaccine as first and second dose) regimens of each of the vaccines thus confirming Sputnik Light is a great universal booster shot for other vaccines.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), commented: "Hankook Korus Pharm has become our first partner outside Russia to obtain a Russian GMP certificate meaning Company's facilities comply with industry's best standards. RDIF is expanding both production and export opportunities for Sputnik V and Sputnik Light to provide sufficient amounts of vaccines to partners around the world and partners in Korea are playing an important role in achieving this goal."
Whang Jae Gan, CEO of Hankook Korus Pharm Co, said: "It is our honor to be the first partner outside Russia to obtain the Russian GMP certificate for production Sputnik Vaccines. As the humanitarian perspective, our greatest goal is mass production and widespread use of Sputnik Vaccines in many countries. Through this valuable collaboration, I hope that Russia and South Korea will keep pace with each other in the field of biopharmaceuticals. Hankook Korus Pharm Co., Ltd. has already finished preparing commercial amounts of Sputnik Vaccines for the shipment."