92% effect’Sputnik Shock’… “Russian vaccine that was ridiculed, suddenly rises”

In recent years, major European Union (EU) countries such as France and Germany have made a move to introduce a novel coronavirus infection (Corona 19) vaccine developed by Russia and China. As the supply of Corona 19 vaccines in Europe started running and vaccinations stopped everywhere, they turned to Russia and China vaccines that had been neglected in the Western world.

The Washington Post on the 6th (local time) said, “As the EU’s vaccination plan is in jeopardy, Russia and China are about to make up for their shortcomings,” he said. “Russia went to talks to produce vaccines in the heart of Europe. Is trying to build a political reputation by providing vaccines competitively from outside Europe.” The Bloomberg news agency said, “The Russian vaccine that was ridiculed is rapidly emerging as a European savior.”

EU member states started vaccination at the end of last year, but the vaccination rate is not improving. According to The New York Times, the proportion of the population who received more than one vaccination in Spain was 4.3%, Italy 4%, Germany 3.8%, and France 2.9%. In contrast, the UK withdrew from the EU at 17.3% and the non-EU member Serbia at 7.7%. The UK is vaccinating the AstraZeneca vaccine and the Pfizer vaccine of the United States at the same time, and Serbia has introduced the Russian vaccine’Sputnik V’, which is not approved by the EU, and the vaccine from China’s Sinopam.

The biggest reason for the drop in vaccination rates in Europe is the lack of supply.

The amount of vaccines pre-purchased by the EU amounted to 1.5 billion doses, but the vaccine supplied to member states so far is about 12.9 million doses. EU Commissioner Urzula Ponderrayen said on the 4th that he overlooked that the supply of corona vaccine may not be smooth. “If Russian and Chinese manufacturers submit all data and show transparency, conditional sales approval (from the EU) You will be able to get it.”

Meanwhile, on the 2nd, the Gamaleya Center under the Ministry of Health of Russia published the results of phase 3 clinical trials of Sputnik V, a world-class medical journal, in the world’s medical journal Lancet, bringing the world to a’second Sputnik shock’. During the Cold War between the US and the Soviet Union, the Soviet Union launched the world’s first satellite Sputnik 1, which seemed to shock Western society in 60 years. According to the paper, a clinical trial was conducted in Russia from September 7th to November 24th, in which 11,868 people aged 18 and older participated, and the vaccine was effective at 91.6%. Of the 14,964 people who received the vaccine twice over 21 days, 16 (0.1%) were infected with Corona 19. Of the 4902 people who received the placebo (fake vaccine), 62 (1.3%) were infected. There were no serious patients or deaths in the vaccination group. There were no serious side effects. Four of the participants in the clinical trial died, but the research team analyzed that “it was confirmed to be unrelated to the vaccine.”

Sputnik V is a’viral vector’ vaccine. It is a vaccine that induces an immune response by inducing an antigenic protein in the body by injecting the Corona 19 antigen gene into another virus template (frame) such as adenovirus that is harmless to the human body. It is the same method as the AstraZeneca and Janssen vaccines scheduled for vaccination in Korea. Sputnik V can be stored refrigerated at 2 to 8 degrees Celsius when stored as a powder product, and liquids can be stored at -18 degrees Celsius for 6 months. Like Pfizer, transportation and storage are more convenient than vaccines that require distribution at -70 degrees Celsius.

Sputnik V became the world’s third COVID-19 vaccine with more than 90% effectiveness after Pfizer and Modena. Kim Woo-joo, a professor of infectious medicine at Korea University Guro Hospital, said, “We have been criticized for the hasty approval of President Putin even though there have been no results of Phase III. Professor Kim said, “It is uncertain whether the vaccine will be delivered as planned by the government, although the nations that have purchased the vaccine first will receive the vaccine first, and we will receive it later. There is a need. “Wouldn’t it be possible to build trust if we made our data by conducting clinical trials for Koreans even on a small scale while consigning production in Korea.”

However, experts point out that it is unreasonable to compare the performance in different vaccine clinical trials due to differences in the trial design method and implementation time and location. Ma Sang-hyuk, vice president of the Korean Society of Vaccine (Changwon Fatima Hospital, Department of Pediatrics and Adolescents), said, “It is difficult to compare 95% of Pfizer and 91.6% of Sputnik V just by number. “Be careful because it can vary depending on race and age distribution, and research and verification methods.” Vice Chairman Ma also pointed out that “the study ended last November, and the effect on the recently spreading mutant virus is unknown.”

Compared to Russian vaccines, Chinese vaccines have not yet received international evaluation, which is controversial. In China, three companies are developing vaccines, Sinoparm, Sinobac, and Kansino Biologics. The Chinese government approved the use of the Synopam vaccine in July last year and the Synobag earlier this year. The two vaccines are’inactivated vaccines’. It is a vaccine developed in a traditional way to induce an immune response by killing the virus and injecting it into the body as an antigen. It is the same method as the Japanese encephalitis vaccine and hepatitis A vaccine. If only the virus is secured, rapid development is possible and the manufacturing method is simple. There is also an advantage of excellent induction of neutralizing antibodies. However, as viruses are raw materials, production facilities with high biosafety levels are required. Serbia has already been vaccinated with the sinofam vaccine, and Hungary and Mexico have also approved its use. Sinoparm claimed that its vaccine was 79% effective. In the case of Synobac, the prevention effect was 91% and 65.3% in Turkey and Indonesia, respectively, and 50.38% in Brazil. Until now, no papers containing the results of phase 3 clinical trials have been published, raising questions about the effectiveness and safety.

The Korean government has been closely watching the stages of vaccine development in Russia and China, but said it has no plans to introduce them yet. Yang Dong-gyo, head of the Korea Centers for Disease Control and Prevention, explained at a briefing on the 4th that “there is no discussion for an introduction contract with respect to Sputnik V vaccine.” Earlier on December 31, last year, President Eun-Kyung Chung of the Sinofam vaccine said, “The current vaccine prevention effect has been suggested by the World Health Organization (WHO) and the US Food and Drug Administration (FDA) based on the prevention effect of more than 50%.” He said, “It will be difficult for me to personally evaluate how the 79% prevention effect of (Sinopharm) is.”

However, the government has said it is monitoring China’s vaccine development through diplomatic channels. Im In-taek, director of health industry policy at the Ministry of Health and Welfare, announced the government’s plan to introduce a vaccine last September. “Adverse reactions are evaluated as being very low and effective.” “The vaccine is being confirmed through the Ministry of Food and Drug Safety. If it is determined that it is good, we plan to operate a consultation channel so that users can purchase in advance.”
Reporter Esther and Hwang Soo-yeon [email protected]