Even before the third phase of the clinical trial ends … India approves the vaccine against the national crown ‘Kovaxin’: Dong-A Science

Russia’s ‘Putnik V’ and Sinopam Intermediate Vaccine Also ‘Pre-Approved, Post-Phase 3’

As countries around the world are accelerating vaccination for new coronavirus infections (COVID-19, Corona 19), a growing number of countries are granting emergency use approval for vaccines developed in their own country. On the 3rd (local time), the Indian government approved the emergency use of the Corona 19 ‘Covaxin’ vaccine, which is being developed by the local pharmaceutical company Barat Biotech. Earlier, China approved a vaccine from the Chinese pharmaceutical company Sinopharm on the 31st, the last day of last year.

● Corona 19 vaccine selected as a case of ‘independent delivery’

According to Indian media such as The Hindu and Times of India, Kovacin is India’s first national vaccine developed by Barat Biotech in collaboration with the Indian Council for Medical Research (ICMR) and the National Institute for Virus Research.

The Drug Administration of India (DCGI) held a press conference on the 3rd and said: “Barat Biotech vaccine provides a safe and strong immune response” and “approved for limited use in emergency situations”. On that day, DCGI also approved Covishield, a British AstraZeneca vaccine produced by the Serum Institute (SII), a local vaccine company in India, along with Cobaxine.

Cobaxin is an inactivated vaccine made by weakening the virulence of the virus. Barat Biotech explained that many existing vaccines, such as hepatitis A, influenza and polio, are inactivated vaccines and have excellent safety, in addition to generating an immune response.

In a preclinical trial (animal trial) performed with 20 rhesus monkeys, a strong immune response was formed as a result of the experiment divided into 4 groups. In phases 1 and 2, clinical trials were conducted in 800 children, including children, using the double-blind method. The test was performed to confirm the effect of antibody formation. The 22,500-person phase 3 clinical trial is currently underway and approval for rush use has waned, while final results have not been disclosed.

The Central Medical Standards Committee (CDSCO) of India, which conducted a vaccine license review by an agency under DCGI, said: “Cobaxin is 110% safe and if side effects occur we will follow up immediately “.

Indian Prime Minister Narendra Modi said: “The fact that both vaccines approved for emergency use are manufactured in India will make all Indians proud.” “It shows the aspiration of our scientific community to realize the dream of ‘Atmanirbhar Bharat.’ Said.

Independent India is assessed as the world’s largest exporter of generic drugs as it is already known as the ‘pharmaceutical hub’ of world pharmacies in the pharmaceutical industry with the Indian government’s policy of becoming a global manufacturing hub. In the case of hydrochloroquine, an antimalarial drug that was misrepresented as having an early effect in the corona 19 epidemic last year, India produces 70% of the world’s supply.

● China approves Sinopharm on the last day of 2020

On the 31st of last month, China approved the use of the Corona 19 vaccine by its own pharmaceutical company Sinoparm (a Chinese pharmaceutical group). In China, in addition to Sinoparm, five vaccines under development in their home countries, including Sinobac and the Chinese Academy of Sciences, are in phase 3 clinical trials. Of these, Sinoparm obtained emergency approval for use first. place.

China’s National Drug Administration stated the reason for the approval, saying: “The sinopam vaccine is safe and meets the standard technical conditions of the World Health Organization (WHO).” Instead, you are conditioned to continue to monitor and report immune persistence and preventive effects through phase 3 clinical trials.

Synofam vaccine is an inactivated vaccine made by weakening the virulence of the virus, such as cobaxin in India. The day before approval, Synofarm revealed that the efficacy of its Corona 19 vaccine was 79.34%, and that minor side effects such as mild fever were seen in 0.1% of clinical participants in Phase III. The Chinese government began vaccination in the capital, Beijing and Shandong provinces from 1 this month, a day after the synopal vaccine was approved. Meanwhile, the United Arab Emirates and Bahrain approved the use of the sinofam vaccine on the 9th and 13th of last month, respectively, before the Chinese government.

In August last year, Russia approved the emergency use approval of the world’s first domestic vaccine, Sputnik V. However, Russian health authorities have been criticized around the world for approving the Sputnik V vaccine in combined clinical trials of phase 1 and 2, only 28 people have been tested.

The Sputnik V vaccine is currently in a phase 3 clinical trial, and the vaccine developer, the Gamaleya National Center for Infectious Diseases and Microbiology, under the Russian Ministry of Health, published a press release on the 14th of the month. passed and conducted a phase 3 clinical trial in 22,714 people. Interim results were released, saying that the efficacy was 91.4% 21 days after the single vaccination. The phase 3 clinical trial of Sputnik V will be carried out in a total of 40,000 patients in May of this year.

● Phase 3 clinical approval, safety controversy

All three vaccines developed by global pharmaceutical companies Pfizer, German Bioentech, Modena, and AstraZeneca, have been approved for emergency use after completing phase 3 clinical trials so far. Among them, the AstraZeneca vaccine has not yet been approved by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and only the approval of the Medicines and Healthcare Products Regulatory Authority has fallen. of the United Kingdom (MHRA).

Vaccines that have been developed and approved in Korea, including covacin from India, have been approved for emergency use before the completion of the phase 3 clinical trial, raising controversy over safety. According to Reuters, when Kobaksin was approved, Indian industry experts and the opposition party launched an offensive that could not be trusted, saying they did not disclose the effects of Kobaksin in detail. Reuters, citing sources, said that the preventive effect of covacin was more than 60% after two doses were completed. This is somewhat lower than the efficacy of the Pfizer and Modena vaccine, which is over 90%.