Dr. N. Sriram et al / Int. J. of Allied Med. Sci. and C lin. Research Vol-9(1) 2021 [ 1-10] International Journal of Allied Medical Sciences and Clinical Research (IJAMSCR) ISSN: 2347 -6567 IJAMSCR |Volume 9 | Issue 1 | Jan - Mar - 2021 www.ijamscr.com Review article Medical research Development of new covid -19 vaccines from india : A systematic review 1Dr. N. Sriram, 2S. Kameshwaran , 3Asokkumar DS , 4N. Elavarasan, 5M. Sarbudeen 1Department of Pharmaceutics, Hits College of Pharmacy, Bogaram, Ghatkesar, Hyderabad, Telangana, India 2-5 Excel college of Pharmacy, Komarapalayam, Namakkal, Tamilnadu – 637303. *Corresponding Author :Dr. N. Sriram email: [email protected] ABSTRACT Extreme acute respiratory syndrome Coronavirus 2 (SARS -CoV-2) is an extremely pathogenic new virus that has triggered the current worldwide coronavirus disease pandemic (COVID -19). Currently, substantial effort has been made to produce successful and safe medicines and SARS-CoV-2 vaccines. To avoid more morbidity and death, a successful vaccine is important. Though some regions which deploy COVID -19 vaccines on the basis of protection and immunogenicity data alone, the aim of vaccine research is to obtain d irect proof of vaccine effectiveness in protecting humans against SARS-CoV -2 and COVID-19 infections in order to selectively increase the production of effective vaccines. A SARS-CoV-2 candidate vaccine can function against infection, illness, or transmiss ion and a vaccine that is capable of minimising all of these components may lead to disease control. In this study, we discussed the Bharat Biotech and Covishield Serum Institute of India's Covaxin - India's First Indigenous Covid -19 Vaccine. Keywords: Cova xin, Covishield, SARS -CoV-2, COVID-19, Serum Institute, Bharat Biotech. INTRODUCTION been confirmed as of 26 January 2020, most of which included individuals living in or visiting According to the WHO, multiple cases of Wuhan, and human-to-human transmission has pneumonia of unknown aetiology were found in the been confirmed [1]. city of Wuhan in central China in December 2019. Most of the initial affected individuals is In Wuhan, China, patients who had viral associated w ith exposure to the seafood industry pneumonia due to an unknown microbial agent [2]. In 2020, 2835 confirmed cases were reported were documented at the end of Dece mber 2019. A by the Chinese authorities in mainland China, novel coronavirus, provisionally named the 2019 including 81 deaths. Furthermore, in Hong Kong, novel coronavirus (2019-nCoV), was subsequently Macao and Taiwan, 19 confirmed cases were identified as the causative pathogen. The quickly reported and 39 imported cases we re identified in circulating coronavirus disease was declared by Thailand, Japan, South Korea, the United States, WHO on February 11th 2020 as COVID -19. More Vietnam, Singapore, Nepal, France, Australia and than 2000 incidents of COVID-19 infection have 1 Dr. N. Sriram et al / Int. J. of Allied Med. Sci. and Clin. Research Vol-9(1) 2021 [1-10] Canada. COVID-19, which is closely linked to COVAXIN extreme acute respiratory syndrome CoV (SARS- CoV), was quickly identified as the pathogen [3]. BBV152 (also known as Covaxin) is a COVID- A novel coronavirus, 2019-n CoV, as the 19 inactivated virus-based vaccine developed in causative agent, has officially been announced by partnership with the Indian Council of Medical the Chinese authorities [4, 5]. Coronaviruses (CoV) Research by Bharat Biotech. Covaxin, India's first are a family of viruses called Coronaviridae. There indigenous COVID-19 vaccine, is the first are three genera in the subfamily Coronavirinae: indigenous COVID-19 vaccine developed by alphacoronavirus, betacoronavirus, and gamma- Bharat Biotech in partnership with the Indian coronavirus. Two genera, torovirus and bafinivirus, Council of Medical Research (ICMR) - National are in the subfamily Torovirinae. CoV can lead to a Institute of Virology (NIV). The indigenous, number of symptoms as mild as common cold, inactivated vaccine is produced and processed in fever and cough, and as severe as pneumonia, the high containment facility of Bharat Biotech's kidney failure or even death in respiratory distress BSL-3 (Bio-Safety Level 3). The vaccine earned [6]. These viruses are zoonotic, that is, spread DCGI clearance for Phase I & II Human Clinical between animals and humans. A few coronaviruses Trials, and studies started in July 2020 across India. were previously recognised: MERS-CoV, which Bharat Biotech obtained DCGI clearance for Phase causes respiratory syndrome in the Middle East and 3 clinical trials in 26,000 participants in over 25 was transmitted to humans from dromedary camels, centres across India after successful completion of and SARS-CoV, which causes extreme acute the interim review of the Phase 1 & 2 clinical trials respiratory syndrome and was transmitted to of Covaxin [12, 13]. humans from civet cats [7, 8]. In a wet market in The National Institute of Virology of the Indian Wuhan where game animals and beef were sold, Council of Medical Research (ICMR) accepted and COVID-19 is believed to have been zoonotically supplied the virus strains in May 2020 for the transmitted [9]. production of a fully indigenous COVID-19 Popular human coronaviruses, such as types vaccine.[14, 15] In June 2020, the company was 229E, NL63, OC43 and HKU1, however, cause approved by the Drugs Controller General of India mild to severe symptoms of the upper respiratory (DCGI), Government of India, to perform Phase 1 tract, sore throat, runny nose and cough. Other and Phase 2 human trials of a developmental symptoms are fever, headache, and feeling unwell COVID-19 vaccine called Covaxin.[16] A total of in general. In people with cardiopulmonary 12 sites were chosen by the Indian Council for disorders, immuno compromised patients, children, Medical Research for Phase I and II randomised, and older adults, more serious conditions affecting double-blind and placebo-controlled vaccine the lower respiratory tract, such as pneumonia and candidate clinical trials.[17, 18] The company bronchitis, are more frequent. Via coughing or announced the study for Phase I trials in December sneezing or near physical contact such as rubbing 2020 and presented the findings via medRxiv or shaking hands, these viruses are transferred from preprint.[20-22] infected humans to others through air [10]. In November 2020, after completion of Phase I A total of 94,962,048 confirmed cases in the and II, Covaxin was authorised to perform Phase III country, spread in 81 countries, resulting in the clinical trials[23, 24] The study involves a epidemic of COVID-19, of which 2,031,142 died. randomised, double-blinded, placebo-controlled Of the total cases, the United States of America has study among volunteers aged 18 and above and the highest number, with 24,306,043 cases, began [25] Approximately 26,000 volunteers from followed by 10,558,710 in India, 8,456,705 in across India will be involved in the Phase III Brazil, 3,544,623 in Russia, 3,357,361 in the trials.[26] The phase III trials will cover a total of United Kingdom, 2,894,347 in France, etc [11]. His 26,000 volunteers from across India [27] The study article deals with the Covid-19 preventive rejection rate for Phase III trials was far higher than vaccine manufactured in India. for Phase I and Phase II trials. As a result, by 22 December, only 13,000 volunteers were employed, with the figure rising to 23,000 by 5 January [28- 30] 2 Dr. N. Sriram et al / Int. J. of Allied Med. Sci. and Clin. Research Vol-9(1) 2021 [1-10] On its vero cell manufacturing platform [31] The DCGI released a statement on January 3, that has the potential to deliver around 300 million 2020, noting that Covaxin was "developed on Vero doses, Bharat Biotech produces the vaccine cell platform, which has well established track candidate through at-risk manufacturing [32] The record of safety and efficacy in the country and company is in the process of setting up a second globally" The DCGI said that Bharat Biotech, plant to make Covaxin at its Genome Valley maker of Covaxin, shared its "safety and facility in Hyderabad. For another place in the immunogenicity data" from its animal studies, country to produce the vaccine, the company is in including "challenge studies on non-human talks with other state governments including primates (Rhesus macaques) and hamsters" with Odisha [33]. Besides this, global tie-ups for the the CSDSCO drug regulator. The DCGI has shown development of Covaxin are also being "demonstrated that the vaccine is safe and provides explored.[34] In December 2020, OcugenInc a robust immune response" in phase I and phase II entered into a collaboration with Bharat Biotech to with respect to clinical human trials. The drug co-develop Covaxin for the U.S. market.[35, 36]. In regulator said, citing phase III results from around January 2021, Precisa Med entered into an 22,500 patients, "The vaccine has been found to be arrangement to supply Covaxin in Brazil with safe as per the data available till date." The Bharat Biotech [37] CSDSCO's Topic Expert Committee (SEC) Bharat Biotech applied for an emergency use checked the Covaxin safety and immunogenicity authorization (EUA) from the Drugs Controller data, the DCGI said, before recommending General of India (DCGI), Government of India.[38] authorization for restricted use of this Covid-19 After Serum Institute of India and Pfizer, it was the vaccine in emergency circumstances [13]. third company to apply for emergency use In the past, there have been many examples approval.[39]. On 2 January 2021, an EUA permit where the Indian drug regulator issued emergency was recommended by the Central Drugs Quality permission based solely on evidence on Control Organisation (CDSCO) [40], which was immunogenicity.