India’s regulatory authority granted a restricted emergency approval to two COVID-19 vaccines in India on January 3rd, 2021. The first of these was a recombinant chimpanzee adenovirus vector vaccine (ChAdOx1 nCoV-19). The second approved vaccine was an indigenously developed whole virion inactivated coronavirus vaccine (BBV152).
Oxford/AZ- ChAdOx1 nCoV-19, marketed as COVISHIELD, has been manufactured by Serum Institute of India (SII) under the expert foundation laid by Oxford University and Astra Zeneca. Even before its emergency approval, more than 40 million doses of the vaccine had already been manufactured by the SII under the at-risk manufacturing and stockpiling license from the DCGI. A pooled analysis of phase 2/3 trials conducted in over 20,000 participants from the UK, Brazil, and South Africa showed that the ChAdOx1 nCoV-19 vaccine had an acceptable safety and immunogenicity profile with efficacy against symptomatic COVID-19. To establish the safety, efficacy, and immunogenicity of COVISHIELD in India, SII together with the Indian Council of Medical Research (ICMR) came forth to conduct a phase II/III clinical trial at 15 different centers across India. Interim safety and immunogenicity data obtained from this trial were comparable to the data from an overseas clinical trial conducted with COVISHIELD. Considering the above data, the Subject Expert Committee of Central Drugs Standard Control Organization (CDSCO), India after due consideration and detailed contemplation, recommended that COVISHIELD be granted permission for restricted use in emergency situations subject to certain regulatory conditions. The final results of the trial are still awaited.
BBV152 (COVAXIN) has been developed indigenously by an Indian pharmaceutical company: Bharat Biotech. There is sufficient safety and immunogenicity data from pre-clinical studies. The phase I data recently published in the Lancet portrays that COVAXIN was seen to enhance immune responses and had acceptable safety outcomes. Phase II trial has also been completed, and phase III trial is ongoing in about 25,800 Indian volunteers. In India, the regulatory authority granted an emergency authorization to COVAXIN based on pre-clinical data, Phase I, Phase II data, and interim results generated from the phase III clinical trial.
The approval of COVID-19 vaccines in India is a very important milestone that will lay the foundation for India to supply the vaccines to many other countries in the world. World Health Organization has welcomed and encouraged the regulatory decision on the emergency use authorization of COVID-19 vaccines in India. Although a vast number of people in India have applauded the emergency authorization of COVID-19 vaccines, there are a good number of people who have been shadowed by a sense of doubt fueled by the lack of transparency about the clinical trial protocols and also in part by the non-availability of the detailed trial results in the public domain. In addition to this, Phase III trials in India with both the vaccines have not been completed yet. Even though the complete phase III trial results are not yet available, it is important to educate the public that sufficient data has been generated from the earlier phases of clinical trials and interim results of the phase III trial. This highlights the importance of educating recipients about the regulatory protocols and the essentiality of vaccination in health emergency situations, as posed by the pandemic. Keeping this in mind, the Ministry of Health and Family Welfare in India has created a web portal and helpline number to solve queries related to COVID-19 vaccination.
The COVID-19 vaccination drive in India began on January 16th, 2021, with the initial beneficiaries consisting of Healthcare workers. The drive has now been extended to frontline workers. To date, about 7 million people have already been inoculated with the first dose of the vaccine against COVID-19. India has emerged to be the fastest country to vaccinate a vast number of people within a short time. However, it seems like the journey has just begun. The challenge still seems far from completion considering the huge population of India, i.e., 1.38 billion.
- Recommendations of the SEC meeting to examine COVID-19 related proposals under accelerated approval process made in its 134th meeting held on 01.01.2021. From:https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/134th%20COVID-19%20Recommendation%2001.01.2021.pdf
- Mohapatra PR, Mishra B. Regulatory approval of COVID-19 vaccine for restricted use in clinical trial mode. Lancet Infect Dis. 2021 Jan 25:S1473-3099(21)00045-1.
- Voysey M, Clemens SAC, Madhi SA, et al; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 January 9th;397(10269):99-111.
- Ella R, Vadrevu KM, Jogdand H, et al, Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial. Lancet Infect Dis. 2021 Jan 21:S1473-3099(20)30942-7.
Nishtha Khatri, MD
Assistant Professor, Seth GS Medical College and KEM Hospital, India
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