About three vaccine candidates are in advanced pre-clinical developmental stage
The Vaccine Maitri Initiative has been launched in line with the principle of contributing to the healthcare needs of the global community
Being at the forefront of covid-19 vaccine development in the world, India, the second-most populous country in the world, is not only aiming to inoculate maximum number of its people against coronavirus but is also aggressively conducting research on decoding the SARS-CoV-2 virus. Dr Renu Swarup, secretary, department of biotechnology (DBT), ministry of science and technology, and a member of the Centre’s National Expert Group on Vaccine Administration (NEGVAC) for covid-19, spoke in an interview with Mint about the latest developments on vaccine development, export and research on the coronavirus. Edited excerpts:
To which countries is India exporting vaccines? How many vaccines will India donate to the WHO’s Covax facility?
The Vaccine Maitri Initiative has been launched in line with the principle of contributing to the healthcare needs of the global community and as announced by Prime Minister Narendra Modi during the UN Summit and Vaccine Summit. Free supplies of covid-19 vaccine have been sent to neighbouring countries including Bhutan, Maldives, Bangladesh, and Nepal.
Consignments are also being made available to Myanmar, Mauritius, and Seychelles. Vaccine supplies to Afghanistan and Sri Lanka are also being considered. Commercial supplies are also being considered for Brazil, Morocco, South Africa, and Saudi Arabia.
Covax is in discussion with many countries and decisions will depend on vaccine manufacturing capacities and availability. Under Vaccine Maitri, the DBT along with the Biotechnology Industry Research Assistance Council (BIRAC), is working closely with the ministry of external affairs and has launched the Partnerships for Accelerating Clinical Trials (PACT) programme for strengthening clinical trial capacity for covid-19 vaccine development in neighbouring and friendly countries.
The PACT initiative has two major components, facilitation of phase III clinical trials of Indian covid vaccines whereby phase III clinical trials of Covaxin in Bangladesh and Myanmar are under consideration, and training for strengthening clinical trial capacities.
The training is being organized to build capacities of the investigators, health workers, technicians, nurses and support staff from hospitals, community health centres, other health agencies, and field sites to gain knowledge of the processes for conduct of trials in compliance with International Conference on Harmonisation- Good Clinical Practise (ICH-GCP) guidelines.
The first series of this training programme received a very encouraging response from our neighbouring countries. Nearly 700 candidates participated across the 10 sessions in the first series from Afghanistan, Bangladesh, Bhutan, Maldives, Mauritius, Nepal, and Sri Lanka. The second series has been launched with representatives from Ethiopia, Kenya, Nigeria, Bahrain, Bhutan, Oman, Nepal, Vietnam, and Myanmar.
What are the covid-19 vaccines in the pipeline and by when will they be available in India?
Nearly 30 covid vaccine candidates are under different stages of development by both academia and industry. Mission Covid Suraksha, has been launched by the DBT, to accelerate the indigenous covid-19 vaccine development efforts and bring the vaccines to market. Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield have already been accorded emergency use authorization. In addition, five vaccine candidates are in various stages of clinical development. The DNA vaccine candidate by Zydus Cadila ZyCov-D and the Russian Sputnik V vaccine candidate are in Phase III clinical trials. The protein subunit vaccine candidate by Biological E is in the Phase I/II clinical trials stage of development. The mRNA Vaccine candidate by Gennova and the nasal single dose vaccine of Bharat Biotech have also been authorised for phase I trial.
About three vaccine candidates are in advanced pre-clinical developmental stage. These vaccines will be available as soon as they have completed the process of development and regulatory clearance. Once the vaccines are developed and cleared for use, the decision regarding their deployment for immunization will be taken.
The DNA vaccine candidate of Zydus Cadila is an indigenous product and should be available after Phase III trial is completed. Gennova Phase I clinical trial has been approved by the regulators and the trials should start shortly. Sputnik V in India submitted their Phase II data to the Drugs Controller General of India (DCGI) and received permission for Phase III trials. They are at present completing the Phase III recruitment.
What is the latest research on the SARS-CoV virus? How do we deal with the new mutant UK strain of coronavirus?
To understand the virus and its interaction with the host systems, the first ‘Pan-India 1000 Genome sequencing of SARS- CoV-2’ was launched by a consortium of DBT autonomous institutes. The consortium completed the sequencing of 1,000 SARS- CoV-2 genomes from across the country.
Initial results indicated the presence of multiple lineages of SARS-CoV-2 circulating in India, probably introduced by travel from Europe, the US, and East Asia. The study identified the A2a haplotype as the most predominant strain and the Indian strains have been observed to share greater than 99.5% sequence homology with strains reported globally.
In view of the emergence of mutant variant of SARS- CoV-2 virus in UK, the Indian SARS-CoV-2 Genomic Consortium (INSACOG) has been launched to ascertain the presence of the UK mutant or any other new variant of SARS-CoV-2 in the country. DBT, along with Union health ministry, Indian Council of Medical Research and the Council of Scientific and Industrial Research have set up a network of 10 laboratories working closely with the National Centre for Disease Control Delhi to take up sequencing to monitor the genomic variations on a regular basis and establish a sentinel surveillance for early detection of SARS-CoV-2 genomic variants with public health implication.
India is contributing the sequences to the global database. There is now a global agreement and WHO has also asked countries to do more genomic sequencing if we have to understand this virus better. Molecular surveillance is essential and is now being strengthened. This will be beneficial for our rapid response not just for covid but also other public health emergencies.
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