Experts emphasis on sticking to rigorous regulatory standards as COVID-19 vaccines enters human trial phase

As COVID vaccine candidates across the world entered different stages of human trials, top global experts on Thursday strongly emphasised on the need to execute these tests with sufficient rigour to meet the standards of regulatory agencies throughout the world. Participating in the ‘International Symposium on the Novel Ideas in Science and Ethics of Vaccines Against COVID-19 Pandemic’, organised by the Indian Council for Medical Research (ICMR), experts also discussed which groups should be prioritised for administering the vaccine whenever it is developed. Anthony S Fauci, the director of the National Institute of Allergy and Infectious Diseases, USA, said a few days ago, phase 3 human trials of mRNA-1273 vaccine candidate commenced. It is being co-developed by the Massachusetts-based biotechnology company Moderna, Inc. and the National Institute of Allergy and Infectious Diseases (NIAID). According to the National Institutes of Health, the trial, which will be conducted at US clinical research sites, is expected to enrol approximately 30,000 adult volunteers. “We have made it clear that all studies will be executed at the regulatory standard with all the required ethical review with the engagement of the community right from the beginning and with strong data and monitoring boards. “We hope others who are supporting COVID-19 vaccine trials will also assure that their trials are executed with sufficient rigour to meet the standards of regulatory agencies throughout the world,” Fauci said. He added that India and the US have partnered for more than 30 years now for the Indo-US vaccine plan called VAP. Three weeks ago, an expert advisory committee reviewed COVID vaccine research and development in India. “Eleven vaccines were reviewed by a panel of experts who provided recommendations for how these candidates can be further developed and assessed and we look forward to continuing this involvement and supporting these vaccines R&D efforts,” he said. In the symposium, Adrian Hill, director Jenner Institute and professor of the Human Genetics at the Oxford University, whose vaccine candidate has already entered phase 3 human trials talked about the stringent norms practised during the phase 3 trials. “So, we were able to get approval to go ahead quickly because of that safety database on the vaccine platform and by now we have vaccinated around 10,000 people in the UK for phase 3 trial,” he said. “It will soon be 4,000 people in Brazil, in the next couple of weeks in South Africa and it will start in the United States in a few weeks as well…around 30,000 people.” He said it can be over 50,000 people by the time they finish. “We don’t know when we get the result…it might be next month or it might take six months,” he said. The Serum Institute of India, the largest vaccine manufacturer in the world, has been chosen by Oxford and its partner AstraZeneca to manufacture the vaccine once it is ready. The SII has also applied for conducting phase 3 trials in the country. Niti Aayog member V K Paul, who is also a member of COVID-19 national task force, stressed that India is committed in a holistic way and pathways have been opened so that trail work is done expeditiously, effectively and by following the best principles of science and ethics. “India’s journey for a safe, effective and affordable COVID-19 vaccine shall be driven by the best scientific and ethical principles and for that our regulatory and scientific mechanisms are already in place, Paul said. Currently, two vaccine candidates Bharat Biotech and Zydus Cadila started phase 1 and 2 human trials. Earlier this month, aiming to launch an indigenous COVID-19 vaccine by August 15, the ICMR had written to select medical institutions and hospitals to fast-track clinical trial approvals for the vaccine candidate COVAXIN being developed in collaboration with Bharat Biotech. The move had come under intense criticism from the scientific community. Experts had also cautioned against rushing the process for developing a COVID-19 vaccine and stressed that it is not acting in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential. During the symposium, there were also deliberations on who will get the vaccine first within any country and globally. Marc Lipsitch, professor of Epidemiology and Director, Center for Communicable Disease Dynamics, Harvard T H Chan School of Public Health, USA said the allocation should be per capita than per healthcare worker. “It also depends on how much vaccine you have. If you have a very small amount. there have also been discussions in international community on if vaccine supply should be proportional to the healthcare workers a country has. I have argued that allocation should be per capita than per healthcare worker,” Lipstich said. On his part, Paul said India’s journey to scale up and access to vaccines by all will be in full compliance with high principles of equity and human rights. “We cannot accept a situation where the rich have the vaccine and not the poor. This is simply unacceptable. We will ensure that pathways are created. We are also working actively to prioritise the groups that should receive the vaccine before the other group and those decisions are in the active stage of being deliberated upon,” Paul added.