Written By: Longjam Dineshwori | Updated : September 7, 2020 9:11 AM IST
Bharat Biotech's Covaxin uses an inactivated strain of the novel coronavirus.
Some countries including Russia are expected to start a mass vaccination campaign against coronavirus from January next year. According to media reports, six COVID-19 vaccine candidates have moved to the final stage of clinical trials. These include the ones developed by Russia's Gamaleya research institute, Oxford/AstraZeneca, and Moderna Inc. In Phase 3 trials, the experimental vaccine is given to thousands of people and tested for efficacy and safety. India is also not far behind in the vaccine race. Bharat Biotech is ready to begin phase II clinical trials of the country's indigenous vaccine candidate Covaxin from Monday.
The Hyderabad-based vaccine maker has been given the go-ahead by the Central Drugs Standard Control Organisation under the Directorate General of Health Services to move to the phase II trials.
The phase ll trials will include 380 healthy volunteers, and evaluate the safety, reactogenicity, tolerability and immunogenicity of the whole-virion inactivated SARS-CoV-2 vaccine (BBV152). The participants will be screened for four days after they receive the vaccine shots.
Phase I clinical trials of Covaxin began on July 15 at 12 centres across the country where 375 healthy volunteers were administered two doses of vaccination shots with a gap of 14 days. These trials are still continuing.
Bharat Biotech had developed the vaccine in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). The 'indigenous, inactivated vaccine candidate' was developed and manufactured in Bharat Biotech's high containment facility located in Genome Valley, Hyderabad.
A group of global health experts has proposed a new, three-phase plan for fair distribution of potential Covid-19 vaccine among countries. Called the Fair Priority Model, it focuses on reducing premature deaths and other irreversible health consequences from Covid-19.
Normally, vaccine distribution is based on how severe there is suffering in a given place, but the researcher team argued that the primary measure of suffering ought to be the number of premature deaths that a vaccine would prevent.
In their proposal, the authors suggested three fundamental values that must be considered when distributing a Covid-19 vaccine among countries. These are:
The researchers claimed that their Fair Priority Model addresses these three values by focusing on mitigating three types of harms caused by Covid-19: Death and permanent organ damage, indirect health consequences, such as health care system strain and stress, as well as economic destruction.
According to the authors, preventing death -- especially premature death -- is particularly urgent and it is the focus of Phase 1 of the Fair Priority Model.
In Phase 2, the plan is to capture overall economic improvement so that people would be spared from poverty. Phase 3, on the other hand, focuses on prioritising countries with higher transmission rates and eventually covering all countries. In order to halt transmission, at least 60 to 70 per cent of the population should become immune to the disease, the authors noted.
The authors expressed disapproval of any plan that prioritises countries based on the number of frontline health care workers, the proportion of the population over 65, and the number of people with comorbidities within each country.
They argued that as health care workers already have access to personal protective equipment (PPE) and other advanced infectious disease prevention methods, giving preference to them during vaccination would not substantially reduce harm in higher-income countries.
Focusing on vaccinating countries with older populations first would also not necessarily reduce the spread of the virus or minimise death. One reason is that low and middle-income countries have fewer older residents and health care workers per capita than higher-income countries, the researchers said.
The Fair Priority Model is the best embodiment of the ethical values of limiting harms, benefiting the disadvantaged, and recognising equal concern for all people, the authors concluded.
With inputs from IANS
