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Experts attach importance to adhering to strict regulatory standards when COVID-19 vaccines enter the human testing phase




warned against accelerating the process of developing a COVID-19 vaccine and stressed that it would not meet the globally recognized standards to accelerate vaccine development for diseases with pandemic potential.

As COVID vaccine candidates entered various stages of human studies around the world, global top experts stressed on Thursday the need to conduct these tests with sufficient accuracy to meet regulatory standards around the world.

When participating in the “International Symposium on Novel Ideas in Science and Ethics of Vaccines Against COVID-1

9 Pandemic” organized by the International Council for Medical Research (ICMR), experts also discussed which groups should be prioritized for vaccine administration whenever this is the case developed.

Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, USA, said a few days ago that human phase 3 studies had started with an mRNA-1273 vaccine candidate. It is being developed jointly 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, approximately 30,000 adult volunteers are expected to participate in the study, which is being conducted at U.S. clinical research sites.

“We have made it clear that all regulatory-standard studies with all the necessary ethical reviews involving the community are carried out from the start and with strong data and monitoring bodies.

“We hope that others who support COVID-19 vaccine trials will also ensure that their trials are conducted with sufficient accuracy to meet regulatory standards around the world,” said Fauci.

He added that India and the United States have partnered for the Indian-American vaccination plan called VAP for more than 30 years.

Three weeks ago, an advisory board reviewed the research and development of COVID vaccines in India.

“Eleven vaccines were reviewed by a group of experts who made recommendations on how to further develop and evaluate these candidates. We look forward to continuing this involvement and supporting the research and development efforts of these vaccines,” he said.

At the symposium, Adrian Hill, director of the Jenner Institute and professor of human genetics at Oxford University, whose vaccine candidate had already entered phase 3 human trials, spoke about the strict standards that were applied during the phase 3 trials.

“Thanks to this safety database on the vaccine platform, we were able to get a fast-track approval. We have now vaccinated around 10,000 people in the UK for the phase 3 trial,” he said.

“There will soon be 4,000 people in Brazil, in the next few weeks in South Africa, and it will also start in the United States in a few weeks … around 30,000 people.”

He said it could be over 50,000 people by the end.

“We don’t know when we will get the result … it could be next month or it could take six months,” he said.

The Serum Institute of India, the world’s largest vaccine manufacturer, was selected by Oxford and its partner AstraZeneca to manufacture the vaccine once it is ready. The SII has also requested phase 3 trials to be conducted in the country.

Niti Aayog member VK Paul, who is also a member of the national COVID-19 task force, emphasized that India was committed to all things and that paths were opened so that trail work could be carried out quickly, effectively and according to the best principles of science can and ethics.

“India’s path to a safe, effective, and affordable COVID-19 vaccine should be guided by the best scientific and ethical principles, and our regulatory and scientific mechanisms are already in place, Paul said.

Currently, two vaccine candidates, Bharat Biotech and Zydus Cadila, have started human trials in phases 1 and 2.

Earlier this month, the ICMR had written to selected medical facilities and hospitals with a view to launching a domestic COVID-19 vaccine by August 15 to approve clinical trials for the vaccine candidate COVAXIN, in collaboration with Bharat Biotech is being developed to accelerate.

The move had been heavily criticized by the scientific community.

Experts also warned that the process to develop a COVID-19 vaccine should be speeded up, stressing that it does not meet globally recognized standards to accelerate vaccine development for diseases with pandemic potential.

During the symposium, there were also considerations about who will receive the vaccine first in a country and worldwide.

Marc Lipsitch, professor of epidemiology and director of the Center for Communicable Diseases Dynamics at Harvard TH Chan School of Public Health in the United States, said the allocation should be per capita as per health care worker.

“It also depends on how much vaccine you have. If you have a very small amount. There has also been discussion in the international community about whether vaccine supply should be proportional to a country’s healthcare workers. I argued that The allocation should be made per head as per health care worker, “said Lipstich.

For his part, Paul said India’s road to scaling and accessing everyone to vaccines will fully comply with the high principles of justice and human rights.

“We cannot accept a situation where the rich have the vaccine and not the poor. This is simply unacceptable. We will make sure that ways are created. We are also actively working to prepare the groups who will receive the vaccine The other group and those who prioritize decisions are in the active phase of the consultation, “added Paul.


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