Top infectious disease specialist and senior adviser to U.S. President Donald Trump on COVID-19, Dr. Anthony Fauci predicted that India would play an important role in supplying the world with a COVID-19 vaccine.
He was present at a web conference organised by the Indian Council for Medical Research, where he underlined the fact that though the threat posed by COVID-19 was grave, it was not essential now to conduct human challenge trials to expedite vaccine development.
Dr. Fauci, who is the head of the U.S. National Institute of Allergy and Infectious Disease, said that two potential vaccines by Moderna and Pfizer were in advanced stages of human trials.
“India’s manufacturing capabilities is going to be very important. We have made it clear that all tests on vaccines will have to meet regulatory standards and include all ethical review and strong data monitoring and safety boards,” he said at the conference attended by top officials from the ICMR, the Departments of Biotechnology and the Health Ministry.
Human challenge trials involve intentionally infecting healthy vaccinated volunteers with small amounts of the virus. Doing this, researchers can come to know relatively quickly if a test-vaccine works.
While such trials have earlier been conducted for malaria and dengue, researchers are still divided on their ethics. Since COVID-19 is caused by a novel virus and does not have a standard treatment protocol, it is unethical to expose healthy volunteers to that level of risk.
“We recently convened an expert consultation on the issue and the conclusion was that such studies are not necessary at this time. The continuing high incidence of the disease is concerning but it makes randomised control trials quite feasible. We don’t have effective therapies to cure individuals infected. These factors have led us to conclude that human challenges are not essential nor ethically justified presently”, he said.
The conference also saw discussions on a way to ensure that a vaccine, if and when available, is equitably distributed.
“Healthcare workers would be a priority. But there are several other stakeholders, the elderly, those with comorbidities and those extremely marginalised and because of socio-economic conditions are likely to be at particular risk of being severely ill by the infection.”, soon to be Health Secretery Rajesh Bhushan said.