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Top infectious disease expert Anthony Fauci, who is leading Covid-19 response for the US, said that use of human challenge studies for Covid-19 vaccines are not ethically justified in the present time. Fauci was speaking at the International Symposium on novel ideas in science and ethics of vaccines against the pandemic, organised by Indian Council of Medical Research (ICMR).
79-year-old Fauci is the director of National Institute of Allergy and Infectious Diseases in the US since 1984.
“We recently convened an expert consultation on this issue, and concluded that human challenge studies are not necessary at this time. Continuing high incidence of the disease is quite concerning to all of us from a public health standpoint. Impact of SARS-CoV2 infection is not fully understood and we do not have highly effective therapies that are available to cure individuals infected in challenge studies and therefore they are not essential or ethically justified in the present time,” Fauci said.
Human challenge studies involve injecting young healthy volunteers with a live SARS-CoV2 virus in controlled settings for purposes of vaccine development.
Marc Lipstich, Epidemiologist at Harvard TH Chan School of Public Health who has published a paper - Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure, stated, “Human challenge studies are proposed to shorten duration in which vaccines can be brought about. These can be used as an adjunct to other methods but can be undertaken later when the raging pandemic ends but preparations need to start early.”
On access to a possible vaccine and who will get it first, Fauci said, “In US, agencies have invested heavily in advanced vaccine production to get a head start in having large supplies available. This is an expensive approach with significant financial risk, but will shorten lag time between proof of efficacy and production scale up. The risk is financial and we are willing to take it given the urgency of the situation.”
Prioritisation
Rajesh Bhushan, Secretary, Ministry of Health and Family Welfare, said the ministry is tackling several issues on vaccines, so as to who should get it first in terms of prioritisation. “Healthcare workers have the best claim to the vaccine as of now. Later whether elderly, or those with comorbidities should receive it, or whether those who are in conditions of prolonged poverty and malnutrition should receive it are the questions we are grappling with at the moment.”
Yogesh Jain, founder of Jan Swasthya Abhiyan, stated that there should ideally be no patents or profiteering and that a potential vaccine should be a public good. Lipstich, however, said, “While it is ideal that a vaccine should be a public good, it is doubtful whether this will happen, considering vaccine development is a very complicated process.”