India is set to play a key role in ensuring the world gets a vaccine against SARS-CoV-2. “Private sector in India has a very important role to play… as effective COVID-19 vaccines emerge from our research efforts, this manufacturing capacity [for vaccines] will be very, very important,” Dr Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, and White House adviser for COVID-19, said at an e-symposium with top international experts on vaccines, organised by the ICMR.
“Without India, we will not be able to provide enough COVID-19 vaccine to the world's population,” Professor Peter Piot, director of the London School of Hygiene and Tropical Medicine, said at the event. Over half of the world's vaccines were manufactured in India by companies such as the Serum Institute of India, Bharat Biotech, Biological E, Piot said. “Equitable distribution of the vaccine would be important and the emergence of vaccine nationalism, where the country that manufactures provides it only for its citizens was a worrisome issue,” he said.
India was not only at the forefront of development of vaccines, but more readily and importantly, had the capacity to manufacture huge supplies to the world because of its robust industry, said Dr V.K. Paul, Niti Aayog member, said at the seminar. While two of India's candidates were at Phase 1 and Phase 2 stage of human trials, four-five additional candidates had displayed potential and were at different stages of development, Paul said.
At the event, Fauci said that under the Indo-US Vaccine Action programme, the National Institute of Allergy and Infectious Diseases and National Institutes of Health in the US, and the Department of Biotechnology in India had been working on vaccine development for over 30 years now. Three weeks ago, under the aegis of this partnership, 11 vaccine candidates in India had been reviewed, and experts from the two countries had discussed how these could be further developed.
About the vaccine efforts in the US, Fauci said that the under the Operation Warp Speed, half a dozen leading vaccine candidates were under focus, including the Moderna vaccine candidate, that had entered phase 3 trial for evaluating the efficacy of the m-RNA vaccine platform candidate that was developed initially at the NIAID. Over 80 sites had been enrolling subjects in the study in the US, Fauci said. Another m-RNA candidate, being made by pharma giant Pfizer, had initiated Phase2/3 trials, he said. Fauci emphasised on rigorous trials and data safety monitoring boards in vaccine development. Preparing manufacturing capacity for a potential vaccine entailed huge “financial” risk that the US was willing to take, but the safety of study subjects would not be compromised, he added.
In that context, Fauci added that human challenge studies for vaccines were not justified, and not ethical since the full health impact of the disease was still not fully understood, and a highly effective treatment was not yet available.
On the Oxford vaccine candidate, touted to be the world's leading vaccine candidate, Professor Adrian Hill, director, Jenner Institute, University of Oxford, said that, in India, phase 3 trials for the candidate were soon to be started by the Serum Institute of India, that would eventually be making a billion doses. In the UK, Hill said that 10,000 people had been enrolled for the phase 3 trial at 19 sites. The number would soon touch 4,000 in Brazil, even as participants would be recruited in South Africa and the US, too. The results could come in a few weeks to about six months and there was a lot of “uncertainty” still, given the low incidence of the disease and hence the probability of the participants getting infected on their own.