With two coronavirus disease vaccines (Covid-19) already obtaining emergency use authorization (EUA) in India, it is probable that hiring trial participants will become costly for companies next in line. The Serum Institute of India’s Covishield vaccine and Bharat Biotech‘s Covaxin were authorized at the start of the year by India’s apex drug regulator.
Only the news that vaccination will soon be accessible has had a negative effect on recruiting, the businesses have said. Also without a permit for immediate use, there have been several press releases reporting that the vaccine will eventually be available. And, that has hurt us badly in terms of recruitment because a lot of people asked us whether they should still be participating in the clinical trial if a vaccine was going to be out soon,” said Dr. V Krishna Mohan, executive director at Bharat Biotech, in a webinar held just before the approvals.
He said, unlike in the United Kingdom and the United States, India’s clinical trials are taking place at the same time that vaccinations are converting to EUA.
He said that for Bharat Biotech, the difficulty was greater as they concentrated on individuals in older age groups. He said that the oldest person who registered for the Covaxin trial was 97.
“Hospitals have also asked us whether it is ethical to continue a clinical trial when you have a EUA. These questions need to be answered,” said Dr. Mohan.
The problem for Dr. Pankaj Patel, Chairman of Cadila Healthcare, will be the time needed for recruitment. He said, “The number of vaccines that are being developed or have been developed in the past in India – there are already vaccines available still companies were able to conduct clinical studies and get volunteers and approval. The challenge would be in terms of the speed of recruitment and not in getting the volunteers to come in.”
However, the biggest issue is subgroup research, since those who are the most susceptible are likely to start receiving the vaccine earlier. If we think of vaccines for Covid-19, the first priority is to protect the vulnerable and we are working to make the vaccine safe. We have seen the performance, based on overall effectiveness, from Pfizer, Moderna, and Oxford/AstraZeneca. But is overall effectiveness in the most disadvantaged what we really measure? “said Dr. Gagandeep Kang, senior vaccine expert, and professor at the Christian Medical College-Vellore Wellcome Trust Research Laboratory.