India, along with the world, maybe at the cusp of a vaccine but companies which are involved in testing the vaccines have said there have been challenges in recruiting volunteers.
On December 22, Hyderabad-based Bharat Biotech (BB) said it has recruited 13,000 volunteers across the country which was the halfway mark for its target of 26,000.
Krishna Mohan, Executive Director, BB, said in a webinar on Thursday there were ‘challenges’ in recruitment. This was partly because, he said, several people were under the impression that a vaccine would be soon available and so didn’t see a point in participating in a trial, where there was only a 50% chance of getting the actual vaccine. The phase-3 trials under way involve people at various hospitals getting a dummy shot or a real shot three-four weeks apart in so-called double blinded placebo trials. “There were press releases that said a vaccine would be available by Dec 15 or 26 and that has hurt us badly in terms of recruitment. Because there is an overlap between clinical trials and EUA this has posed a challenge in terms of recruitment,” said Mr. Mohan.
V.G. Somani, Drug Controller General of India, also a participant at the webinar, agreed that there would be challenges in recruitment but said he didn’t foresee such a problem immediately. “For the next 3-4 months we don’t see a problem, but going ahead [when the vaccine is more widely available] there could be problems in recruitment.”
Mr. Mohan said his company had additional challenges because their recruitment norms required that a certain percentage of volunteers be over 50. “In spite of these challenges, we have had volunteers who were aged 97, 81, 91 come in and be part of the trial.”
However Pankaj Patel, Chairman, Zydus Cadilla which is also set to begin testing a DNA-vaccine candidate in 30,000 volunteers, said he anticipated difficulties with getting volunteers quickly but not with actually getting them. “There are enough number of people committed to helping clinical studies. It might take longer but there won’t be a challenge with recruitment.”
Other experts pointed to concerns around the public perception of clinical trials.
Gagandeep Kang, Professor, CMC Vellore, who was closely involved in the development of an indigenous rotavirus vaccine, said: “People still view participating in clinical trials as being guinea pigs and we have done nothing to address the trust issues relating to clinical research. We are now seeing significant problems in recruitment in Phase-3 trials because our communication strategies about clinical research tend to be very limited.
“The pandemic has seen a dramatic change in academia, industry and funding agencies working together. It’s a fantastic start and we are seeing results but we have a long way to go.”
Umesh Shaligram, Director, R&D, Serum Institute said his company had a stockpile of 75 million doses of the Oxford vaccine and by the first week of January will have 100 million doses. “India is the only country that has such a stockpile,” he said.
