Questionable recruitment practices in Zydus Cadila’s COVID-19 vaccine trial

A doctor in Guwahati holds a bottle with a COVID-19 vaccine on 28 November 2020. Prime Minister Narendra Modi visited Zydus Biotech Park in Ahmedabad to review coronavirus vaccine development work at facilities. David Talukdar/ NurPhoto/ Getty Images

In February, messages circulating on Whatsapp announced recruitments for a clinical trial of a COVID-19 vaccine, being conducted at hospitals in Bangalore and Mumbai. The messages did not mention the pharmaceutical company that was conducting the trials, but mentioned a fee that each participant would get and phone numbers of the people to contact. The Caravan has found that the texts were intended to recruit people into Indian pharmaceutical company Zydus Cadila’s ongoing trial. The contacts listed in the messages were those of recruiting agents who are not part of the company or of the clinical-investigation teams.  

Zydus Cadila is conducting a phase-three human trial for its COVID-19 vaccine candidate. The first and second phases of a vaccine clinical trial establish basic safety and immunogenicity—ability to elicit and immune response— in a small, often homogenous group of participants. A phase-three trial tests the vaccine in a large, more diverse group of volunteers for efficacy. In the case of the vaccine, efficacy is by how much can it reduce transmission or severity of an infection. Zydus Cadila, which began recruitment in mid-January, has said that it aims to recruit 30,000 volunteers for the trial across 45 sites across the country. The trial is randomised, double-blinded and placebo-controlled. The trial protocol uploaded on the Clinical Trial Registry of India said that it is being conducted to test the safety, immunogenicity and efficacy of the vaccine. Zydus Cadila wrote in an email to me that it has not commissioned third parties to conduct recruitments. I contacted the numbers listed on the Whatsapp messages and spoke to middlemen who said they had been commissioned by the company. 

A Whatsapp message for recruitment at NRR Hospital promised “Free, Corona vaccine trials” to volunteers from across the country. NRR Hospital is listed as a site for the Zydus Cadila trial in the CTRI.  The message said each volunteer would get Rs 500 per visit over four visits—a total of Rs 2,000. It added that a volunteer needed to be older than 18 and to have a body mass index between 18 and 30. The message had contact details of two persons named BK Reddy and Murali Putla. The latter said that he was getting paid by the Zydus Cadila to recruit participants. “We get a commission from the sponsors, we take no money directly from the participants,” he said. 

The WhatsApp message calling for volunteers for Zydus Cadila's COVID-19 vaccine trial at NRR Hospital in Bangalore.