Mumbai facing shortage of children for Covid-19 vaccine trial

The Brihanmumbai Municipal Corporation's (BMC) Nair hospital is facing a new hurdle in its vaccine trial for children, as most of them fail the eligibility criteria of being negative for Covid-19 antibodies.

The hospital had started the clinical trial of two-dose Covovax vaccine for children aged 2-17 years earlier this month. It has to enrol 920 children for the trial. So far, they have managed to recruit and vaccinate only nine children. The second dose of Covovax, a vaccine developed by US-based Novavax and being produced in the country by the Serum Institute of India, has to be given 21 days later.

Dr Ramesh Bharmal, dean of Nair hospital, said, "For every clinical trial, there is inclusion and exclusion criteria. In the Covovax trial, one of the important inclusion criteria is antibody-negative. By now, according to the 4th sero-survey, 50-60 per cent of the children's population in Mumbai has antibodies. Going through the eligibility criteria, many volunteers are getting excluded."

‘Will advertise trial'

Severe comorbidities and illness are the other exclusion criteria, he said. "We are hoping that in the coming days, we will have more children. We are getting enquiry calls. We plan to spread awareness and have advertisements about the trial," Dr Bharmal added.

Volunteers vaccinated with Covovax will be monitored for six months. Representation pic

Dr Bharmal said the vaccinated volunteers will be monitored for six months and their antibodies will be checked on the 18th, 21st and 36th day from the first dose. "The vaccine has so far been given to around 30,000 children in the world," he said. As Nair hospital had initially received poor response for ZyCOV-D trial, it had decided to take the help of media, and sensitise parents on the Covovax trial.

‘Take help of media'

"In the ZyCOV-D trial, we were supposed to enrol 50 children, but only 12 registered. We have been trying to spread awareness through the media on the latest trial. Hopefully this will be successful," said Dr Bharmal.

Apart from Nair Hospital in Mumbai, Bharati Hospital and KEM hospital's Vadu branch in Pune are among the 10 sites where children are participating in ongoing advanced trials. Novavax's Phase 3 trial of Covovax showed 100 per cent protection against moderate to severe impact of the virus and an overall efficacy of 90.4 per cent.

920
No. of kids needed for the clinical trial