Mumbai’s KEM Hospital starts clinical trial for Covovax
Civic-run King Edward Memorial (KEM) hospital, Parel, has started a clinical trial on adults above 18 years for the Novavax Covid-19 vaccine, known in India as Covovax
Civic-run King Edward Memorial (KEM) hospital, Parel, has started a clinical trial on adults above 18 years for the Novavax Covid-19 vaccine, known in India as Covovax. Four other hospitals have also been selected for the trial.
Covovax is the Indian version of the Covid-19 vaccine, originally developed by US-based Novavax Inc, that is being manufactured in India by Pune-based Serum Institute of India (SII). Results of the phase three trial have demonstrated 100% protection against moderate and severe disease, and 90.4% overall efficacy.
Confirming the development, Dr Hemant Deshmukh, dean of KEM Hospital, said, “The clinical trial has started among adults above 18 years at the hospital as part of the national phase two and three clinical trials.” Deshmukh, however, refused to divulge any other information due to the non-disclosure rule of the hospital’s ethics committee that approved the trial.
Around 80 volunteers above the age of 18 years will be part of the trial. As per the Clinical Trial Registry issued on June 29, a nationwide clinical trial will be conducted on 1,600 volunteers across 20 hospitals. Of this, five have been selected from Maharashtra. Other than KEM, the list includes Government Medical College and Hospital, Nagpur and three hospitals from Pune—Dr DY Patil Medical College, Noble Hospital and Sahyadri Super Speciality Hospital.
Two shots will be given to the volunteers. The second dose will be given on the 22nd day of taking the first jab. Also, the written consent has been taken from the participants.
“All participants will be tested for Covid-19 to overrule any possible Covid-19 infection. This also includes testing them for antibodies. Individuals who have been vaccinated or earlier infected with novel coronavirus can’t take part in the trial,” said a senior officer from BMC.
As reported, SII plans to apply for permission from the Drug Controller and General of India (DCGI) to conduct a clinical trial of the same among the paediatric population.
Covovax is the second vaccine being made by Serum, the first being the Oxford-AstraZeneca Covid-19 vaccine, produced in India by SII as ‘Covishield’.