Phase 2/3 trials of the Covovax Covid-19 vaccine in children between ages 7 and 11 began in Pune’s Bharati Vidyapeeth Medical College and Hospital on Wednesday.
“Pune’s Bharati Vidyapeeth Medical College Hospital began phase 2/3 trials of Covovax in children between 7 and 11 years of age on Wednesday. Nine children have been enrolled for the trial here,” said Dr Sanjay Lalwani, the Medical Director of the hospital.
“For the children who wish to enrol their parents are counselled in local vernacular language and the audiovisual consulting process is documented. Once the parents give their consent, then the volunteer is subjected to an RT PCR test and an antibody test. Although, this does not stop them from being a part of the trial,” he added.
As many as nine centres have been identified across India for this phase, including Bharati Vidyapeeth Medical College Hospital. The Covid vaccine trial for the paediatric age group began in India and the age for enrolment for this group is 2-17 years.
“In paediatric, it’s an age de-escalation trial; which means that you start with children of higher age and see the efficacy, and then proceed to the lower ages. So, part one is between the 11-17 age group where 100s have been enrolled in India. There are 9 sites in India and approx 1,000 children will enrol across the county. We at our site have started the trial for the age group of 7-11,” Lalwani said. During the trial, two doses at a gap of 21 days will be administered.
Covovax is the Indian version of the Novovax vaccine brought in India by the Serum Institute of India for children.
Earlier in September, Serum Institute of India CEO Adar Poonawalla said that he is hopeful that Covovax will be ready for recommendation by January or February 2022.
“Covovax has now started trials for children. I think three to four months is the minimum period we need to ascertain how safe and effective and well-accepted it is for children. Don’t forget we are going to go below the age of 12 years in a phased manner so that we can cover almost down to the age of three or four,” Poonawalla had said.
(With ANI inputs)