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Phase 2/3 Trials of Covovax Vaccine For Children Between Age 7 & 11 Begin in Pune

Pune: The Phase 2/3 trials of Covovax COVID-19 vaccine for children between the age of 7 and 11 began at Bharati Vidyapeeth Medical College and Hospital in Maharashtra’s Pune 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.

Covovax is the Indian version of COVID-19 vaccine developed by US-based Novavax Inc and it is being manufactured in India by Pune-based Serum Institute of India (SII).

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.

(With inputs from ANI)



source https://www.india.com/news/india/phase-2-3-trials-of-covovax-vaccine-for-children-between-age-7-11-begin-in-pune-5001147/

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