The phase 2/3 trials of the COVOVAX Coronavirus vaccine in children between the ages of 7 and 11 started on September 29, 2021, in Bharati Vidyapeeth Medical College, Pune.
The Medical Director of Pune’s hospital, Dr. Sanjay Lalwani informed that the 2/3 trials of COVOVAX Vaccine for children aged between 7 and 11 have started and that nine children have been enrolled for the trial.
He further added, “for the children who wish to enroll their parents are counseled in local vernacular language and that the audiovisual consulting process has been documented. Once the parents give their consent, the volunteer is subjected to an RT-PCR test and an antibody test. Although, this does not stop the children from being part of the trial.
As many as 9 centers have been identified all over India for the phase 2/3 trials of COVAVAX vaccine for children, including Bharati Vidyapeeth Medical College Hospital in Pune.
COVAVAX: COVID Vaccine trials in childrenDr. Sanjay Lalwani while informing about the COVID-19 vaccine trials in children said that 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 age group of 11-17 where 100s have been enrolled in India. There is a total of 9 sites in India and approximately 1000 children will enroll across the country. Lalwani added that Bharati Vidyapeeth Medical College has started the trial for the age group of 7-11. During the trial of the COVAVAX vaccine in children, two doses at a gap of 21 days will be administered. |
COVAVAX COVID-19 vaccine
The NOVAVAX COVID-19 Vaccine is a subunit Coronavirus vaccine candidate that has been developed by NOVAVAX and the Coalition for Epidemic Preparedness Innovations. The vaccine is undergoing trials in India under the brand name COVAVAX.
The covid-19 vaccine is given to the candidate in two doses administered 21 days apart and is stable at refrigerated temperatures of 2 to 8 degrees Celsius.
COVAVAX is an Indian version of the NOVAVAX Vaccine which has been brought to India for children by the Serum Institute of India.
Permission to conduct COVAVAX trials on children in India
Earlier in July 2021, the Central Drug Authority of India had recommended against granting permission to the Serum Institute of India to conduct phase 2/3 trials of COVAVAX Vaccine on children between the ages 2-17 years. The subject expert committee had said that the permission could not be granted as the vaccine has not been approved in any country.
However, later in the month, permission was granted to SII to conduct a phase 2/3 trial of COVAVAX on children aged between 2 to 17 years with certain conditions on the basis of the recommendation made by the Subject Expert Committee (SEC) on COVID-19.
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