Bharat Biotech's Covaxin trials approved in children between 2 and 18 years
- In Reports
- 07:18 PM, May 12, 2021
- Myind Staff
Bharat Biotech has been granted approval from India’s drugs regulator to begin conducting of clinical trials on children for coronavirus disease (COVID-19) vaccine, Covaxin, making it the first COVID-19 vaccine to be tested on children in India.
The approval has been granted for testing the vaccine on children between 2 and 18 years of age.
The Hyderabad-based firm was asked to submit a revised clinical trials protocol for children in the SEC meeting of CDSCO on February 24.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Tuesday approved of the trials, with certain conditions, officials aware of the matter confirmed.
An official privy to the matter confirmed, "The panel approval is for the phase II/III trials under certain conditions."
Reports suggest that the trial is planned to be conducted among 525 participants at multiple locations. The hospitals include All India Institute of Medical Sciences (AIIMS), Delhi, and AIIMS in Patna.
The aim of conducting the clinical trials will be to evaluate the Covaxin vaccine in children for safety, reactogenicity and immunogenicity.
At present, the Pfizer-BioNTECH Covid-19 vaccine has been approved by US FDA for use on children between 12 and 15 years in the US.
In another development, the Bombay high court has permitted Biovet Private Limited, an associate company of Bharat Biotech, to take possession of a fully functional and ready-to-use vaccine manufacturing plant on a 12-hectare plot in Pune to produce Covaxin. Bharat Biotech produces Covaxin, a vaccine against COVID-19.
A division bench of Justices K K Tated and N R Borkar on May 6 heard an application filed by Karnataka's Biovet Private Limited directing the Maharashtra government to hand over possession of the manufacturing unit at Manjari Khurd village in Pune,
When Biovet sought the government's approval for the transfer, the deputy conservator of forests (Pune division) objected, saying that it was a reserved forest area.
The HC said considering the COVID-19 pandemic situation, the concerned authorities are directed to handover peaceful possession of the ready-to-use BSL-3 vaccine manufacturing facility.
"The respondent (state government) is directed to grant appropriate licences/permissions/NOCs to the applicant (Biovet) in a time-bound manner to enable manufacture of the Food and Mouth Disease vaccine, Covaxin and other life-saving vaccines," the HC said.
Image courtesy: AFP
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