On Wednesday, the Drugs Controller General of India has granted permission for the conduction of phase-3 clinical trial of COVID-19 vaccine Covovax as a booster dose in adults.
On March 5, the Subject Expert Committee on COVID 19 of the Central Drugs Standard Control Organisation recommended the permission for conducting the phase-3 clinical trial for Covovax as a booster dose in adults who are fully vaccinated with either Covaxin or Covidshield atleast three months ago.
On December 28, last year, the DCGI approved Covovax for restricted use in emergency situations in adults and also for immunizing the beneficiaries in the 12-17-year age group which are subject to certain conditions.
The vaccine, Covovax has not been included in the country’s vaccination programme against COVID-19.
Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India, submitted an application to the DCGI in February to seek permission in order to conduct a phase-3, observer-blind, controlled study for the evaluation of safety and immunogenicity of Covovax.
Prakash Kumar Singh also stated that many countries were being responsible for the booster doses to their citizens in consideration of the uncertainties of the pandemic.
He said that they are sure that their approval for conducting this clinical trial will ensure an early availability of Covovax for booster-doses which will be used for the people of their country as well as the world at large.
He has lined this up with the prime minister’s vision of ‘’Making in India for the World’’.
He also mentioned that their firm is committed to provide world-class life-saving vaccines at an affordable price under the visionary leadership of their CEO, Dr Adar C Poonawala.
He also stated in the application that they request everyone to grant permission so that they can conduct a phase-3 clinical trial for booster dose of Covovax in Indian adults.
Covovax is approved by the European Medicines agency for conditional marketing authorisation and is manufactured by the technology transfer from Novovax.
The vaccine was granted emergency-used listing by the World Health Organisation (WHO) in December 2020.
Also in August 2020, the US-based vaccine maker Novovax Inc., made an announcement on the licence agreement with the SII for the development and commercialisation of NVX-CoV2373.
The agreement was for the COVID-19 vaccine candidate in low and middle income countries and in India.
