Pune-primarily based Serum Institute of India is conducting late-stage clinical trials of Oxford-AstraZeneca’s AZD1222 vaccine beneath the name of Covishield. (Reuters image)
Coronavirus Covid-19 vaccine in India: As crores of Indians are waiting for a dose of Covid-19 vaccine, Serum Institute of India, Pfizer-BioNTech, and Bharat Biotech have submitted applications for emergency use authorization (EUA) to Central Drug Standard Control Organisation (CDSCO). The emergency use approval has been sought for Oxford-AstraZeneca’s COVISHIELD, indigenous COVAXIN, and BNT162b2 Coronavirus vaccine candidates. However, none of the aforementioned Vaccine candidates have important information pertaining to security and efficacy from Phase 3 human trials which are becoming performed in India.
What is the present status?
Pune-primarily based Serum Institute of India is conducting late-stage clinical trials of Oxford-AstraZeneca’s AZD1222 vaccine beneath the name of Covishield. In its application, the Serum Institute of India has quoted Phase 1 and Phase 2 security information and efficacy price from Phase 3 human trials performed in the UK and Brazil. Meanwhile, Hyderabad-primarily based Bharat Biotech has lately began the Phase 3 human trial of Covaxin. In its application, Bharat Biotech has cited security information recorded through phase 1 and phase 2 clinical trials. Pfizer-BioNTech’s vaccine was the very first in the globe to obtain EUA as it has approval from the UK and Canada. However, it is however to conduct any level of human trials in India, according to an Indian Express report.
In India, New Drugs and Clinical Trials Rules, 2019 lay the provisions for the approval of clinical trials of new medicines and vaccines. However, the guidelines do not have terms like the emergency use authorization or EUA like that of the US, the UK, and other nations. However, the regulatory technique in India does have provisions for a “special situation”. The guidelines have provisions for an “accelerated approval process” based on the scenario. The provisions match the present pandemic scenario. In such a scenario, the law says that the ‘product’ (medicine, vaccine) demands to have a “meaningful therapeutic benefit”. The law states if necessary for the therapy of life-threatening ailments like the ongoing Covid pandemic, a new drug, the vaccine can be provided approval of the new drug or vaccine shows “remarkable efficacy” through the Phase 2 human trials. However, this approval will be provided for short-term use with validity for up to one particular year, as per the IE report.