Covid vaccine emergency use approval: What are the rules in India? Why are 3 vaccines facing hurdle

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 necessary data pertaining to safety and efficacy from Phase 3 human trials which are being conducted in India.

What is the current status?

Pune-based Serum Institute of India is conducting late-stage clinical trials of Oxford-AstraZeneca’s AZD1222 vaccine under the name of Covishield. In its application, the Serum Institute of India has quoted Phase 1 and Phase 2 safety data and efficacy rate from Phase 3 human trials conducted in the UK and Brazil. Meanwhile, Hyderabad-based Bharat Biotech has recently started the Phase 3 human trial of Covaxin. In its application, Bharat Biotech has cited safety data recorded during phase 1 and phase 2 clinical trials. Pfizer-BioNTech’s vaccine was the first in the world to receive EUA as it has approval from the UK and Canada. However, it is yet 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 rules do not have terms like the emergency use authorization or EUA like that of the US, the UK, and other countries. However, the regulatory system in India does have provisions for a “special situation”. The rules have provisions for an “accelerated approval process” depending on the situation. The provisions match the current pandemic situation. In such a situation, the law says that the ‘product’ (medicine, vaccine) needs to have a “meaningful therapeutic benefit”. The law states if required for the treatment of life-threatening diseases like the ongoing Covid pandemic, a new drug, the vaccine can be given approval of the new drug or vaccine shows “remarkable efficacy” during the Phase 2 human trials. However, this approval will be given for temporary use with validity for up to one year, as per the IE report.