The three candidates
COVISHIELD: The Serum Institute of India in Pune is one of the applicants seeing approval for its vaccine candidate, which is a version of the candidate developed by Oxford University and AstraZeneca. The candidate is under trial in India for a few months and is currently in Phase 3, the report added. The application contains the safety data from the first and second phase of trials. Meanwhile, the data for the effectiveness of the vaccine has been taken from the Phase 3 trials of the vaccine conducted in Brazil and the UK.
COVAXIN: The vaccine is being developed by Hyderabad-based Bharat Biotech along with ICMR’s Pune-based National Institute of Virology (NIV). It is under the third phase of trials, which began recently and has not enrolled all the participants required as per the trial’s design. The application, according to the report, mainly relies on the safety data from the Phase 1 and 2 trials.
BNT162b2: US-based pharma giant Pfizer along with German pharma company BioNTech has also applied for approval in India, even though the vaccine has not undergone any trial in the country yet. The application cites results from the trials in the US. The vaccine became the first one to get the approval from the regulator anywhere in the world, after the UK granted authorisation for emergency use last week.
Regulator approval provisions in India
The New Drugs and Clinical Trials Rules, 2019, govern the trials as well as approvals of new drugs and vaccines, the report stated. The Rules, however, do not state “emergency use authorisation”, which is mainly used by regulatory agencies in the US and other countries. The term has gained popularity in the coronavirus pandemic’s context. While the exact term is not used in the Rules, India does have provisions for special situations, like the one right now.
There are provisions for the “accelerated approval process” in many situations, including the likes of the current pandemic. The Rules allow for granting of approval to a drug still under clinical trial, if the product prima facie seems to be of a meaningful therapeutic benefit.
Another relevant provision of the 2019 Rules states that a new drug can be granted accelerated approval if it addresses unmet medical needs and aims to treat a serious or life-threatening condition or a disease which is relevant to the country.
Additionally, the Rules state that approval for a new drug and vaccine can be considered if even the Phase 2 trials report remarkable effectiveness. In such situations, however, there may be a requirement of additional post-approval studies for data generation on larger population.
Thus, the approval granted to under-trial vaccines and drugs is only valid for a year. Due to these provisions, even Bharat Biotech is eligible to apply for approval, even as its third phase is still in early stages.
Difference between Indian regulations and those elsewhere
The provisions in the 2019 Rules are different from the guidelines prescribed by US FDA specifically for the approval of vaccines for COVID-19. The US regulatory body has specified that emergency use authorisation would only be granted after sufficient data from Phase-3 trials, and vaccine developers are not allowed to apply for approval only on the basis of the first and second phases of trials. Moreover, the vaccine candidate must demonstrate a 50% efficacy rate and the data must be generated from trials including well over 3,000 participants.
Approval for vaccines on trials from other countries
The 2019 approval Rules do not specify whether trial data from other countries can be a point of consideration for assessment of accelerated approval in India. However, the health authorities in the country said that the approval would depend on what the experts and scientists make of the data they would be presented with.