Why in news?
Three vaccine developers in India have sought emergency use approval from Central Drug Standard Control Organisation (CDSCO) for their candidate Covid-19 vaccines under trials.
What are these vaccine candidates?
- COVISHIELD - Pune-based Serum Institute of India (SII) has sought approval for its version of the vaccine developed by Oxford University and AstraZeneca.
- It has been testing this in India for the last few months.
- The candidate is currently in phase-III trials in India.
- In its application, SII has submitted the safety data from phase I and phase II trials.
- The effectiveness data has been sourced from phase-III trials of the same vaccine in the UK and Brazil.
- COVAXIN - Bharat Biotech, a Hyderabad-based company is developing a vaccine, Covaxin.
- It is developing it in collaboration with National Institute of Virology, an ICMR institute in Pune.
- It has started phase-III trials only recently, and is yet to enrol all the participants as per its design.
- Its application is based mainly on the safety data from phase-I and phase-II trials.
- BNT162b2 - US pharmaceutical major Pfizer has not carried out clinical trials in India of its vaccine developed in collaboration with BioNTech.
- But it has still sought an approval to use it in India based on the results of the trials conducted in the US.
- The Pfizer-BioNTech vaccine is the first one to receive regulator’s approval anywhere in the world.
- It was granted emergency use authorisation in the UK recently.
- Notably, none of the three vaccine candidates has yet generated data about the effectiveness of their vaccine from phase-III trials conducted in India.
What are the regulatory provisions for approval of vaccines in India?
- Clinical trials of new drugs and vaccines, and their approvals, are governed by the New Drugs and Clinical Trials Rules, 2019.
- These Rules do not use the term “emergency use authorisation”.
- This term is used mainly by the regulatory agencies in the US and some other countries.
- It has become popular in the context of the current epidemic.
- However, Indian regulatory system does have provisions for “special situations” like the current one.
- The 2019 rules provide for “accelerated approval process” in several situations.
What is the accelerated approval process?
- The accelerated approval process would include situations like the current pandemic.
- In such situations, there is a provision for granting approval to a drug that is still in clinical trials.
- However, this is applicable “provided there is a prima facie case of the product being of meaningful therapeutic benefit”.
- Accelerated approval may also be granted to a new drug if it is intended for the treatment of -
- a serious, or life-threatening condition, (or)
- disease of special relevance to the country, and addresses unmet medical needs
- The definition of new drug in the 2019 Rules includes a vaccine.
- Further, it makes it clear that a new drug, or a vaccine, can be considered for approval if “remarkable” effectiveness is reported even from phase-II trials.
- In such cases, additional post licensure studies may be required to be conducted after approval to generate the data on larger population.
- Accordingly, the approval granted to drugs or vaccines that are still in clinical trials is temporary and valid only for one year.
How different are Indian regulations?
- Some provisions in the 2019 Rules are different compared to what has been prescribed by the US Food and Drugs Administration (FDA).
- The US FDA had issued very specific guidelines for approval of vaccines for Covid-19.
- According to it, an emergency use authorisation can be considered only after sufficient data from phase-3 trials are generated.
- An application cannot be made on the basis of data only from phase-1 or phase-2 trials.
- It has also said that preliminary phase-3 data should show at least 50% effectiveness in preventing the disease.
- Also, this data has to be generated from “well over” 3,000 trial participants.
What about trials made outside India?
- The 2019 Rules do not specify if data from a trial conducted in another country could be considered for accelerated approval to a drug or vaccine to be used in India.
- But the Indian health authorities seem to be open about it.
- It would all depend on what scientists and experts make of the data that are presented to them.
- They will carefully weigh the risks with the potential benefits of the vaccine.
- In this line, the expert committee in India would be willing to look at data generated during trials conducted in other countries as well.
- This is the case with the applications made by Serum Institute and Pfizer.
- The subject expert committees can reject an application or ask for more data if not satisfied.
Source: The Indian Express
