Vaccines: The road to an emergency nod

The past few days have seen a lot of activity from companies who are part of the vaccine race in India. First, Pfizer applied for emergency use authorisation (EUA) of its vaccine candidate. Then it was the turn of Pune-based Serum Institute of India, whose CEO Adar Poonawalla tweeted on Monday that his company, too, had applied for EUA for Covishield, the Oxford-AstraZeneca vaccine candidate. Hyderabad-based Bharat Biotech International, which is developing Covaxin, the country’s first indigenous Covid-19 vaccine in partnership with the Indian Council of Medical Research (ICMR), has also applied for an EUA.

All eyes are now on the Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services, which has to take a call on the matter.

But what exactly is an EUA? Emergency use authorisation is a term which comes under the U.S. Food and Drug Administration's (USFDA's) medical countermeasures or MCMs. These are USFDA-regulated products (biologics, drugs, devices) that may be used in the event of a potential public health emergency.

This was the American emergency preparedness to counter terrorism and emerging threats under the Project Bioshield Act of 2004. Since then, the law has been further strengthened. The USFDA, in 2013, set up the Global Coalition for Regulatory Science Research to meet with the changing nature of regulation. The panel uses advanced data analytics and scientific risk prediction with the use of artificial intelligence. Till date, the USFDA has approved more than 121 MCMs since 2012, and has issued more than 200 EUAs since 2005.

The Indian regulator, though, has a tough task ahead. Amit Dinda, professor at the department of pathology, All India Institute for Medical Sciences, and an executive council member at the Global Coalition for Regulatory Science Research, says that except for Covaxin by Bharat Biotech, which uses an attenuated virus vaccine, it would take time for new technology platforms to get an approval for EUA. The Indian regulator, according to Dinda, would wait till the company applies for approval in a regulated market and receives it.

Once the vaccine is approved in a regulated country and data is submitted to the USFDA or the Medicines and Healthcare products Regulatory Agency (MHRA) of the U.K., the Indian regulator will use the certificate received by the company from that country, examine the data, and endorse it.

In a chat with Fortune India, Dinda explains the process flow for a vaccine to get approval, and whether the Indian regulator is prepared for such approvals. Edited excerpts:

Does India have the provision for medical counter measures as specified in the USFDA regulations?

In the revised CDSCO Act, 2019, EUA, in the name of it or a by-law or Act is not explained. But it is mentioned that if there is an unusual situation where the population is endangered, emergency use may be allowed.

So, EUA, as explained, is not the same as approval, and it may be withdrawn once the emergency is over, right?

EUA is a different path altogether. The moment EUA-based vaccination starts, data of all who receive vaccination will be collated. All unusual side effects and adverse events will be recorded. [There will also be] very strict post-marketing surveillance; once the pandemic is over, there will be enough information for approval too.

Will companies marketing the vaccine have to face liability under EUA?

There is a liability clause but it has more to do with treatment or follow-up. There will be some sort of limited liability. Not a payout.

The company is producing data and submitting the data to a regulator produced through GMP [good manufacturing practices]-certified labs and quality controlled labs. There is a minor possibility of omission and commission and human error. The liability clause is important in EUA, where it talks strictly monitoring data forging and data fudging. Basically, if you put a huge liability, it cautions the companies.

How can regulators fast-track approvals?

Calculation and data computation on drug development has changed dramatically over the last 10 years. The computational data analytics and A.I.-based risk projection or simulation-based models being used are entirely different from earlier. They are more precise. So scientifically and technically, risk assessment is much easier now.

Even in clinical trials, and not just vaccine trials, in the last few years, risk projection is used routinely, and that is why drug trial time in normal drug development has reduced from 8-10 years to 2-3 years. So clinical trials are shorter.

Does India have the competence to evaluate data?

I, as a member of Global Coalition for Regulatory Science Research, have been trying for the last three years to set up an advisory body with all regulators and CDSCO. Drug evaluation is a complex interdisciplinary science. India is still working on it. The problem is that we know the traditional pharmacology and pharmaceutical regulation based on it. But it has limited use in the current scenario where we use mathematical- and A.I.-based modelling and it is changing rapidly.

The USFDA has been gearing up from 2004 and they are fairly advanced. Our regulatory body also needs to put in place a transparent regulatory evaluation process like the EU and USFDA. As the current government is pushing globalisation, regulation, too, has to keep pace.

Indian companies who sell in international markets know the procedure and are geared to meet with international requirements. For example, we have 60 nanotechnology-based products which have been submitted by Indian companies to the USFDA, but our own country does not have an approval pathway and capacity to evaluate them. Some 15-20 may have been submitted to the CDSCO, but the CDSCO is waiting for USFDA approval before they approve the product for use in India.

Are we working on developing the regulatory pathways and capacity to evaluate the drugs being made now?

In India, we will get a regulatory science research platform early next year. It was initiated before Covid-19, but was put on the back-burner; it will be a first of its kind. Allstate regulators will be on the panel and we will build capacity for a regulatory science-based evaluation process.