‘Emergency Use Authorisation’ (EUA) has drawn attention around the world in line with vaccines that can help fight COVID-19.
In India, too, the drug regulator has given Emergency Use Authorisation to three anti-Covid vaccines, the latest one being Russian Sputnik V.
What is Emergency Use Authorisation?
A drug regulator would normally require some evidence for approving a drug, vaccine, device or a test.
In the current pandemic situation, it may not be possible to have all such evidences.
When there is a declared emergency, the regulator can decide whether it is worth releasing a drug or vaccine that is not fully tested for efficacy and safety.
In India’s case, it is the DCGI (Drugs Controller General of India).
If there is evidence to suggest it may benefit patients, then the regulator is well within its rights to issue an EUA to a medical product.
It will then be made widely available for use.
Why is it important?
In a pandemic situation, it is very important to restrain the spread of the pathogen in the quickest possible time.
Typically, developing vaccines or drugs takes several years.
A good part of this goes in carrying out trials to establish the vaccine’s safety and efficacy.
So the longer the wait, more people are likely to die.
So, drug regulators in many countries follow a basic thumb rule.
This is to approve a drug or a vaccine if the known and potential benefits outweigh the known potential risks.
How does it work?
An EUA does not mean that a vaccine has skipped essential safety trials.
The regulators need to satisfy themselves that the product meets reasonable thresholds for safety and effectiveness before granting approval.
In the US, for instance, the Food and Drug Administration grants EUA for Covid vaccines only after -
a vaccine-maker has undertaken Phase 1 and Phase 2 trials
it is able to provide safety and efficacy data for Phase 3 trials as well, using data generated from over 3,000 participants
In Phase 1 trials, a vaccine is given to a limited sample set of healthy people to assess its safety at higher doses.
If Phase 1 does not throw up safety concerns, Phase 2 is undertaken on hundreds of people with different health conditions and from different population strata.
This helps assess both the effectiveness and the side-effects.
Phase 3 involves much larger sample, representative of the actual population, to assess both safety and efficacy.
How is it carried out in India?
The process for using the EUA is less clearly spelt out in India.
But the DGCI has also been issuing EUAs based on clinical trial data.
In January 2021, the DCGI approved the first two vaccines:
Covishield, produced by Pune-based Serum Institute of India under licensing agreement from AstraZeneca
Covaxin, manufactured by Bharat Biotech
The emergency approvals given to the three vaccines in India have helped in rolling out the largest vaccination drive in the world.
But with the second wave proving quicker to spread than the first, capacity constraints are hitting the ramping up of vaccine supplies.
Thus, granting EUA to new vaccines that have already been approved for emergency use in other countries becomes essential.
