All you wanted to know about emergency use authorisation

‘Emergency Use Authorisation’ has created a buzz around itself world over in the last few months as people wait eagerly for vaccines that can help fight Covid. In India, too, the drug regulator has given Emergency Use Authorisation or EUA to three anti-Covid vaccines, the latest one being Russian Sputnik V.

In the current pandemic situation, it may not be possible to have all the evidence that a drug regulator would normally require for approving a drug, vaccine, device or a test. When there is a declared emergency, the regulator, in India’s case the DCGI, can take a call whether it is worth releasing a drug or vaccine that is not fully tested for efficacy and safety. If there is evidence to suggest it may benefit patients, then the regulator is well within its rights to issue an emergency use authorisation to a medical product to make it widely available for use.

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 you wait more people are likely to die. So, drug regulators in many countries follow a basic thumb rule — to approve a drug or a vaccine if the known and potential benefits outweigh the known potential risks. However, 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 and 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 doesn’t 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.

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, the DCGI approved the first two vaccines — Covishield, produced by Pune-based Serum Institute of India under licensing agreement from AstraZeneca, and Covaxin, manufactured by Bharat Biotech. But with the second wave proving quicker to spread than the first, capacity constraints are hitting the ramping up of vaccine supplies. Thus, the move to grant EUA to new vaccines that have already been approved for emergency use in other countries.

EUAs given by drug regulators have resulted in administration of over 878 million Covid-19 vaccine shots across the world, significantly bringing down infection rates in countries like Israel. The emergency approvals given to the three vaccines in India have helped in rolling out the largest vaccination drive in the world. More than 12 crore vaccine shots have been delivered across the country. A person who has received both the shots of the vaccine is expected to be protected against the virus. Even if he or she contracts the infection, the severity is expected to be much less than a non-vaccinated person.

Sometimes, short-cuts help save lives.

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