Reasons why COVAXIN might Not be Fit for Release on 15th August

COVAXIN is the first indigenous vaccine for novel coronavirus to enter human trials in India. The vaccine was developed as a result of a partnership between Bharat Biotech International Limited, a Hyderabad based company, and the ICMR (Indian Council of Medical Research). It is an inactivated vaccine – made using parts of the killed Covid-19 virus, hence making them unable to infect or replicate. Injecting measured doses of these particles serves to build immunity by helping to create antibodies against the dead virus, according to them. The initial success of the vaccine has put India among the few countries who are racing to provide the world of a cure to rid them of the ongoing pandemic. Globally, AstraZeneca and Moderna are two companies whose vaccine development has reached phase three human trials and is way ahead of us. 

The Trials’ hubbub

Covaxin was granted permission by the Drugs Controller General of India (DCGI) on June 29 to initiate phase 1 and 2 human trials. Following this, the ICMR was quick to announce that they were planning to release the vaccine for public use on August 15^th. In a highly criticised move that goes against scientific norms, the ICMR has identified 12 testing centres and its director, Dr Balram Bhargava sent out a letter asking officials at those centres to expedite the vaccine trials. He also mentioned how all clinical testing must be conducted in time and directed them to finish up enrolment of trial candidates by 7th July. The predetermination and setting of such short timelines for a vaccine before trials have begun is raising eyebrows all over, including the Indian Academy of Sciences.

The Process 

The development and clinical testing of a vaccine is a very delicate process which must be completed with utmost precision and the results be studies for a long enough time period to observe the effects and side effects, if any. Majorly, the clinical testing process is divided into three phases –

• Phase 1: This is the smallest phase of the trial where the safety profile of the vaccine is determined.
• Phase 2: In this phase, the efficacy and side effects of the vaccine is evaluated on a bigger sample size. The immune responses triggered by it are also studied.
• Phase 3: The final stage, phase 3 has a sample size of thousands. This is the phase where the confirmation of safety and efficacy of the vaccine is monitored on a large sample.

It is only after a vaccine passes all three phases successfully is it accepted and released for public use. This entire process often takes several months, and sometimes even years because the data from one phase has to be analysed before the next stage can begin.

The Problems

There are a number of issues that arise with Covaxin being aimed to be tested and released, all in four weeks.

1. The Process appears rushed

Experts and organisations across the world follow the detailed testing procedure of the three phases as mentioned earlier, and such a process usually takes significantly more time than a month. Expediting the process in response to the pandemic might seem like a welcome move, but the repercussions could be everlasting. The testing process is dependant on several factors which alter the time period required and hence, providing a deadline appears to be very ignorant. The IASc in their statement mentioned that, “While administrative approvals can be expedited, the scientific processes of experimentation and data collection have a natural time span that cannot be hastened without compromising standards of scientific rigour. Moreover, if the data of any phase are unacceptable then the clinical trial is required to be immediately aborted.” Understanding the process and applying some common sense, ICMR’s haste does appear to be very rushed and ignorant.

2. Precedent of Failures

Truth be told, the developing of a new vaccine is in itself a very hard business especially owing to the fact that you not only have to fight against the disease but ensure that there are no serious side effects. Talking generally about all vaccines ever developed, statistics show that almost 90% of them fail. Moreover, this is not because lack of anything but sheerly because of how many factors one has to take care before a vaccine can be released to the public for consumption.

3. Logistical Delay

Clinical trials for a vaccine require participation of healthy human volunteers and therefore, many ethical and regulatory approvals need to be obtained before trials can commence. Moreover, owing to the current status in and around India with Corona cases reaching new daily highs, the presence of enough healthy people willing to volunteer for testing might also become an issue, especially for phase three which requires huge participation.

4. Safe enough?

One of the major concerns regarding the fast tracking of the trials is the huge number of ultimate recipients of the vaccine, specifically 1.38 billion Indians, and more. The sole diversity of the population that is to receive the vaccine, from infants and children to senior citizens, is in itself a challenge. Owing to this, the vaccine will have to be tested across all conditions, all age groups, across all factors out of our control that might affect the outcome and only then can it be declared safe and be administered. Fastening of the process should not come at any compromise in detailed testing, and the depiction of the same by the agencies gives rise to the same question in all concerned – Will it be Safe enough?!

5. The Motive in Question

Giving rise to many questions and widespread criticism, the ICMR’s statement has invited doubts on the very motive of such a move. Critics now interpret the announcement of 15^th August as the deadline to be a very politically motivated decision, intended at providing the PM the opportunity to gain mass points during his Independence Day speech.

6. Counter – Effects

If the vaccine is released, and it has any effect even on every one of thousand people owing to the haste, the country would be in a worse situation with the vaccine than without. One cannot and should not push medical science any faster than safety permits for a vaccine has been known to have a reaction worse than disease itself. Dengvaxia, a Dengue fever vaccine had to be withdrawn for this very reason. This would severely affect the trust we, the Indians, place in Indian medicine, the experts and the research, and even shake up their confidence with them ending up feeling responsible for the worsening conditions. Not just that, if unsuccessful, this move could leave an indelible black mark on the reputation of the whole country.

The Way Ahead

A move to fasten up the testing and human trials would have been acceptable and subject to less criticism if there would have been any precedent of the same. However, it can also be argued that if successful, Covaxin would become the precedent for all future vaccines and trials and positively influence our image by leaps and bounds. Being an optimist, I would want the vaccine to be released as soon as possible, and coming from India would be a cherry on top. However, we must realise that the world has suffered enough, Indians, have suffered enough. If there is one thing the average citizen should fear more than contacting the virus right now, it is an incorrectly tested vaccine. For all the reasons above, but also just because of the responsibility that a vaccine brings with itself, COVAXIN appears unfit for release on 15^th August.

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