There is a debate on whether the Government of India should have approved Covaxin and Covishield vaccines. Apparently, the vaccines get approved basis the trial results, peer review, and the hard science backing them. There are no queries/discussions, leave aside the lingering skepticism. However, the misgivings in India cropped up due to the “scientific” process followed by the Government for approving Covaxin and Covishield.
Covishield has been approved basis the Phase 3 trials in the United Kingdom and Brazil. Serum Institute of India did Phase 3 trials in India on 1600 participants for the same vaccine; however, the data/results are not public yet. US FDA has serious issues with the credibility of AstraZeneca trials and it doesn’t seem to approve it in the foreseeable future. Euro Zone countries, too, have not approved this vaccine, till now.
Bharat Biotech was in the process of completing the recruitment of volunteers for Phase 3 trials. Simultaneously, it got the approval for Covaxin. Meaning, Bharat Biotech is doing the largest Phase 3 trials in the world, not just for COVID-19 but for any vaccine ever produced. All the people who receive Covaxin are unwitting volunteers for Phase 3 trials.
In this scenario, what “scientific” evidence would have compelled the Government to approve Covaxin and Covishield? To be honest, there cannot be any science behind these approvals. Leave aside the trials data and the efficacy results, these vaccines have not even completed the due process. Then, why have they been given a go-ahead?
Well, the Government had no option but to approve them regardless. Realistically, given the turn of events, what else could have the Government done? So, what are these reasons behind the non-scientific yet fact-of-life approval in India for Covaxin and Covishield?
India cannot afford Pfizer and Moderna vaccines
There is no way that India can afford Rs. 1400/- for a dose of Pfizer and Moderna is twice as expensive. Coupled with the storage requirements of -70 degree Celsius for these vaccines, it is a no-brainer that India has no interest in them. Similarly, these two companies have no interest in India either.
Pfizer applied for Emergency User Authorization (EUA), but never appeared for presenting its data. Moderna did not get into any pretence of applying to Indian authorities, altogether. Why waste time, it might have thought.
The other countries actively pursued Pfizer and Moderna, placed advance orders, and paid the money upfront. The Indian Government didn’t get into any such hassle. Why bother chasing which you can’t pay for?
Vaccination starts world-wide
The developed countries started vaccinating their citizens in December 2020. What to do now?
The Indian Government can’t be seen to be left behind; else it will be considered inept and not caring enough for the Indian citizens. The delay in COVID-19 immunization would be severely bad optics and image management for the supreme leader. Narendra Modi has cultivated his image as a man of action and a messiah for the Indians. So, he has to be seen doing something on COVID-19 vaccines. But, he can’t pay for the vaccines that other countries are buying. Enter Covaxin and Covishield.
SII and Bharat Biotech applied for EUA in India only after the US approved Pfizer. Then, SII had no Phase 3 data even from AstraZeneca trials. Bharat Biotech had just about finished Phase 2 trials. They had no business applying for EUA, but they did. Rather, they were asked to apply.
Covishield was given a green signal in India after AstraZeneca got the approval in the UK. Covaxin was approved the next day, as India would not be held captive to only one company. The Indian company was low on data, so it should follow the company which was relatively more credible. It was a foregone conclusion that the Indian Government will approve both the vaccines, that too in the order of SII and Bharat Biotech. And, so it did.
India has reached herd immunity
Globally, India has the sole distinction of having a single wave of COVID-19. Come coronavirus variants, come winter, come State elections, and with no masks, no social distancing norms adhered to, India shall not have a second wave.
The Indian government knows better than anyone that the country has already crossed the herd immunity. However, it cannot be formally announced, for it shows the utter ineptness of the Government that left the citizens to fend for themselves. So, how to announce that India has officially defeated COVID-19? Enter Covaxin and Covishield.
Both these vaccines have completed their animal trials and Phase 1 trials. It means that they may or may not kill COVID-19, but will not kill humans for sure. They are safe enough, even as a placebo. And, anyway, with the by now prevalent herd immunity, the efficacy is not the required criterion. When the virus could not kill us, what can a mere vaccine do to us?
So, get on with the vaccination. It gives confidence to the people that they are safe and protected, which they already were.
In nutshell, we get what we deserve. Indians deserve Covaxin and Covishield and that is what Indians get.