We need the world’s drug regulators to come together to scrutinise clinical trial data — not take decisions one after another
Exactly one year later, the world is moving towards the next decisive phase in the fight against the novel coronavirus disease (COVID-19). Vaccines are now available and people are being inoculated — many rich countries have set targets for full immunisation by mid-year. With this done, they say, it can be back to business.
But for this to happen, we need hard introspection of our scientific and political leadership during this critical phase of recovery. Today, on the one hand, the virus is mutating and becoming more unpredictable and there is still too much that we do not know.
For instance, it is not clear if antibodies — that provide protection against the virus — will last beyond a few months in our bodies. If this is the case, then herd immunity — serological surveys in Delhi, for instance, are showing that over 50 per cent of the population could have antibodies — may not be the magic bullet.
On the other hand, the mutating virus is learning faster to find weak spots in our immune system to spread faster as well. The United Kingdom, South Africa and Brazil variants of the virus are found to be more infectious because antibodies cannot detect them. So, it is a war — the virus or us.
Amid all these, the global community — our leadership — is not learning from mistakes of the past year. First, it is important that we understand the principle of inter-dependence. This means that we need to ensure that vaccines are available, affordable and accessible, to all in the world.
Inequity in the distribution of vaccines means that the virus will remain with us; and, it means it will mutate and will find its way into our bodies — perhaps in a variant that we are not protected against.
It is also clear economic costs will be devastating in a situation where large proportions of the global population remain vulnerable. But as yet, it is a dog-eat-dog world and it is every country for its own.
In mid-January this year, when the World Health Organization (WHO) gathered some 2,800 scientists from across the world virtually, they pointed out just how vast and glaring this vaccine divide is. As of now, some 30 million vaccine doses have been administered globally, mostly in advanced economies. WHO’s initiative to provide equitable access to vaccines — COVAX — is devoid of the funds needed to procure and supply the shots to poorer countries.
It is not just lack of money, which is at the core of the problem. It is also the complete lack of scientific cooperation. This is the second lesson that world needs to learn. In this “war”, both speed and scale of the intervention are pre-requisites. There is no doubt that scientific ingenuity, innovation and enterprise have been extraordinary in the past year.
There are already three-four vaccines that have been deployed and many more are in the works. Success will now depend on how fast these can be put to work; and for this, we need to know that the vaccine is both efficacious and more importantly, safe. Currently, all drug regulators in the world are examining the vaccines as they become available.
Pharmaceutical companies are conducting the trials, but it would take months, if not years, for new vaccines, to go through the existing process. But with the world running out of time, there is a need to speed up. How can this be done without compromising on safety?
This is where we need new learning and global cooperation. We need drug regulators of the world to come together to scrutinise the data of the trials — not take decisions one after another.
For instance, the Oxford-AstraZeneca vaccine has been cleared for use in the UK and India, but it is still awaiting the green signal from the European Union, the United States and WHO’s internal process. In the waiting are some 50-odd candidates. Why then can’t national scientific resources be pooled at a global level?
This is also important because there is a need to re-think the drug clearance process. The clinical drug trials are rigorous and rightly so. But the fact is that many more COVID-19 vaccine candidates will be closer to deployment. How quickly will the vaccines get clearance? For instance, phase 3 clinical trials require extensive protocols for giving people the real drug and the placebo.
Will this be possible when people are putting their arms forward desperately for the real thing? All this is only possible if there is global cooperation and if there is credibility in the institutions of decision-making. Governments will have to ensure that there is full disclosure by the pharma companies of clinical trial data.
This must be transparent and available to the public. At present, we have none of this. When the Indian government announced emergency use of a vaccine that had not yet cleared phase 3 clinical trials, it may not have been wrong. But what it completely messed up was its communication.
It seemed that the vaccine was untested; that it had been released to us; and, that this was being done to prove our domestic scientific might. What is clear is that winning this “war” will need more information, strong institutions with credibility and more democracy, not less. What will make us lose forever is vaccine chauvinism.
This was first published in Down To Earth’s print edition (dated 1-15 February, 2021)
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