Many times, even after a successful Phase 3 trial, problems can persist, or new ones can crop up as we are seeing the virus is mutating.
Here’s a dose of Indian vaccine nationalism. We are a country where the head of a leading national pharmaceutical company said in a Zoom media conference: “We don’t know what approval in clinical trial mode means, give us some time to understand this.” But prior to this statement, Dr Krishna Ella, Chairman & Managing Director of Bharat Biotech International Limited had said, “Approval in clinical trial mode means we don’t need a placebo. It is an open label, where we keep vaccinating people.”
After his presser, I called some medical professionals who have been at the frontline of the corona battle from the outset and have been waiting for the vaccine. They have been tracking every trial, be it in the United Kingdom, Russia, the United States and here, at the Serum Institute too. They are clear about one thing — they will take the Oxford Covid-19 vaccine. I, for one, have become even more sceptical of the entire vaccine development process in India. I am questioning the safety, efficacy and whether I should risk taking the vaccine. I am not against it, but after the questioning, Ella claimed they received brickbats because they were an Indian company!
EFFICACY OF DRUGS
Now, compare what a national pharmaceutical company head said about the Phase 3 trials and clinical trial approval to what the Oxford-AstraZeneca vaccine developers said. The Oxford Covid-19 team has been working round the clock to develop the vaccine. On November 23, the University of Oxford, in collaboration with AstraZeneca Plc, announced that interim trial data from the Phase 3 trials showed their vaccine has been effective in preventing Covid-19 and offers a high level of protection. Ella said, “No interim data on efficacy has been submitted to drug regulator.” This is our reality, where clinical trial approval is being given zero importance. Medical professionals feel, and rightly so, if this is the attitude of a pharmaceutical head, he should shut down his company.
Why the clinical trial approvals are important, a layman needs to know. Many times, even after a successful Phase 3 trial, problems can persist, or new ones can crop up as we are seeing the virus is mutating. This is the reason, there is a Phase IV. Often, drugs or vaccines are withdrawn for a short period or permanently, if the risks of side effects are graver. There is a list of such drugs and vaccines that have been withdrawn. Also, we have seen often how these banned drugs in the US, the UK and Europe are sold in India and that too, over-the-counter. Given our laws and how long-drawn-out our court proceedings can be, pharmaceutical companies get enough time to manufacture and sell banned drugs.
Interestingly, the reasons why banned drugs in developed countries find a place on our shelves are–commercial interests of pharmaceutical companies, corruption (so obvious right?), lack of transparency and accountability, delays in enforcing bans, regulatory bodies lacking enforcement power, poverty allowing banned drugs to be marketed cheaply, non-availability of appropriate drugs, free availability of these drugs and worst, prescribers lacking knowledge, the communication gap between the DCGI and state drug controllers and the prescribers’ lack knowledge and experience. One of the best examples is that of Analgin and Baralgan, which were used rampantly in India. They were banned in 1996 by the Government of India due to their severe side effects. Later in 2012, Analgin was banned and then, this ban revoked in 2016. This often happens, as the side effects appear subsequently and if seen across a larger section of the population, they have to be withdrawn.
With this background, where the efficacy of a drug or vaccine is questioned, when the pharmaceutical company must deal with it at various levels – laboratory, scientific, legal, health and governance – their lobbying knows no bounds or limits. There is strong lobbying even in the absence of a pandemic. So now, imagine, with the intense competition to develop a vaccine and thereafter, to get approvals, how the pharmaceutical companies must have been at it. We have seen vaccine nationalism brewing strongly in the last four to six months.
VACCINE NATIONALISM
As it is, we are seeing scary developments on the social front, regarding nationalism in India. This has been manifest in diet, the celebration of religious festivals, beliefs and political ideologies. Either you are with the dominant Hindu majority regime or you’re not, in which event, you are termed anti-national. Now here comes the scary part. The minute I say I would rather adopt a ‘wait-and-watch’ policy, I am asked, are you an ‘anti-vaxxer’? I may opt for the Oxford vaccine if it is made mandatory. But do we have to take this vaccine? If we take this vaccine, when do we have to take a second shot and for how long is the vaccine effective? Will the shot prevent me from getting Covid? Instead of getting concrete answers to these questions, which every concerned citizen is asking and they should ask, we are being labelled anti-national. The increasing amount of vaccine nationalism being seen across the world is actually worrisome. We saw our Prime Minister rush to the laboratories of companies developing corona vaccine. He visited three cities to take stock of the vaccine development. There is no doubt every government has invested a lot in these vaccines and they have been giving it a huge push. We saw the US President Donald Trump, like Modi, push for the Moderna and Pfizer vaccine. Now, this is being extended to the region. So we have Modi competing with China, which has already begun administering the corona vaccine to its citizens. Now Modi has called for regional diplomacy, to make the vaccine available to all in the South Asian region.
This vaccine nationalism has caused much concern, as many countries have signed up with major pharmaceutical companies to first give their citizens a shot. This obviously means the poorer countries are bereft of the lifesaving jab. The problem is, right now, nobody knows which of these vaccines is the best and which is the most effective. This leads to hoarding, as every country wants to ensure their people get these first. They have hoarded vaccines and it was recently exposed how the UK pre-ordered huge amounts of vaccine, as much as five doses per person. It has been seen in various pandemics, the governments take care of their own interests, instead of global interests, and this nationalist behaviour eventually has an impact on the control and management of the pandemic. This means across the world, millions of poor will remain vulnerable.
In this nationalistic din, the government needs to be held accountable for this one fact: that Bharat Biotech Covaxin has got hasty approval. This has raised eyebrows in the scientific and medical fraternity. Also, on an immediate basis once the vaccination is rolled out, India has claimed it will cover only 300 million citizens. The Indian drug regulator has approved two vaccines for emergency use. The Indian government also plans to export the vaccines. But there is still no clarity on pricing issues, which will prove yet another impediment in the vaccine roll-out.
Till then I would rather continue taking the precautions that I have been doing –wash my hands for over 20 seconds, sanitise doorknobs, use elbows for touching buttons, sanitise parcels, maintain a distance from people and most of all wear masks.
Neeta Kolhatkar is a senior journalist with over 30 years of work experience across different media platforms. She is currently a freelancer and media consultant.
(Views Expressed Are Personal)
As an independent media platform, we do not take advertisements from governments and corporate houses. It is you, our readers, who have supported us on our journey to do honest and unbiased journalism. Please contribute, so that we can continue to do the same in future.
