Supreme Court’s dismissal of PIL on Covid vaccine safety is counter to known science and mathematics

By Bhaskaran Raman*
On 14 Oct 2024, the Supreme Court of India dismissed a Public Interest Litigation (PIL) on the side-effects of the Covid vaccine. In 2021, the world saw the rollout of various Covid vaccine candidates. In India, Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield were rolled out. Covishield was nothing but Oxford’s AstraZeneca relabelled in India.

The importance of open-minded and scientific probe of Covid vaccine safety

In 2020/2021, all Covid vaccines were authorized for emergency use, which meant that the necessary efficacy and safety follow-up was incomplete at that time. The originally approved trials – called randomised controlled trials (RCT) had a “vaccine” group and a “placebo” group for comparison. Such experimental comparison/control is the cornerstone of the scientific method – which even children learn in photosynthesis experiments in class-1. The vaccine trials were scheduled to conclude in late 2022/early 2023. For instance, Covaxin’s trial was scheduled to end in Dec 2022, while Covishield’s trial was scheduled to end in Feb 2023.
In another court case, the government has argued that safety is not of concern now that “Covid is long gone. Vaccination is long over”. Nothing could be further from the truth. The long-term comparison of the two groups “vaccine” versus “placebo” is absolutely essential for answering with confidence, questions such as: “are the increased heart attacks among youth today due to the Covid vaccine or some other reason?” However, none of Covid vaccines (including Covaxin & Covishield) which were originally approved for emergency use, have completed trial results.
The issue of long-term safety is all the more important given that 100+ crore Indians, including tens of crores of children and youth have been administered the emergency use products, although nowhere in the world did children and youth face an emergency due to Covid itself – they were hardly affected by the virus.
Despite the monumental importance however, the Supreme Court gave this issue only a brief few moments before dismissing the PIL without even a hearing. Furthermore, the remarks made by the bench prior to the dismissal are counter to known science and mathematics.

Remarks counter to known science

The bench has remarked “Because of the vaccines, we were able to deal with the pandemic”. Now, the known science behind immunology, which is indeed the basis of vaccines, is that exposure to a virus (weakened in a vaccine or natural) builds robust immunity. As of July 2021, we knew that the majority of Indians had already been exposed to the virus naturally, while only 10% of Indians had been given the vaccines at that time. Therefore the claim of vaccines helping in dealing with the pandemic is counter to known science.
The claim also flies in the face of data from other countries which had wave-after-wave of Covid even after much higher coverage of Covid vaccines. Two stark examples are that of Singapore and Australia, which had no major Covid waves at all, until after 75% of their population had been vaccinated – see graph of data below. More worryingly, both Singapore and Australia have reported record levels of excess deaths in the years following mass Covid vaccination.

The renowned physicist and Nobel Prize winner Richard Feynman once said: “It doesn't matter how beautiful your theory is, it doesn't matter how smart you are. If it doesn't agree with experiment, it's wrong.” The theory of the Indian Supreme Court that the Covid vaccines helped deal with the pandemic may be beautiful and emotionally satisfying, but it does not match with observed data, and hence it is scientifically flawed.

Remarks counter to known mathematics

During the brief proceedings, the bench also checked if the counsel of the petitioner had any Covid vaccine side-effect. When the counsel said that he had not had any side-effect (thankfully), the bench immediately dismissed the case. This reflects a flawed understanding of basic mathematical probability. If the counsel of the petitioner was not affected, it clearly does not mean that the risk of the vaccine side-effect was zero. As an analogy, if a particular smoker does not get lung cancer (thankfully), it does not mean that there is no risk of smoking.
In dismissing the case without even a hearing, the Supreme Court has overestimated the risk of Covid and underestimated the risk of the vaccine. What is the relative risk of death or serious health damage with versus without the vaccine? It is precisely to answer this question that the vaccine trials are conducted. Surely, the Supreme Court is not expected to know such risk-benefit analysis. However, it is expected to know enough to seek expert opinion and ask for the trial results.

The way forward

The dismissal of the PIL by the Supreme Court is thus on flawed grounds. To repeat, none of the Covid vaccines which were originally approved for emergency use, have completed trial results. The Supreme Court should therefore do the right thing and ask the relevant authorities such as the ICMR and the vaccine manufacturers for the completed trial results.
---
*Professor at IIT Bombay. Views are personal

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