Was Corona Vaccination Evidence-Based?
Part-1
New Delhi: A few weeks ago, AstraZeneca, the company that developed the ChAdOx1-S/nCoV-19 [recombinant] vaccine, 175 crore doses of which were given in India under the name Covishield, admitted in a London court that its vaccine could have caused blood clots, heart attacks, and strokes, and later, on May 5, 2024, said it was withdrawing that vaccine. People who have lost their loved ones due to side effects or who have suffered serious or permanent disabilities are filing lawsuits against the makers of COVID vaccine companies in many parts of the world seeking compensation. Such cases have also been filed in India in the past and the statement by AstraZeneca has added new momentum to these complaints.
As the company acknowledged the serious consequences of the vaccine, the anxiety, suspicion and anger of those who had received the vaccine have increased further. While the government that gave the vaccine and the company that produced and sold it have remained silent, the doctors who supported and encouraged the vaccination are now struggling to offer justifications.
Was COVID-19 the worst, deadliest infection ever? Could the highly contagious corona virus have been prevented by a vaccine? Was it appropriate to vaccinate while the Corona infection was rapidly spreading? Was it necessary to vaccinate even those who had already been infected with the new Coronavirus? Was it necessary to vaccinate young and healthy adults? Was there clear evidence about the safety of new corona vaccines?
If the answer to all these questions is ‘yes’ then it was right to give the vaccine, if the answer is ‘no’ then the vaccine should not have been given.
Was COVID-19 the worst, deadliest disease? No, and that was known in January 2020 itself, within two months of the spread of SARS CoV2 virus. It was by then estimated that the risk of death from the new corona infection could be 3 to 20 per million among those under the age of 50, and more than 60 per million for those over 50 (this estimate was so accurate that deaths from COVID in 38 countries before the vaccines were introduced were less than a third of this initial estimate!). Only on the basis of such estimates some of us had argued that young adults did not need any vaccine at all as the chances of serious problems from corona infection were expected to be very low in that age group. But ignoring all the evidence, everyone from children to the elderly was given the vaccine. Covishield and Covaxin were given to those above adolescence, and Corbevax vaccine, which was not used elsewhere, was given emergency use authorisation for vaccinating younger children.
Instead of answering whether a vaccine could prevent the transmission of coronavirus, which easily spreads from one to six people through inhalation, many new narratives were created. Initial reports claimed that the Corona vaccines are 78 percent effective against symptomatic infection, 86 percent against hospital and ICU admissions, and 87-100 percent against death. But as days rolled by, these positions changed, and it was stated that the vaccines cannot be guaranteed to prevent infection, and more new vaccines may be needed as new variants evolve. In the same breath, it was also stated On the back of that, the vaccine will prevent the spread of corona, it was continued to be said that everyone should be vaccinated, and this was escalated further to the extent that the media and else started campaigning that those who were not vaccinated would endanger the entire community, children who could not be vaccinated would be a danger to teachers, so schools should be closed, those who were not vaccinated should not travel anywhere, should not be allowed to enter anywhere, not even to go to playgrounds, schools, or even hospitals, not work as nurses, in general, it was portrayed as though the unvaccinated were sociopaths, had no right to live, and were ostracised, fired from jobs, even arrested. In India, within days of the vaccination drive for the public from April 2021, instead of decreasing, the spread of Corona started to rise again, hitting as the second wave, proving the futility of vaccination as a measure to control transmission of SARS CoV2.
Was it appropriate to vaccinate while the Corona epidemic was spreading rapidly? It was for the first time in human history that a vaccine for a highly contagious, minimally harmful coronavirus was developed in haste, and given to everyone while the infection was spreading, even though it was not guaranteed to prevent infection. It is not easy to understand the logic behind the grand plan to vaccinate hundreds of crores of people with two doses of vaccine to prevent an infection that spreads easily to one to six people from an infected person! Whatever, the virus infected everyone much faster than the vaccine, and even for the already infected individuals, the vaccine was also injected!
It is common knowledge that infection with any virus, including Corona, confers lifelong immunity. In India, by December 2020 the central government had said that 40 percent of the people had been infected with Corona, and the Hon'ble Prime Minister had announced on January 18, 2021 that India had successfully won the war against Corona. If that was indeed the case, we asked, what was the need to vaccinate 40-60% of Indians who had developed immunity against infection? In natural infection, with the body being exposed to innumerable viral particles, strong immunity is produced against all 29 proteins of the virus, and antibodies are developed against not only its spike protein, but also against other proteins, whereas, following vaccination, our body gets exposed to a limited amount of selected viral particles, spike protein alone in the case of SARS CoV2, and develops limited immunity, that too unproven. Despite these facts, a new argument was floated all over, without any evidence, that the new Corona vaccines would provide stronger protection than the natural infection! Although it was clearly established that the vaccine did not prevent infection or provide better and longer immunity from the original strain or variants, or re-infection, even those who had recovered from the infection were pushed into vaccination even though it was clearly established that those already infected had good, long-term immunity and the chance of re-infection was very small.
By the time the Corona vaccine was available, a year's experience with Corona infection was available globally, including in India. By then it was clear that there were no complications in younger and healthy adults. Therefore, many of us opposed the plans to vaccinate all such people. In our country 85 percent of people, or 115 crore people, being below the age of 50, would not have needed this vaccination. Even among the remaining 20 crore people above that age, if 40 percent had already been infected and recovered, vaccination would not have been necessary. Excluding these, only about 12 crore people above the age of 50, and those above 35 years of age with problems such as obesity, diabetes, heart disease etc. would have required the vaccination, if at all. We also filed a public interest petition in the state high court questioning the statement of the then higher education minister Ashwathanarayan that students who had not been vaccinated could not come to college from June 2021. But the government did not consider any of these, and most of the doctors also mocked and opposed.
There was no clear evidence that the new corona vaccines were safe. After the new coronavirus was identified in December 2019, the viral genome sequence was identified and published by Chinese scientists on January 12, 2020. Immediately thereafter the race for making a vaccine against it also began, and many types of vaccines were prepared using technologies that had not been used until then. According to the US CDC, it takes at least 10-15 years for a vaccine to be developed, tested in three phases, approved and put into use. But the new corona vaccines were developed in just six months, tested in just a couple of months, without much studies on safety and long-term side effects, and were given emergency use authorizations, all within one year.
The first vaccines from China and Russia arrived in July-August 2020. By the end of December 2020, the vaccine developed by Oxford University and AstraZeneca was approved by European countries, and vaccination soon started in countries like England and Denmark. Serum Institute of India, the largest vaccine manufacturer, obtained the licence from AstraZeneca to produce the same vaccine and offer it in India under the name of Covishield. India's own Bharat Biotech company developed its own vaccine (Covaxin) in collaboration with ICMR and went for approval. Our government, caught up in the vaccine race, hastily held meetings in early January 2021 and approved the emergency use of both of these vaccines even before reports of the studies done in our country were available.
When EUA was given to Covishield, reports of tests conducted in India hadn’t been published and the EUA was given on the basis of studies conducted in Britain, Brazil and Africa. For Covaxin, EUA was given in ‘clinical trial mode’, after only phase 2 trials, under the pretext of ‘the need for such a vaccine to control a British variant’, and the vaccine recipients were to be the subjects of its phase 3 trials!
The emergency use authorisation for these two vaccines was questioned and opposed by many experts, and the owners of those vaccine companies had a public spat. While Aadar Poonawala of Covishield pooh-poohed Covaxin, stating it was nothing more than water, Krishna Ella of Covaxin termed the studies on Covishield as poorly designed and stated that it had side effects in 60-70% of recipients! Senior vaccine scientist Dr. Gagandeep Kang declared her refusal to take either of these two vaccines, pointing out that reports of the trials conducted in India on Covishield hadn’t been published, nor any information was available on Covaxin. Senior virologist Dr. Jacob John declared that he won't take Covishield due to reported side effects. Senior immunologist Dr. Vineeta Bal termed it unethical and Hitlerian to start using vaccines without evidence of their ability to prevent infection. Senior virologist Dr. Shahid Jameel questioned the manner in which these vaccines were given authorisation. Dr. Soumya Swaminathan, chief scientist of the World Health Organization, said that universal use of vaccines couldn’t be allowed until the minimum standards of efficacy and safety were guaranteed. (I wrote all this in an article titled 'Is there an urgent need for a vaccine for a non-emergency corona infection?' published in Varthabharati on January 15, 2021). After a few months, most of them quietened down or changed their positions, even the fight between the vaccine makers went cold!
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Dileep case: Advocate representing survivor alleges Judge favoured actor
Thiruvanthapuram: A month after Malayalam film Actor Dileep was acquitted in the the case pertaining to abduction and rape of a famous Malayalam actress, Advocate T B Mini, the survivor's counsel in the case has accussed the Ernakulam Principal Sessions Court Judge Honey M Varghese of favouring Actor Dileep in her petition to the Chief Justice of the Kerala High Court, reported On Manorama.
In her petition(accessed by Onmanorama), Mini has sought contempt of court proceedings against Honey Varghese alleging that the trial court judge made derisive remarks about her, including claims that she would doze off during court proceedings and was lax in handling the actress assault case.
Mini, who described the comments as false, contemptuous and defamatory, alleged in her petition that Honey Varghese had unduly favoured Dileep, the actor and producer who was the eighth accused in the case.
In the verdict delivered in December last year, Judge Honey Varghese acquitted Dileep and three other accused while sentencing six convicts to imprisonment.
The ruling drew major uproar, while Mini had refrained from making any public remarks against the judge at the time, stating only that the verdict was disappointing, now she has levelled serious allegations against the judge as the High Court is set to begin hearing the bail pleas filed by the six convicts on February 4.
Furthermore, Mini has stated in her petition that since the very first stage of the trial, the Judge Honey Varghese passed derogatory remarks against the survivor and behaved discourteously towards the prosecution, which eventually led to the resignation of two Special Public Prosecutors. According to Mini, the undue favour shown by Honey Varghese to Dileep resulted in a serious miscarriage of justice and brought disrepute to the judicial system.
She stated in the petition that it was a regular practice of Honey Varghese to pass derogatory comments about the survivor as well as the prosecution witnesses.
Mini also alleged that on several occasions, the Special Public Prosecutor was compelled to remind the judge that such conduct was in violation of the Supreme Court’s directions.
Mini also questioned the manner in which Honey Varghese conducted the inquiry into the illegal access of the memory card containing visuals of the sexual assault.
The memory card, a vital piece of evidence kept in the custody of the Sessions Court, was unlawfully accessed and tampered with, leading to a change in its hash value.
According to the report, an examination by the State Forensic Science Laboratory found that the card had been accessed on January 9, 2018, December 13, 2018, and July 19, 2021, while it was under the safe custody of different courts.
Mini stated in the petition that the memory card was illegally accessed for nearly half an hour in July 2021 while it was in the custody of the court presided over by Honey Varghese.
After the survivor approached the High Court citing a breach of privacy, the HC directed Honey Varghese to conduct an inquiry. Mini alleged that the judge carried out only a perfunctory inquiry, in violation of the High Court’s directions.
Mini has sought legal action against Honey Varghese, stating that when a lawyer is defamed in open court through false allegations, the judge is liable to face proceedings before the High Court. She noted in the petition that although she had a very limited role in the trial as the survivor’s counsel, she regularly attended the proceedings from November 2022 onward.
