Part 1: Was Corona Vaccination Evidence-Based?
Varthabharati English 28 May, 2024
https://english.varthabharati.in/india/was-corona-vaccination-evidence-based
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 vaccines 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 Corona virus? 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 corona virus, 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 corona virus 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 corona virus 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!
Part 2: Were the Corona Vaccines Proven to be Safe?
Varthabharati English 29 May, 2024
https://english.varthabharati.in/india/were-the-corona-vaccines-proven-to-be-safe
Ever since the vaccine maker Asta Zeneca’s admission before the UK court, the issue of severe adverse effects of corona vaccines has come to the fore again. The medical professionals who had brushed off the adverse effects as negligible and encouraged people to get vaccinated are now forced to justify their position. Were the side effects of these new vaccines indeed negligible?
Even when Covishield vaccine was given emergency use authorisation in India, there were early reports of possible side effects of the vaccine. In about a week after the vaccination was started on January 16, 2021 for doctors and health workers, there were reports of about 10 deaths among vaccine recipients, and some of us had raised the issue of safety of this vaccine and had questioned the rationale of using it without enough studies. In an interview to the periodical Mangalore Today in January 2021, I had pointed out these reports of at least ten deaths due to heart attacks and strokes after the vaccination and had called for investigations to know whether these deaths were related to the vaccine. By February-March 2021, there were reports of 5 deaths due to blood clotting and low platelet count (thrombotic thrombocytopenia) in Denmark, where 130,000 people (1 death in 26,000 recipients) had already received the same vaccine. Considering this, on March 11, 2021, Denmark and Norway stopped the use of this Oxford (Covishield) vaccine. Soon thereafter, Sweden and England, the parent countries of the makers of this vaccine, Astra-Zeneca and Oxford University, and also some other European countries as well as Australia either stopped the use or limited it to adults only. By the time Covishield vaccine was introduced to the general public in India in April 2021, all these reports were available, and we too had brought them to the attention of the government. When the Minister of Higher Education in Karnataka enforced corona vaccination as mandatory for entering colleges in Karnataka in May-June 2021, I had sent a legal notice to him stating that this vaccine had been withheld from being given to students and the young in other countries. This fact was also stated in the public interest petition filed in the state high court in June 2021. But all these warnings went unheeded and our students and youth were vaccinated. People were encouraged to get three doses without any need or basis. Reports of side effects in vaccine recipients were ignored and denied. Those who warned about these adverse reactions and unscientific methods were berated. Even though it was officially said that vaccination was optional, everyone was pressured to get vaccinated under the garbs of nationalism, sectarianism, and obedience of government orders etc. With all these, over 95 crore Indians were vaccinated.
Since the beginning of Corona vaccination, many reports of side effects have been published. A report of a multinational study on COVID 19 vaccines and adverse events of special interests was published on April 2, 2024. [Vaccine, 2 April 2024;42(9):2200] In Europe (Denmark, Finland, France, Scotland), Australia, New Zealand and Argentina, 21,97,37904 doses of mRNA vaccine and 2,30,93399 doses of Oxford (Covishield) vaccine were administered. Side effects observed within 42 days of administration were analyzed in this report. There was a statistically significant increase in Cerebral venous sinus thrombosis (OE ratio = 2.49) and Guillain-Barré Syndrome (OE ratio = 2.49) after a first dose of ChAdOx1 (Oxford) vaccine and myocarditis (OE ratio = 3.48) and acute disseminated encephalomyelitis (OE ratio = 3.78) following the first dose of mRNA-1273 vaccine. Notably, the study did not include data from India, where 175 crore doses of the Oxford vaccine were used, and it also lacked information on long-term side effects.
Vaccine induced thrombosis and thrombocytopenia (TTS) has been reported only with Oxford (Covishield) and Janssen vaccines. Studies from other countries estimated the incidence of TTS from 2 to 16 cases per million doses, which was higher among those who received the Oxford vaccine (npj Vaccines. 2022;7:141). What’s more, these studies have reported that TTS occurs in 1 per million in those over 65 years of age, 3 per million in those aged 55-64 years, and 1 in 20,000 to 60,000, i.e. 17 to 50 per million, under 55 years of age. In other words, among those under the age of 55, infection fatality was 3 to 20 per million, while vaccine induced TTS was 17 to 50 per million; meaning that in people under 55, the vaccine was more riskier than the infection, and the infection was less riskier than the vaccine. In the age group of more than 60 years, infection fatality was 60 per million, vaccine induced TTS was one per million, making the vaccine safer than the infection. When it was known in Denmark in March 2021 that one in 26000 had died from the Oxford vaccine and that the vaccine was immediately withdrawn, why was there a need to give that vaccine to everyone in our country?
In India, comprehensive and accurate data about adverse events following immunization (AEFI) are not available and it is not even clear whether such information has been recorded honestly. If TTS has occurred in India at the same rate as elsewhere in the world, about 22,000 cases of TTS and related deaths might have occurred here. According to Awaken India Movement, which has actively collected and published information about AEFI, there have been 19273 deaths recorded in connection with COVID vaccination, but authenticity of this data cannot be verified. According to the official information provided by the government in Parliament, Supreme Court of India and under the Right to Information Act, out of a total of 219.6 crore doses of vaccines administered in our country, 92114 (0.0042%) cases of AEFI were recorded, of which 2782 were serious, and 1148 deaths occurred, 90 per cent of the doses and 92 per cent of the deaths were of Covishield. In Canada, Brazil and Argentina, AEFI were recorded in 0.06 per cent of vaccinees, whereas in India it was 10-15 times lower, suggesting that AEFI were possibly not recorded properly here.
Cases of blood clotting due to Covishield have not only involved the cerebral veins, but also there have been reports of blood clots in the veins and arteries of the intestines, retina, limbs, etc., and neurological complications such as Guillain Barre syndrome and cardiac complications such as myocarditis have also been reported. As the vaccines were given emergency use authorization on the basis of hasty and short-term trails of only a few weeks, without any studies on long term adverse effects, neither the doctors nor the general public had enough information about the possible adverse effects. Therefore, even when such adverse events did occur following vaccinations, they were not attributed to vaccines, or were deliberately rejected as unrelated to vaccines, and were not recorded as AEFI. For this reason, it cannot be ruled out that the actual number of people who suffered AEFI due to Covishield and other vaccines may be many times higher than what has been recorded.
As early as March-April 2021, scientists in Denmark had identified that some special antibody produced against the Oxford (Covishield) vaccine may be responsible for TTS. Both Oxford (Covishield) and Janssen vaccines are recombinant vaccines, using adeno viruses (of chimpanzees and humans) as vectors for the corona virus spike protein gene, and have been shown by many studies to produce antibodies against platelets (anti-platelet factor 4 antibody), resulting in thrombosis and thrombocytopenia. A recent study conducted at Flinders University in Australia has also reconfirmed these findings. Some studies have shown that although these antibodies disappear within 40-50 days in most people (about 85%), some may persist even after six months, and in 3-9% the risk of thrombosis may persist for a long time (Journal of Clinical Medicine. 2024;13(4):1012) Whether the increasing cases of sudden cardiac arrest, heart attack and stroke are related to TSS and vaccine induced antibodies cannot be answered without further studies.
For Covaxin, which was given emergency approval without phase III trials, ‘under clinical trial mode’, neither the final report of phase III trials nor of AEFIs have been published so far. A few days ago, experts from Banaras Hindu University published a report that 70% of those who received Covaxin experienced adverse effects. The ICMR warned the Banaras University that the study was flawed and sought removal of its name from acknowledgments. Questions to ICMR and Bharat Biotech to show a better study has remained unanswered so far!
It is therefore time now for our government, doctors, medical organizations and vaccine manufacturing companies to give honest, evidence-based answers to our 95 crore people who were inadequately informed and pressured to get vaccinated unnecessarily. After the Astra Zeneca company admitted the adverse effects in court, a doctor from Karnataka, speaking to the media, compared the corona vaccine to a bus-train journey, and stated that just as people travel in buses-trains-airplanes even after being aware of the risks of accidents, vaccinations too can be associated with risks and these risks need to be taken, considering the benefits of the vaccines. But the fact is that for the real bus or train alluded to by this doctor, passengers buy the tickets on their own volition, and board them on their own after knowing fully well the risks of accidents. The covid vaccine bus, on the other, was touted as very safe, and without informing anyone much about any risks involved, it was as if the government and these doctors pushed our people into it for free travel, and now, after 2 years of travel, are scaring the passengers, travelling forcibly, that it can meet with accident leading to serious injuries. Doctors who forced our people to get vaccinated, and are now struggling to justify it, need to know the difference between these two buses.
Part 3: Corona Vaccination: What Next?
Varthabharati English 31 May, 2024
https://english.varthabharati.in/india/corona-vaccination-what-next
After vaccinating 95 crore people against COVID, without any evidence-based indications, without adequately informing them about the possible adverse effects, when several reports and admissions about serious adverse effects of these vaccines are emerging from studies all over the world and from vaccine manufacturers, and when cases of sudden cardiac arrest, heart attacks and strokes are being reported everyday from everywhere, naturally, anxiety and fears are increasing among those who have been vaccinated, but comforting answers are nowhere to be found.
It is urgently necessary for the government, doctors and vaccine companies who promoted and injected the vaccines in haste to do the needful to minimise the possible adverse effects and to alleviate the concerns of the people.
First of all, it is of utmost importance to place before our people all the details about the benefits and problems of corona vaccines, transparently and convincingly. In India, COVID related tests, hospitalisations, deaths and vaccinations have all been linked with personal Aadhaar numbers (whether it was right or wrong to do so is another matter), making it therefore easy to correlate these. Such analyses should be conducted and their reports should be made available to the public immediately. How many people who were previously infected were given the vaccine, how many people got infected after getting the vaccine, how many people who got the vaccine got infected thereafter and developed complications or died because of COVID, and all information on AEFI – incidence, recovery, disabilities, deaths etc., should be analysed and transparently published. The final reports of phase 3 and phase 4 trials conducted in India on Covishield and Covaxin vaccines should also be published immediately.
Second, incidence of thrombosis and thrombocytopenia syndrome, and of cerebral venous sinus thrombosis, splanchnic vein thrombosis, deep vein thrombosis, pulmonary embolism, thrombosis in retinal vessels, Guillain Barre syndrome etc., and their relationship to corona infection and corona vaccination must be studied and the reports must be published.
Thirdly, studies about the prevalence of anti-platelet factor 4 antibodies must be conducted in at least three to four thousand people, in sub groups such as Covishield vaccinated, Covaxin vaccinated, unvaccinated, and among these three groups, Corona infected and uninfected. Also, studies should be conducted to examine anti-platelet factor 4 antibodies in cases of cerebral venous sinus thrombosis, splanchnic vein thrombosis, deep vein thrombosis, pulmonary embolism, thrombosis in retinal vessels, heart attacks, sudden cardiac arrests, and strokes. Since these studies are difficult, complex and costly, they can be conducted in premier institutes like AIIMS, Jayadeva Heart Institute etc., independently in collaboration with ICMR. Unless such studies are conducted honestly, there will be no evidence that Corona vaccines are safe or that vaccines are the cause of all the serious problems mentioned above.
Fourth, the government should be compassionate and provide appropriate compensation to those who have suffered serious complications and died from vaccine-related adverse effects that have already been confirmed.
Fifthly, with all the emerging evidence and court admissions, it is baseless and even dishonest to deny and refuse to register the adverse effects due to Corona vaccines. It is also futile to try and justify this vaccination, claiming it as absolutely essential and the adverse effects as negligible. Instead, our people must be told the truth and comforted.
What can the vaccinated do?
It is not possible to extract the vaccine that has been injected into the body unnecessarily. One also cannot keep worrying about the adverse effects that have now been admitted to, nor about the increasing reports of sudden cardiac arrests and other vascular events. It is also fruitless to be frustrated that the government, vaccine makers and medical fraternity are not forthcoming with reliable information and solutions to these concerns. Therefore, the general public who have been vaccinated should focus on protecting their own physical and mental health.
It was known at the beginning of the corona pandemic that the new corona virus and COVID increase inflammation in our body, and act on ACE2 receptors which are closely linked to the regulation of blood sugar level, metabolism, blood pressure, inflammation and blood vessel health. For the same reason, it was clear that COVID could get worsened and complicated in people with modern diseases like diabetes, high blood pressure, obesity, heart disease, and that these diseases could also get worsened due to COVID. Since the covid vaccines also contain the spike proteins of the corona virus that act on ACE2 receptors, and since these vaccines have been given to those already infected, the possibility of effects on all these diseases and vice versa needs to be considered. In addition, it is clear that these modern diseases are intimately related to modern diet, lifestyle, and daily stressors, all of which can be aggravating each other. Lockdowns, closure of schools, colleges and offices and work-from-home, closure of stadia, gymnasia, other sporting activities, shut down of communities that stopped daily walking and other exercises, and other such mindless measures during the corona pandemic led to unhealthy changes in diet, cut down physical activities, and worsened mental stress. All these could have compounded the vicious cycle of metabolic diseases, covid, and vaccination induced adverse events.
As the lock downs, masks etc. failed and almost everyone in the country has been infected with corona virus and except for the small children, more than 90 percent people have been vaccinated against Corona, it is not possible to completely eliminate the possible consequences of these. But it is possible to reduce the risks of thrombosis, heart attacks and strokes, and everyone should make that effort. Good control of diabetes and high blood pressure, avoiding foods and lifestyles that cause and worsen these diseases and also obesity and inflammation, brisk walking or swimming for 30-60 minutes a day, adequate rest, relaxation and at least 7-8 hours of sleep at night are essential. Avoiding animal milk and dairy products, sugar and sugary/sweetened foods and beverages, fruits and fruit juices, processed and fast foods, avoiding alcohol, and smoking can all help protect heart and blood vessel health.
Persons with coronary artery disease tend to have premonitory symptoms before suffering a heart attack, which should not be ignored and appropriate tests should be done. Sometimes even the doctor may not take these complaints seriously, in which case the person with the problem may have to force the doctor to do the relevant tests. Coronary artery disease results in compromised blood flow to the cardiac muscles and the person feels difficulties during exertion which can manifest differently. On walking, climbing stairs or heights, playing, etc , the person may have a feeling of strangulation, tightness, pressure, or heaviness in the chest, burning or bloating in the upper abdomen, pain or a pull over the neck, shoulders, lower back, lower jaws or upper back, difficulty breathing, palpitations, or dizziness. If any of these symptoms occur while doing any work, and if they recur every time one does such work, it is a good idea to get tested for coronary artery disease. Sometimes an ECG alone may not reveal the diagnosis in people with underlying coronary artery disease; therefore, if there are obvious symptoms and no abnormalities on the ECG, a treadmill test or angiogram may be needed.
Treatments to cleanse or detox the body of the vaccinated, or tests for assessing the risks of thrombosis etc., are neither available nor recommended nor needed.
Due to the inhumane and unscientific measures during COVID pandemic and corona vaccination, the masses have lost faith in modern medicine and the medical profession, and the medical fraternity is more to blame than the government and the vaccine companies. If modern medicine and the medical profession are to regain and retain people’s trust, there is an urgent need to admit the mistakes of the corona period and honestly present scientific, evidence-based information about the vaccine to the people. All doctors need to know that a doctor’s commitment should be to medical science, the good of the people, and the truth, and not to any government, political party or leader, or any drug or vaccine company. That is the lesson to be learnt from the mistakes committed during corona infection and corona vaccination.
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