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AstraZeneca (Covishield) sued over ‘defective’ vaccine: Some uncomfortable questions

By Dr Amitav Banerjee, MD* 

A couple of lawsuits in the UK high court are making the headlines in the leading British Newspaper “The Telegraph.” These landmark cases revolve around concerns over the adverse effects, including death, from the AstraZeneca Covid-19 vaccine. The lawsuits claim that the efficacy of the vaccine was overrated and the adverse effects downplayed.
The first test case, Mr Jamie Scott, suffered from bleeding in the brain after he took the AstraZeneca vaccine in April 2021 and is now suffering permanent disability due to the injury. He is unable to work. His case is being contested in the UK high court under the Consumer Protection Act of 1987. The litigants, Mr and Mrs Scott, claim that they were told by the government that the vaccine was safe and effective. This was a misleading assurance as the side effects from the vaccine have devastated their lives.
The second case in the UK high court against the AstraZeneca vaccines concerns a more tragic event, death of a young woman, after the “defective” jab. Mrs. Alpa Tailor was only 35 years old and the inquest in her case confirmed that she died due to the vaccine. Her case has been brought to the court by her husband.
Similar litigations are also pending in Indian courts where deaths have occurred due to the Covishield vaccine the Indian name for the AstraZeneca manufactured by Serum Institute of India. In fact the first such lawsuit was filed in India.
Should the Court Cases against the AstraZeneca worry us? During the trials and also early in the mass vaccination campaigns in many countries, there was a cloud over the AstraZeneca vaccine. Anecdotal reports, including a few litigations, cannot be taken as causation, but these cases in the context of patterns observed from large data sets from countries with good health statistics do tell a story which should be investigated with a detached unbiased scientific approach. Alas this has been lacking throughout the pandemic, even during the initial trials of the AstraZeneca vaccine.
Brianne Dressen, a volunteer in an AstraZeneca trial centre in Utah, USA, in late 2020, narrates her experience as scary and permanently disabling. A pre-school teacher in Utah, she never had Covid-19, but received a dose of AstraZeneca vaccine during the trial. Immediately following the jab, her vision blurred, she had difficulty in speaking and ringing in her ears. Her conditions worsened over the next few days with heart rate fluctuations, extreme weakness and feeling like electric currents were passing through her. Prior to the jab she led a very active life and also did rock climbing.
Post jab, she spent most of her time in a darkened room, unable to brush her teeth, or touch her children. The doctor attributed her condition to anxiety. Her husband was desperate to help her. The couple combed the medical literature and tried to connect with other sufferers. They found many victims of the jabs.
In January 2021, the National Institute of Health (NIH), USA enrolled these victims for follow up and investigation. Avindra Nath, the Clinical Director at NIH monitoring them conceded that there was a temporal association between the jab and the severe symptoms but did not commit further. The monitoring faded over the next few months which dismayed the sufferers. Nath defends this by saying that one has to be extra cautious in linking Covid-19 vaccines to complications as the implications for the wrong conclusions are huge. He seems to be suggesting that this will cause vaccine hesitancy.
What the learned doctor overlooks is that in case the vaccines do really cause severe complications, the implications are far more catastrophic – at stake are human lives. A scientific temperament should be capable of holding two diverse possibilities with equipoise – sadly lacking throughout the pandemic.
In addition to the anecdotal reports, big data at population levels show disconcerting patterns. Edward Dowd in his book, “Cause Unknown: The Epidemic of Sudden Deaths in 2021 and 2022,” analyzed all cause mortality since March 2021 after hearing about many anecdotal accounts of vaccine injury. He noticed a spike in sudden deaths in the working age cohort aged 25 to 44 years coinciding with the vaccine mandates for work; 61, 000 Americans died between March 2021 and February 2022. These figures were corroborated by studying insurance claims.
Whether vaccine is causing this phenomenon or is it due to “long covid?” Population level data from South Australia can help us make an intelligent guess. Unfortunately, they are not reassuring. Being a small sparsely populated region, the state could, with stringent measures, ensure almost zero covid status before the mass vaccine rollout.
By December 2021 it had only about 1,000 Covid-19 cases. After the rollout of mass vaccination it had 2,172 cardiac events among the young between 15-44 years, a 67% rise. And across all age groups, it had 37% increase in cardiac events after mass vaccination. The irony lies in much higher cardiac events in young people who had the least indication for vaccination.
Since 90% Indians got Covishield, is it going to be a lost vaccine war, a Shakespearean tragedy?
Another report from Australia which should concern India is the higher rates of adverse events associated with AstraZeneca compared to the mRNA vaccines. Western Australia’s Vaccine Safety Surveillance Annual Report 2021, shows a dramatic rise in AEFI following mass roll out of the Covid-19 vaccines in February 2021. The rates of AEFI following Covid-19 vaccines were almost 24 times higher compared to other vaccines. While AEFI following non-Covid-19 vaccines occurred in 11.1/100,000 doses administered, in case of Covid-19 vaccines AEFI occurred in 264.1/100,000 doses.
This by no stretch of imagination can be called acceptable. The rate of AEFI was highest for AstraZeneca (Covishield) at 306/100,000 doses. This is of particular relevance for India where Covishield was the main vaccine administered. Due to our poor vaccine adverse events reporting system we do not have similar figures for our country. This absence of evidence will tend to be taken as evidence of absence of AEFI. Perhaps this might be the reason why use of Astrazeneca/Covishield was suspended in many European countries which had better reporting systems for AEFI.
“The use of AstraZeneca Covid Vaccine was suspended in a number of European countries in early 2021 because of the link to serious side effects, so it is strange that India did not halt its use also,” Dr Aseem Malhotra, a person of Indian origins and an eminent British cardiologist of global fame, had cautioned in February 2023, during his visit to India to attend an event organized by Universal Health Organization (UHO), which is a watchdog on evidence based medicine.
What is most poignant is that the adverse events seem to be affecting the young more than the old. The irony is that the young and healthy never needed the vaccine in the first place and few unfortunate among them are paying the price for irresponsible public health decisions.
Serosurveys have established that up to the age of 69 years the infection fatality rate from Covid-19 is around 0.05%, and in healthy children it is almost zero. India has a young demographic profile. Only about 3% of our population is over 70 years and vulnerable to severe Covid-19. Serosurveys in various parts of the country had established that almost 80% of our young people had already recovered from the natural infection, before rollout of mass vaccination in children below 18 years. Natural infection confers more robust immunity than the vaccine.
A combination of youth and protection after natural infection conferred a strong shield against the virus. There was no science or logic for vaccinating them. While the government in its Supreme Court affidavit has claimed that there were no vaccine mandates in the country, a recent peer reviewed study has brought out that there was an environment of coercion, stigma and shaming which made an appreciable number take the vaccine against their will.
Should we worry? Since 90% Indians got the AZ (Covishield), is it going to be a lost vaccine war, a Shakespearean tragedy? Did we run a "defective" superfast train on old rickety tracks given our poor monitoring of side effects and lack of health infrastructure? These are some uncomfortable questions.
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*Epidemiologist, presently Professor in a Medical College at Pune. He had served as an epidemiologist in the armed forces for over two decades. He recently ranked in Stanford University list of world’s top 2% scientists. He has written the book, “Covid-19 Pandemic: A Third Eye”

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