By Kamal Pratap Singh, Managing Editor, Biotech Express E-mail- kamal9871@gmail.com
Finally, AstraZeneca has accepted in UK court that it’s vaccine could have caused blood clots in rare cases. The word rare here has been cautiously used to show that the numbers of events are negligible.
In court documents from February, AstraZeneca denied that “TTS is caused by the vaccine at a generic level”. However, it admitted to the possibility of TTS as a result of its vaccination in “very rare cases”.
Biotech Express probably is the only magazine around the world which has covered all news of adverse events and draconian measures adopted to vaccinate even when it was for emergency use and COVID 19 mortality was less than 1%. This is evident from the timeline of articles that can be searched using keywords “Covishield” on the website www.biotechexpressmag.com
ASTRAZENECA, the pharmaceutical giant which is the second highest taxpayer in UK virtually became a household name during the Covid-19 pandemic. When sued in a class action over claims that its vaccine, developed with the University of Oxford, caused death and serious injury in dozens of cases has admitted that its COVID-19 vaccine could cause rare side effects, including blood clots and low platelet count termed as TTS (Thrombosis with Thrombocytopenia Syndrome).
Although COVID vaccine manufacturers have contesting these claims from a long time, the court submission marks the first time ASTRAZENECA has admitted that the vaccine can cause side-effects.
According to the Council for International Organisations of Medical Sciences, “very rare” side effects are those reported in less than 1 in 10,000 cases.
The scientists have named blood clots after vaccine as Vaccine Induced Thrombosis with Thrombocytopenia (VITT) on which research was started immediately after the jab was released. The earliest case of VITT came to light in year 2020 itself in India and in UK.
In India a Chennai volunteer for the third phase of the Covid Oxford vaccine trials dose on October 1, 2020 immediately alleged of adverse effects and suffering from neurological and psychological issues as a result of taking the dose. He asked for 5 Crore compensation but SII in return filed a Rs 100-crore defamation suit and called the volunteer’s allegations “malicious and misconceived”.
In UK, Fifty-one cases have been lodged in the High Court, with victims and grieving relatives seeking damages estimated to be worth up to £100 million. The first case was lodged last year by Jamie Scott, a father of two, who was left with a permanent brain injury after developing a blood clot and a bleed on the brain that has prevented him from working after he received the vaccine in April 2021. The hospital called his wife three times to tell her that her husband was going to die.
Kate Scott, Mr Scott’s wife, told the Telegraph: “The medical world has acknowledged for a long time that VITT was caused by the vaccine. It’s only AstraZeneca who have questioned whether Jamie’s condition was caused by the jab. “It’s taken three years for this admission to come. It’s progress, but we would like to see more from them and the Government. It’s time for things to move more quickly.
She added, “I hope their admission means we will be able to sort this out sooner rather than later. We need an apology, fair compensation for our family and other families who have been affected. We have the truth on our side, and we are not going to give up.”
Lawyers representing families suing the drugs company argue that the vaccine was not as safe as individuals were entitled to expect. They are suing the firm under the Consumer Protection Act 1987.
Mr Scott’s lawyers have argued that he suffered “personal injuries and consequential losses arising out of his sustaining vaccine induced immune thrombosis with thrombocytopenia (VITT) as a result of his vaccination on 23 April 2021, with the AstraZeneca Covid-19 vaccination”.
Lawyers argue that the AstraZeneca-Oxford vaccine is “defective” and that its efficacy has been “vastly overstated” – claims AstraZeneca strongly denies. Lawyers for the claimants argue that VITT is a subset of TTS, although AstraZeneca does not appear to recognise the term.
AstraZeneca vaccine was used in India under the brand name Covishield which has raised concerns on this too. Covishield was developed by the British-Swedish company in collaboration with Oxford University, and produced by the Serum Institute of India for India. It was widely administered in over 150 countries.
In the months after the rollout, the potentially serious side effect of the jab was identified by scientists. It was then recommended that under-40s be offered an alternative jab because the risk of the AstraZeneca vaccine outweighed the harm posed by Covid.
Lawyers representing families suing the drugs company argue that the vaccine was not as safe as individuals were entitled to expect. They are suing the firm, based in Cambridge, under the Consumer Protection Act 1987.
Mr Scott’s lawyers have argued that he suffered “personal injuries and consequential losses arising out of his sustaining vaccine induced immune thrombosis with thrombocytopenia (VITT) as a result of his vaccination on 23 April 2021, with the AstraZeneca Covid-19 vaccination”.
Scientists first identified a link between the vaccine and a new illness called vaccine-induced immune thrombocytopenia and thrombosis (VITT) in March 2021.
Then, in March 2021, the European countries France, Germany, Italy, Netherlands, Denmark, Norway, Iceland, Austria, Estonia, Bulgaria, Romania, Estonia, Lithuania, Luxembourg, and Latvia temporarily paused the use of the AstraZeneca vaccine after a few cases of blood clotting were reported.
The following month, the World Health Organisation (WHO) said TTS was being reported in some cases after vaccinations with Covishield and Vaxzevria (which was the other trade name for AstraZeneca’s vaccine).
Withdrawal
AstraZeneca has announced that the vaccine is being removed from markets for commercial reasons. It further stated that the vaccine is no longer being manufactured or supplied, having been superseded by updated vaccines that combat new variants. The application to withdraw the vaccine came into effect on May 7.
The vaccine can no longer be used in the European Union following the company’s decision to withdraw its “marketing authorisation”.
Similar applications will be submitted in the UK and other nations in the coming months that have given the go-ahead to the vaccine, known as Vaxzevria.
AstraZeneca has insisted that the decision to withdraw the vaccine is not related to the case or admission that it can cause TTS and termed the timing a pure coincidence, according to The Telegraph report.
Dangers
A range of symptoms are associated with TTS, including breathlessness, pain in the chest or limbs, pinhead-size red spots or bruising of the skin in an area beyond the injection site, headaches, numbness in body parts, etc. TTS could mean a restriction in the flow of blood due to clotting.
The website of Johns Hopkins Medicine says, “Thrombosis can block the blood flow in both veins and arteries. Complications depend on where the thrombosis is located. The most serious problems include stroke, heart attack, and serious breathing problems.”
In 2023, the WHO incorporated vaccine-induced immune thrombotic thrombocytopenia (VITT) into its classification of TTS.
Science of VITT
Eichinger was among the first to notice the clotting disorder, a strange combination of blood clots—which can be dangerous, and potentially fatal, if they block blood flow to the brain or lungs—and a counter-intuitive deficiency of cell fragments called platelets that promote clotting. The clots also appeared in unusual parts of the body, such as the brain and abdomen, rather than in the legs, where most deep-vein blood clots form.
This rang alarm bells for Eichinger, who had previously encountered a similar phenomenon in a few people who had been treated with the blood-thinning drug heparin. Heparin is normally used to prevent clotting, but in very rare cases can trigger a syndrome called heparin-induced thrombocytopenia (HIT), which causes blood clots together with low platelet levels.
By 22 March, the EMA had assembled 86 reports of people who had experienced blood clots in the brain or abdomen within two weeks of receiving a dose of the Oxford–AstraZeneca vaccine. Some of these cases have been confirmed to bear the hallmarks of HIT, even though these people had not received heparin.
In just two and a half years, doctors and scientists around the world have begun to unravel the secrets of VITT. They found a protein called platelet factor 4 (PF4). In the course of infection, many people make antibodies that stick to PF4 as part of the immune response, but these antibodies usually stick weakly.
In VITT, antibodies form that can stick to PF4 like superglue. The antibodies in VITT glue PF4 molecules together, forming large structures known as “immune complexes”. These complexes bind to and activate small cells called platelets that are vital for blood clotting. Normally, platelets float around in the blood in an inactive state, but once activated they spread out, get very sticky, and spew out hundreds of different chemicals.
In VITT, platelets are strongly activated and this causes blood clots. The blood clots commonly affect the veins surrounding the brain, which is a very unusual and rare site for clots. Many people with VITT reported excruciating headaches, which continue to affect survivors.
Billions of platelets get used up in these clots, leading to low numbers of platelets in the blood. In some patients, this led to serious bleeding and nearly one in four died. Many survivors are also have life-long, disabling symptoms.
There are some theories about why clots in the brain happen more in patients with VITT. These include the speed of blood flow, and the stickiness of PF4 and antibodies to the blood vessels. Canadian scientists showed that patients whose antibodies stick to PF4 the strongest are most likely to get clots in the brain.
Their findings were published in the international journal Science Advances which confirmed PF4 can bind to adenoviruses. Both the AstraZeneca and Johnson & Johnson vaccines use an adenovirus to carry spike proteins from the coronavirus into people to trigger a protective immune response.
When both vaccines showed the ultra-rare side effect of VITT, scientists wondered whether the viral vector had some part to play. Another important clue was that neither the Moderna nor Pfizer vaccines, made from an entirely different technology called mRNA vaccines, showed this effect.
The team used a technology called CryoEM to flash-freeze preparations of ChAdOx1, the adenovirus used in the AstraZeneca vaccine and bombard them with electrons to produce microscopic images of the vaccine components. In particular, the team detailed the structure and receptor of ChAdOx1, which is adapted from chimpanzee adenovirus Y25 – and how it interacts with PF4. They found that ChAdOx1 has a strong negative charge. This means the viral vector can act like a magnet and attract proteins with the opposite, positive charge, like PF4.
Although adenoviral vaccines have saved millions of lives, they have fallen out of favour in developed countries because of the risk of VITT. However, these vaccines are still widely used in low-income countries.
Conclusion
So in this article, we took a look how the COVID vaccine which had serious side effects starting from the trial was inserted in us and now after two years when the grieving families went to court the companies are now accepting the adverse events.
We all are also aware of the fact that the adverse event reporting was not appropriate and thus large number of cases went unnoticed. Even after that if we see AEFI data it has been reported from the starting that Covishield had caused clot problems. The first case of neurological problem came in 2021 when clinical trials were started.
So, what we can do next is to check our body for clots by a recognized doctor and sue these companies if any serious events have been faced by anyone. Because people are now approaching courts for compensation and if one needs support then the government and vaccine companies can be made liable for the same.
This is not the first or last article about COVID-19 vaccines, we have more information that can benefit general public so keep reading Biotech Express and stay updated for biotech news.
