NEEDLE IN OUR ARMS, COVID VACCINES FOR HARMONY OR HARM?
Shedding light on the AstraZeneca controversy vis-à-vis the “rare” side effects of the AstraZeneca vaccine ‘Covishield’
Author: Srushti Sonawane
Oftentimes, we’re reminded to “sew a stitch in time and save nine” to avoid catastrophe. The wrath of the unknown as a consequence of negligence does carry implications that might uproot the said stitch, no matter the circumspection. One such stitch that uprooted itself is the looming Covishield uproar. In the wake of a seemingly hysterical turn of events, the Oxford-AstraZeneca vaccine, Covishield, has now been gaining traction, riding a new wave of covid vaccine controversy. Finding a needle in the haystack and locating the discrepancies in the “rare” side effects of theAstraZeneca’s Covishield vaccine are treading the same journey. The devil was pulled from under the rug when AstraZeneca submitted to a British court, wherein it conceded that Covishield might lead to rare side effects and, in very rare cases, cause Thrombosis with Thrombocytopenia Syndrome (TTS), which translates to the formation of blood clots coupled with a reduced blood platelet count. Presently, the pharma tycoon finds itself enmeshed in a legal battle, facing a substantial lawsuit exceeding £100 million (equivalent to slightly over Rs 1,000 crore).
The sheer confidence that Covishield manufacturer Company AstraZeneca has instilled amongst people made Covishield the Trojan horse amongst vaccinations. Ashray Foundation has ardently been the flagbearer of accessible healthcare to one and all, hence cautioning with some twice-wary, once-burned insight. Quoting Leonard Cohen, “There is a war between the rich and the poor, a war between the man and the woman; there is a war between those who say there is a war and those who say there isn’t.” This is a call to end this ongoing war.
Where it all began- Production of covid Covaxin and Covishield vaccine
With a dire need for a plausible and possibly permanent solution to curb the wrath of the COVID-19 pandemic, two vaccines came to humanity’s aid. Covaxin and Covishield were the warriors in disguise to combat the immediate ramifications of this bio-behemoth. Both vaccines underwent three-phased trials before making it available to the public use adhering to every medical standard. Covaxin, a product of Bharat Biotech in collaboration with the Indian Council of Medical Research and the National Institute of Virology (NIV), entered Phase 1 trials in July 2020. Despite incomplete Phase 3 trials, it received emergency use authorization in India in January 2021, starting a debate. On the other hand, Covishield, manufactured by AstraZeneca and the University of Oxford and produced by the Serum Institute of India, commenced Phase 1/2 trials in April 2020 and progressed to Phase 3 trials across multiple countries, including the UK, Brazil, South Africa, and India, by late 2020. Despite utilizing different development technologies, both vaccines were designed to acquaint the human immune system with a component of the virus, effectively preparing it to combat the actual virus if encountered in the future.
The first rumbling heralding the storm
With the unscrupulous practices actively transpiring in the background, it was apparent that the oil would rise to the surface sooner or later. Jamie Scott, hailing from the UK, was one of the first victims to blow the whistle. A parent of two, the plaintiff suffered a permanent brain injury after developing a blood clot and a cerebral haemorrhage, rendering him unable to work following the administration of the AstraZeneca vaccine in April 2021. The legal representatives advocating for the plaintiff pursuing litigation against the pharmaceutical company contended that the vaccine did not meet the expected safety standards to which they were rightfully entitled.
Ripple effect in homeland ‘covid vaccine controversy’ – The first case in India
In an attempt to ensure a smooth transition from the laboratory to the masses prior to the rollout of COVID-19 vaccines in India, the government issued a fact sheet in January 2021, alerting against administering Covishield to individuals with thrombocytopenia, a low platelet count condition. In March 2021, several European nations, including France, Germany, Italy, the Netherlands, Denmark, Norway, Iceland, Austria, Estonia, Bulgaria, Romania, Estonia, Lithuania, Luxembourg, and Latvia, temporarily halted the use of AstraZeneca’s vaccine following reports of blood clotting cases. The subsequent month, WHO-qualified occurrences of TTS after vaccinations with Covishield and Vaxzevria, AstraZeneca’s other trade name, stirred the safety pot.
Venugopalan Govindan, the bereaved father of Karunya, who tragically lost her life after receiving the vaccine, expressed that AstraZeneca’s admission is similar to ‘closing the barn door after the horse has bolted’ after an unfortunate loss of numerous lives. He distressingly stated, “We have filed a writ petition seeking compensation, as well as the appointment of an independent expert medical board, unaffiliated with the government, to promptly inquire into and investigate my daughter’s death, sharing the findings of the investigation with us. The manufacturer Serum Institute of India (SII), the government, and regulatory bodies all bear responsibility for my daughter’s and many others’ deaths.“
Averting the teeter on the brink, a petition was filed in the Supreme Court, seeking the establishment of an expert medical panel and calling to direct the Central Government to implement a vaccine injury compensation system providing redressal to the writhed citizens. A group of healthcare experts underlined the necessity for authorities to reassess the scientific underpinnings of all COVID-19 vaccines and scrutinize their commercialization process, advocating for the establishment of robust surveillance to safeguard public health and safety.
Jacob Puliyel’s Case- of Authority and Bodily Autonomy
In this pivotal case, the Supreme Court of India reflected on whether the vaccine infringes on the right to privacy and bodily autonomy under Article 21. The petitioner, a member of the National Technical Advisory Group on Immunization (NTAGI), advised the Government of India by filing a writ petition seeking directions to declare vaccine mandates unconstitutional and to release data for the COVID-19 vaccine trials conducted in India.
The Court upheld that bodily integrity is safeguarded under Article 21, and no individual can be coerced into vaccination. It affirmed that personal autonomy encompasses the right to refuse medical treatment and recommended institutions review vaccine requirements considering the evolving COVID-19 situation. In its judgment, the Supreme Court held:
“Persons who are keen to not be vaccinated on account of personal beliefs or preferences can avoid vaccination without anyone physically compelling them to be vaccinated. However, if there is a likelihood of such individuals spreading the infection to other people or contributing to mutations of the virus, thereby affecting communitarian health at large, the protection of which is undoubtedly a legitimate state aim of paramount significance in this collective battle against the pandemic, the government can regulate such public health concerns by imposing certain limitations on individual rights that are reasonable and proportionate to the object sought to be fulfilled.”
Adverse Events Following Immunization Report observations and guidelines
Adverse Events Following Immunization (AEFI) refers to any untoward medical occurrence following immunization and the appropriate use of a vaccine. On January 16, 2021, V.K. Paul, a NITI Aayog member (Health), dismissed concerns about adverse effects as unsubstantiated and insignificant, emphasizing the safety of both Covishield and Covaxin vaccines. However, this narrative took a stark turn when, on March 29, 2021, the National AEFI Committee reported a staggering 617 serious AEFIs from across the country.
Published in February 2023, a study titled ‘Serious adverse event following immunization and thromboembolic events associated with COVID-19 vaccination: An analysis of nationwide causality assessment from India’ assessed the majority of serious AEFIs for the study and found that the cases were either coincidental (578 cases; 52%) or vaccine product-related (218 cases; 19.6%). India had reported a whopping 49,819 adverse events as of November 30, 2021, including 1,965 serious cases, underscoring its gravity amidst the nation’s immunization drive. The study incorporated reports until March 2022 and causality assessments of 1,112 serious AEFIs, alarming citizens that the war is still ongoing.
N.K. Arora, who has been a part of the National Technical Advisory Group on Immunisation (NTAGI), stated that “After 2022–23, the demand for the COVID vaccine dropped, and now less than a lakh people are coming in for vaccination or the booster dose. In India, all vaccine-related AEFI are routinely monitored, and COVID is no exception.”
The devil and the deep blue sea— Bharat Biotech’s defence of safety
Cleaning their slates and making them spotless, Hyderabad-based Bharat Biotech moved swiftly, allaying concerns over its household production of Covaxin. The company unequivocally stressed Covaxin’s prototypical safety record, claiming to be devoid of any vaccine incidents involving blood clots, thrombocytopenia, or myocarditis, owing to its single-minded focus on safety. As the only COVID-19 vaccine in India’s immunization program to conduct domestic efficacy trials on over 27,000 subjects, Covaxin underwent rigorous safety reporting.
In their defence, Bharat Biotech said, “The vaccine is developed using whole-virion inactivated Vero cell-derived platform technology. Inactivated vaccines do not replicate and are therefore unlikely to revert and cause pathological effects containing dead viruses, but they still mount a defensive reaction against an infection. As product developers, the Bharat Biotech team was well aware that, while the efficacy of COVID-19 vaccines may be short-lived, the impact on patient safety could last a lifetime.” On the horns of a dilemma, Bharat Biotech inclined more towards theiragency than the safety at risk, claiming to be lesser of the two evils.
Ending the Russian roulette – Withdrawal of Covishield by AstraZeneca for commercial reasons
Casting a shadow of peril in the south, AstraZeneca has initiated a global withdrawal of its COVID-19 vaccine, Vaxzevria, citing a surplus of updated vaccines and potentially avoiding more mishaps they did not account for. Regardless, they claimed to be “incredibly proud” of the vaccine but also acknowledged that the decision to withdraw was driven by commercial considerations. They explained that the emergence of new coronavirus variants had shifted demand towards the more recently updated vaccines.
The company has also decided to withdraw the vaccine’s marketing authorizations in Europe ex post facto, admitting the inimical side effects of the AstraZeneca vaccine. They recently diversified their focus into other virus vaccines through several deals after experiencing a slowdown in growth due to declining COVID-19 medicine sales.
Also read: My Rights for My Right Health
Covishield- A Tale of Caution
Overlooking the perils of these side effects of Covishield vaccine, AstraZeneca has shook the hornet’s nest, leading to grave adversaries in the face of a healthy, well-rounded, and essential immunization. After withdrawing the same under the guise of surplus production, AstraZeneca has crossed the Rubicon, making very few substantial amends.
The covid vaccine controversy serves as a poignant reminder of the intricate balance between urgency and caution in global vaccination campaigns, prompting individuals to approach the decisions about Covaxin and Covishield, along with other vaccines, with heightened vigilance. Simultaneously, the rapid spread of the FLiRT variant globally has intensified the global health crisis.
The doctors in India have asserted that TTS occurrences were not entirely unforeseen, emphasizing that such events can occur even without vaccination as the world grapples with the implications of the FLiRT variant. The covid vaccine controversy stands as a cautionary tale, prompting a reassessment of vaccination strategies and highlighting the imperative of ongoing surveillance. Humming the caveat tune of Bob Dylan’s ‘Masters of War’, “A world war can be won, you want me to believe, but I see through your eyes, and I see through your brain, like I see through the water that runs down my drain…..”Ashray Foundation extends this once-bitten, twice-shy insight in the wake of a new storm brewing as we all navigate through this turbulent territory of the vaccine wars. Be vigilant, get vaccinated, and also beware.