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The Indian Council of Medical Research Director General Dr Rajiv Bahl on Monday criticised a recently published study on the long-term safety analysis of the <keyword id="9485939" type="General" weightage="100" keywordseo="covaxin" source="Orion">Covaxin</keyword> in adults and adolescents for its poor methodology and design, and clarified the article misleadingly and erroneously "acknowledges" <keyword id="19918794" type="General" weightage="20" keywordseo="ICMR" source="keywords">ICMR</keyword>. Dr Bahl said the study had no control arm of unvaccinated individuals for comparing the rates of events between the vaccinated and unvaccinated groups. Hence, the reported events in the study cannot be linked or attributed to COVID-19 vaccination. He added that the ICMR is not associated with the study and has not provided any financial or technical support for the research. The ICMR DG has written a letter to the authors of the paper and Editor of the journal to immediately remove the acknowledgement to ICMR and publish an erratum. A research paper, titled 'Long-Term Safety Analysis of the BBVl52 <keyword id="21730391" type="General" weightage="20" keywordseo="coronavirus-vaccine" source="keywords">Coronavirus Vaccine</keyword> in Adolescents and Adults: Findings from a l-Year Prospective Study in North India' stated that nearly one-third of the 926 participants in the study who received Bharat Biotech's anti-Covid vaccine Covaxin reported 'adverse events of special interest,' or AESI. Dr Bahl said that ICMR was acknowledged for research support without any prior approval of or intimation to ICMR, which is inappropriate and unacceptable. He stated that ICMR cannot be associated with this poorly designed study which purports to present a "safety analysis" of Covaxin due to several critical flaws. He said the study does not even provide background rates of observed events in the population, making it impossible to assess the change in incidence of observed events in the post-vaccination period. Baseline information of study participants is missing. The study tool used is inconsistent with 'Adverse Events of Special Interest (AESI)' as defined in the reference provided in the paper for AESI. The method of data collection has a high risk of bias, he said. Study participants were contacted telephonically one year after vaccination and their responses were recorded without any confirmation with clinical records or by physician examination, he pointed out. Dr Bahl also noted that similar acknowledgements to ICMR have been made in previous papers without permission, raising concerns about the authors' practices. "The authors have been urged to immediately rectify the acknowledgment to ICMR and publish an erratum. Additionally, they are asked to address the methodological concerns raised. Failure to do so may prompt ICMR to consider legal and administrative action," he said. The Editor has been asked to retract the paper which implicitly makes conclusions on <keyword id="21495684" type="General" weightage="20" keywordseo="vaccine-safety" source="keywords">vaccine safety</keyword> which are not supported by evidence. The study, conducted by researchers from the Banaras Hindu University from January 2022 to August 2023, stated that nearly 50 per cent of 926 study participants in the study complained of infections during the follow-up period, predominated by viral upper respiratory tract infections. Serious AESI, which included stroke and Guillain-Barre syndrome, were reported in one per cent of individuals, the study, which looked at long-term safety of the BBV152 (Covaxin) vaccine in adolescents and adults, claimed. The study involved 635 adolescents and 291 adults, who received the BBV152 vaccine.

BHU study on Covaxin side effects poorly designed, critically flawed: ICMR Director General

Ever since the virus reared its ugly head and briefly sent the world into despair, the coronavirus has remained a staple, albeit almost sidelined, part of the news cycle. Despite this, the topic has come to the forefront of controversy once again, with an extremely popular <keyword id="20040659" type="General" weightage="20" keywordseo="COVID-19-vaccine" source="keywords">COVID-19 vaccine</keyword> now under scrutiny. Considering that the world is still healing from the scars left behind by the coronavirus tragedy, it is imperative that we gauge the situation to avoid any unwarranted public paranoia. Let’s look at the facts behind the ongoing <keyword id="19910149" type="General" weightage="20" keywordseo="AstraZeneca" source="keywords" meta.keywordsubtype="org" meta.entityname="AstraZeneca" meta.hostid="261" meta.entityid="AstraZeneca">AstraZeneca</keyword> (or <keyword id="19960109" type="General" weightage="100" keywordseo="covishield" source="keywords">Covishield</keyword>, as it is known in India) vaccine controversy, and determine if there really is a cause for worry. <cmsannotation type="cmsannotation" annotationid="What happened?" comment="subhead" text="What happened?">What happened?</cmsannotation> Shortly after receiving the AstraZeneca COVID-19 vaccine in 2021, UK-based <keyword id="21472612" type="General" weightage="20" keywordseo="jamie-scott" source="keywords">Jamie Scott</keyword> experienced a harrowing ordeal. He developed a brain clot and severe bleeding, resulting in permanent brain injury. This condition, known as <keyword id="21475609" type="General" weightage="20" keywordseo="Thrombosis-with-Thrombocytopenia-Syndrome" source="keywords">Thrombosis with Thrombocytopenia Syndrome</keyword> (<keyword id="20218859" type="General" weightage="20" keywordseo="tts" source="keywords">TTS</keyword>), can lead to dangerously low blood clot and platelet levels, posing a grave risk to those affected. Jamie's struggles with memory loss, impaired vision, and diminished cognitive abilities compelled him to seek legal recourse against the pharmaceutical company in 2023. Jamie's legal representative contends that AstraZeneca minimized the potential risks linked to their vaccines. Moreover, reports indicate that over 50 vaccinated individuals experienced similar adverse conditions, with numerous cases resulting in fatalities or severe injuries. Despite these assertions, the pharmaceutical company refutes the allegations, stating that they do not acknowledge a causal relationship between the vaccine and Thrombosis with Thrombocytopenia Syndrome (TTS) on a generic level. However, a year of court wrangling later, legal documents submitted by AstraZeneca have now admitted that their vaccine can cause TTS in very rare cases, although the causal mechanism is still not well known. This revelation has led to renewed uproar against the vaccine’s side-effects. <cmsannotation type="cmsannotation" annotationid="Is there cause for worry?" comment="subhead" text="Is there cause for worry?">Is there cause for worry?</cmsannotation> In short words, not really. Links between the <keyword id="21483117" type="General" weightage="20" keywordseo="AstraZeneca-vaccine" source="keywords">AstraZeneca vaccine</keyword> and vaccine-induced immune TTS have been scientifically identified since early 2021, soon after the first COVID-19 vaccines had come out. However, it is so very rare — a few dozen reported cases among the millions administered — that even the World Health Organisation has deemed the vaccine “safe and effective” for all individuals aged 18 and above. Moreover, even influenza, H1N1 and rabies vaccines can cause TTS in very rare instances. Further, it is important to note that an infection with COVID-19 is itself a major cause for clot, heart attacks and strokes. Being vaccinated actually lowers these risks. There is also the fact that all vaccines or drugs carry potential side-effects, and these medical interventions are only cleared for release after determining that their benefits vastly outweigh any complications. Finally, the <keyword id="21483118" type="General" weightage="20" keywordseo="TTS-side-effects" source="keywords">TTS side-effects</keyword> — which include symptoms such as headaches, blurred vision, chest pain, leg swelling or tiny blood spots under the skin — manifest between 1-6 weeks of vaccination. Considering that most Indians received their Covishield jab a couple of years ago, there should be no reason to panic now. <cmsannotation type="cmsannotation" annotationid="Is it time to consider alternate vaccines?" comment="subhead" text="Is it time to consider alternate vaccines?">Is it time to consider alternate vaccines?</cmsannotation> There is no particular hard evidence that suggests the supremacy of one vaccine over another, considering that they all carry varying degrees of side-effects. That being said, <keyword id="9485939" type="General" weightage="20" keywordseo="covaxin" source="Orion">Covaxin</keyword> boasts a higher efficacy than Covishield, and has better research data among Indian subjects. However, it may also be important to know that the administration of the AstraZeneca vaccine has been discontinued in many countries, mainly due the aforementioned risk of blood clotting in certain age groups. Whatever the choice, the fact of the matter remains that these vaccines have saved millions since their introduction, and it is pertinent that we continue taking them diligently, unless any premier health authorities recommend otherwise.

Should you be worried about the potential side-effects of the Covishield vaccine?

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BHU study on Covaxin side effects poorly designed, critically flawed: ICMR Director General

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