BREAKING! Peer Reviewed Study Shows That One Third Of Covaxin Recipients In India Plagued By Adverse Effects Even One Year Later!

COVID-19 News: A recent peer-reviewed study published in the academic journal Drug Safety by Springer International has brought alarming news to light: nearly one-third of individuals who received the Covaxin (ChAdOx1-nCoV-19 COVID-19 vaccine) in India have reported adverse events of special interest (AESI) even one-year post-vaccination. This study has raised significant concerns about the long-term safety of Covaxin, a vaccine developed by Hyderabad-based Bharat Biotech, which was the second most used COVID-19 vaccine in India after Covishield. The findings come amidst growing scrutiny of COVID-19 vaccines globally, particularly in light of admissions by pharmaceutical giants like AstraZeneca about potential rare side effects associated with their vaccines.


Peer Reviewed Study Shows That One Third Of Covaxin Recipients In
India Plagued By Adverse Effects Even One Year Later
 
Key Findings of the Study
The study conducted by researchers at the Institute of Medical Sciences,
Banaras Hindu University (BHU), Varanasi-India involved telephonic follow-ups with 926 Covaxin recipients to assess long-term adverse effects. The findings are concerning:
 
-Upper Respiratory Tract Infections
A significant number of both adolescents and adults reported viral upper respiratory tract infections. Specifically, 48% of adolescents and 43% of adults reported such infections. These infections were the most commonly reported adverse events among the study participants, raising questions about the vaccine’s impact on the respiratory system over an extended period.
 
-New-Onset Disorders
Commonly reported AESIs included new-onset skin and subcutaneous disorders, musculoskeletal disorders, and nervous system disorders. These conditions suggest a broad range of potential immune and inflammatory responses triggered by the vaccine. The prevalence of these disorders indicates that the vaccine might have systemic effects that need thorough investigation.
 
-Menstrual Abnormalities
About 5% of women who received Covaxin experienced menstrual abnormalities. This particular finding is significant as it highlights gender-specific side effects that were perhaps not adequately captured during the initial clinical trials. The menstrual abnormalities reported include changes in cycle length, flow intensity, and irregular bleeding, which could have profound implications for women’s health.
 
-Serious AESIs
Serious adverse events such as stroke and Guillain-Barre syndrome were reported in 1% of the individuals. These severe conditions, although rare, point to the need for ongoing monitoring and support for individuals who have received the vaccine. The occurrence of such serious AESIs raises important questions about the mechanisms through which the vaccine might trigger these conditions.
 
-Deaths
Four deaths were reported among adults in the sample group, all of whom had pre-existing conditions such as diabetes and hypertension. The study noted that these individuals had complex medical histories, which complicates the determination of causality. However, the association between vaccination and these deaths cannot be entirely ruled out without further detailed investigations.
 
A Comparative Analysis with Covishield
This study comes on the heels of AstraZeneca's admission in a UK court that its COVID-19 vaccine technology, used to develop Covishield by the Serum Institute of India, could cause blood clots with low platelet count, also known as thrombosis with thrombocytopenia syndrome (TTS). The revelation has prompted comparisons between the two vaccines, Covishield and Covaxin, both of which have been widely administered in India.
 
Covishield was the first COVID-19 vaccine to be rolled out in India, followed by Covaxin. While both vaccines have played critical roles in controlling the spread of COVID-19 in India, the recent findings highlight the need for continuous safety monitoring. The differences in side effect profiles between Covishield and Covaxin suggest that individual responses to these vaccines can vary significantly, necessitating a more personalized approach to vaccination.
 
Bharat Biotech's Response
Bharat Biotech has responded to the study by pointing out several lapses and emphasizing the need for comprehensive data points to avoid bias. The company highlighted that for a safety study to be informative, it is crucial to consider:
 
-Pre-Participation Health Profiles: The AESI safety profile of subjects before participation in the study must be considered to determine whether the reported adverse events were indeed new or pre-existing conditions exacerbated by the vaccine.
 
-Comparative Safety Analysis: Comparison of the safety profile of non-vaccinated subjects and those who received other vaccines during the study period is essential to provide context and understand if the adverse events are unique to Covaxin.
 
-Continuous Follow-Up: All study participants should be continuously followed throughout the study period, rather than relying on a subset of participants, to capture the full spectrum of potential adverse events.
 
Bharat Biotech has also stressed that multiple studies have demonstrated the safety of Covaxin, which has been published in peer-reviewed journals. The company insists that Covaxin remains one of the safest vaccines globally, with its safety profile established through rigorous clinical trials and real-world data.
 
Various local COVID-19 News outlets in India also carried news about the adverse effects from the Covaxin COVID-19 vaccine.
 
https://timesofindia.indiatimes.com/india/over-30-covaxin-takers-suffered-from-health-issues-after-1-year-report/articleshow/110179195.cms
 
https://indianexpress.com/article/india/covaxin-health-issues-bhu-study-9333137/
 
https://www.business-standard.com/health/study-on-covid-vaccine-covaxin-reports-adverse-events-in-some-participants-124051601530_1.html
 
https://www.hindustantimes.com/india-news/1-in-3-covaxin-takers-reported-adverse-events-bhu-study-claims-101715866580781.html
 
https://www.ndtv.com/india-news/over-30-covaxin-takers-suffered-health-issues-after-a-year-claims-bhu-study-5676716
 
https://www.tribuneindia.com/news/india/30-covaxin-takers-reported-adverse-events-621950
 
https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/now-covaxin-reveals-side-effects-what-are-the-symptoms-reported-in-adverse-affect-cases-should-you-worry/articleshow/110166462.cms
 
Detailed Insights from the BHU Study
The study, led by Sankha Shubhra Chakrabarti at Banaras Hindu University (BHU), involved 635 adolescents and 291 adults who received the BBV152 vaccine (Covaxin). The participants were interviewed about long-term AESIs one year post-vaccination. Key findings include:
 
Adolescents
New-Onset Skin and Subcutaneous Disorders: Reported by 10.5% of adolescents, these include conditions like rashes, dermatitis, and other skin irritations.
General Disorders: Experienced by 10.2% of adolescents, these include symptoms like fatigue, malaise, and fever.
 
-Nervous System Disorders: Noted in 4.7% of adolescents, these disorders encompass a range of neurological symptoms including headaches, dizziness, and neuropathy.
 
Adults
-General Disorders: Reported by 8.9% of adults, including persistent fatigue and general weakness.
 
-Musculoskeletal Disorders: Experienced by 5.8% of adults, involving conditions like joint pain, muscle aches, and arthritis.
Nervous System Disorders: Noted in 5.5% of adults, similar to those reported by adolescents.
 
Specific Conditions
-Menstrual Abnormalities: Affected 4.6% of female participants, highlighting the need for gender-specific studies and monitoring.
 
-Ocular Abnormalities: Observed in 2.7% of participants, including issues like vision changes and eye discomfort.
 
-Hypothyroidism: Noted in 0.6% of participants, pointing to potential endocrine disruptions.
 
Risks and Recommendations
The study identified specific demographics at higher risk of AESI, including female adolescents and individuals with a history of allergies. Persistent AESIs were noted in individuals with pre-vaccination COVID-19, comorbidities, and post-vaccination typhoid. The researchers have recommended extended surveillance of vaccinated individuals to understand the long-term outcomes of adverse events.
 
Focus on Safety
In response to these findings, Bharat Biotech reiterated its commitment to safety. Krishna Ella, Executive Chairman of Bharat Biotech, emphasized that safety is the top priority in vaccine development. He stated, "Covaxin is perhaps the safest vaccine in the entire world; it stays in the muscle but does not enter the body." Ella's comments underline the company's stance that the vaccine's design inherently reduces the risk of systemic side effects.
 
A Global Context
The findings from the BHU study come at a time when vaccine safety is under global scrutiny. Similar concerns have been raised about other COVID-19 vaccines, including those from AstraZeneca and Pfizer. The global effort to vaccinate billions of people quickly during the pandemic has led to unprecedented scale and speed in vaccine development, approval, and deployment. While this has been crucial in controlling the pandemic, it has also meant that long-term safety data is still emerging.
 
Importance of Continuous Monitoring
The importance of continuous monitoring and rigorous safety evaluations of COVID-19 vaccines cannot be overstated. As more data becomes available, it is essential to adapt and refine vaccination strategies to ensure public safety. The differences in adverse event patterns between Covaxin and Covishield highlight the need for ongoing research and surveillance.
 
The Road Ahead
Given the prolonged persistence of adverse events, researchers have recommended extended surveillance of COVID-19-vaccinated individuals to comprehend the course and outcomes of late-onset adverse events. The study's findings underscore the need for:
 
-Individualized Vaccination Strategies: Moving away from a one-size-fits-all approach to vaccination and considering individual health profiles and risk factors.
 
-Focused Monitoring: Particularly for individuals with a pre-vaccination history of COVID-19, underlying health conditions, and those who have experienced significant adverse events post-vaccination.
 
-Public Awareness: Educating the public about potential side effects and the importance of reporting any adverse events to health authorities.
 
Conclusion
The findings from the BHU study underscore the importance of continuous monitoring and rigorous safety evaluations of COVID-19 vaccines. While Covaxin has been a critical tool in India's fight against COVID-19, the reported adverse effects necessitate a closer examination of its long-term safety profile. The differences in adverse event patterns between Covaxin and Covishield further highlight the need for individualized vaccination strategies.
 
As the world moves forward in managing the COVID-19 pandemic, ensuring the safety and efficacy of vaccines remains paramount. This study serves as a reminder that vigilance and transparency are essential in maintaining public trust in vaccination programs. The journey towards comprehensive vaccine safety is ongoing, and studies like this play a crucial role in guiding public health policies and ensuring the well-being of vaccinated individuals.
 
The study findings can be found here:
https://link.springer.com/article/10.1007/s40264-023-01301-8
 
For the latest COVID-19 News, keep on logging to Thailand Medical News.
 
Read Also: https://twitter.com/ThailandMedicaX/status/1770413720654790724