Official data indicate that the country has recorded a rise in deaths associated with side effects of the Covid vaccine, such as strokes, blood clots, and cardiac arrest. This is demonstrated by a new study from India.
The findings were published in the study by Abin Kulathunkal Rajan et al., titled “Serious adverse events following immunization and predictors of mortality associated with COVID-19 vaccination in India: a secondary data analysis of nationwide causality assessments,” which appeared in the journal Therapeutic Advances in Vaccines and Immunotherapy.
The study examines serious adverse events following immunization (AEFI) related to Covid vaccines in India. The researchers analyzed official government data, which provided information on mortality rates, injuries, disabilities, and the vaccination status of the population.
Interestingly, India is one of the few countries that did not introduce mRNA vaccines during its mass immunization campaign. Indian authorities denied approval to pharmaceutical giants Pfizer and Moderna, as reported in February 2021, so mRNA vaccines were never used there. Instead, the country relied on Covishield, an adenovirus vector vaccine from AstraZeneca, and Covaxin, an inactivated virus vaccine developed by the Indian company Bharat Biotech. During their study, the research team used reports from the National AEFI Committee of the Indian government. The study focuses on causality assessment reports published by the committee of the Indian Ministry of Health and Family Welfare.
The researchers stated that they aimed to identify trends in serious vaccine-related adverse events and determine factors that predict mortality among affected individuals.
They analyzed a total of 2,708 reported serious adverse events following immunization (AEFI). Reported AEFIs included deaths and potentially fatal reactions such as cardiac arrest and blood clots. However, long-term illnesses such as cancer, which likely led to additional deaths, were not recorded. Nevertheless, the data show rising mortality rates among those who received Covid vaccinations.
The study found that, especially among men, cardiovascular damage was closely linked to vaccine-related deaths. These findings raise some serious questions about vaccine safety monitoring in India. The study evaluates reports of serious AEFI from the start of the vaccination campaign in January 2021 through May 2023. Below are the main data sources and study parameters:
The data analyzed included 2,708 serious AEFI reports, classified by age, gender, vaccine type, seasonality, and geographic location.
- Causality assessment categories included vaccine-related reactions, immunization errors, coincidental medical events, and unclassified cases.
- Statistical methods involved logistic regression models to identify independent predictors of mortality.
- The primary endpoint was death or recovery after a serious AEFI episode.
- Covishield (the adenovirus vector vaccine from AstraZeneca/Oxford) accounted for 69.8% of AEFI cases.
- Covaxin (the inactivated virus vaccine from Bharat Biotech) was responsible for 12.8% of cases.
- The Russian vaccines Sputnik V and Corbevax had far fewer reported AEFI cases.
The study found that 1% of serious AEFI cases resulted in death. The researchers noted that this represented a significant number of fatalities. 58.9% of AEFI cases required hospitalization, but the patients recovered. According to the data, older individuals (60+) had the highest risk of vaccine-related death. Men had a significantly higher mortality rate than women.
AEFI cases whose cause was listed as “undetermined/unclassified” had a fivefold higher mortality rate than categorized AEFIs—a troubling result.
- Of the organ systems affected, the cardiovascular system was most impacted.
- Neurological and gastrointestinal complications, despite their severity, had significantly lower mortality rates.
Primarily, the high rate of “unclassified” cases is cause for great concern. A shocking 28.8% of serious AEFI cases were classified as “undetermined/unclassifiable.” However, these cases had the highest association with mortality. This unclear causality is an important warning sign and raises serious concerns about vaccine safety monitoring and diagnostic accuracy in India. If nearly a third of serious cases remain unresolved, how can health authorities effectively mitigate risks?
Another warning sign is the alarming increase in cardiovascular complications.
The dominance of cardiovascular AEFIs (31.3%)—and their significant role in mortality—is consistent with global concerns about vaccine-induced myocarditis and thrombotic events. Particularly concerning is the high percentage of unclassified AEFI cases—when causality cannot be determined to this extent, it undermines public confidence in vaccine safety monitoring.
Here is the summary from the study:
The study analyzed data from 2,708 reports of serious adverse effects reviewed by the National AEFI Committee in India up to May 2023. The study found that many serious adverse effects either occurred coincidentally (45%) or were unclassifiable (29%). Most of these reports came from individuals who had received the Covishield vaccine (70%), while fewer reports came from those who received Covaxin (13%). Of the reported serious adverse effects, 42% resulted in death, while 59% led to hospitalization but recovery. The most common adverse effects involved the heart (31%), followed by the respiratory system (13%) and the nervous system (13%). Age and gender were important factors, with older adults and men at higher risk for serious outcomes. The study also found that women, younger people, and those with certain types of adverse effects had a lower risk of death. In addition, serious adverse effects reported in North and West India and during winter showed different patterns than in other regions and times. Overall, the study shows that higher age, male gender, unclassified adverse effects, and those affecting the cardiovascular system are associated with higher mortality rates. It emphasizes the need for careful monitoring of individuals who experience serious adverse effects after vaccination, especially those at increased risk.
In the future, Indian vaccination authorities must improve transparency, strengthen real-time safety assessments, and adapt vaccination policies to protect the most vulnerable individuals.
However, it is important to note that multiple large-scale studies and official statements from Indian health authorities and the Indian Council of Medical Research (ICMR) have found no evidence that Covid-19 vaccination increases the risk of unexplained sudden death among young adults in India. In fact, these studies indicate that vaccination reduced the odds of unexplained sudden death, while factors such as prior Covid-19 hospitalization, family history of sudden death, binge drinking, drug use, and vigorous physical activity shortly before death were associated with increased risk
