(Image source from: Thehindu.com)

A study conducted by Upinder Kaur and her team of 11 researchers from Banaras Hindu University has revealed that almost half of the adolescents who received Bharat Biotech's Covaxin vaccine reported infections, primarily upper respiratory tract infections, within a year of receiving the vaccine. The study also found that the three most common disorders among adolescents were skin and subcutaneous disorders, nervous system disorders, and general disorders. While most disorders had resolved by the final follow-up after six months, skin conditions persisted in the majority of cases even after eight and a half months. The study investigated the long-term safety of Covaxin after one year and was based on data received from 577 adolescents and 225 adults. Alopecia and general disorders such as weakness were reported by one in ten adolescents who received Covaxin. Furthermore, nervous system disorders were experienced by almost 5% of both adolescents and adults, and eye disorders were reported among 3% of those vaccinated.

Around 1 in 10 adolescent females reported experiencing menstrual abnormalities, while hypothyroidism was reported by approximately 0.6% of both adolescents and adults. Gastrointestinal disturbances were common among adults, according to the study. Among adolescents, those with a history of allergies, pre-vaccination Covid-19, and post-vaccination typhoid had a higher incidence of adverse events. The study found that four adults with a history of diabetes and hypertension died from Covid-19 before vaccination, with causes of death including stroke, post-Covid-19 fungal infection, and an unidentified disease following multiple episodes of unconsciousness. The study also noted that vaccinated adolescents who developed typhoid after receiving Covaxin were at higher risk of adverse events of special interest. Similarly, adolescent females and those with comorbidities were at higher risk of persistent adverse events. The study highlighted that adults with comorbidities, especially hypertension, were at higher risk of adverse events after receiving Covaxin. The researchers recommended extended surveillance of those who received Covid vaccines to better understand late-onset adverse events and their outcomes.

Since the study was mainly carried out on individuals from the northern region of India, the researchers suggested investigating variances in vaccine tolerance based on ethnicity. Bharat Biotech responded to the study by stating that numerous studies have already examined the safety of Covaxin and have been published in reputable journals, proving its exceptional safety record. Bharat Biotech said such safety studies are intended to be effective and meaningful before study participation and to avoid researcher bias, data on AESI safety profile of individuals is required. Likewise, a comparison of the safety profile of people who were not vaccinated during the study period and a comparison of the safety profile of people who received other vaccines during the study period is also required, the company said. He added: Not just part of it, but also during the investigation.