A study conducted by researchers at Banaras Hindu University (BHU) says a third of the surveyed individuals who received Bharat Biotech’s Covid-19 vaccine Covaxin reported adverse events of special interest (AESI) after a one-year follow-up.
The study was conducted from January 2022 to August 2023 involving 635 adolescents and 291 adults, who received the BBV152 (Covaxin) vaccine.
As quoted by Business Standard, this new study from BHU published in the journal Springer Nature says that “Close to one-third of the individuals developed AESIs. New-onset skin and subcutaneous disorders, general disorders, and nervous system disorders were the three most common disorders observed in adolescents after receiving the vaccine.”
The study comes says after UK drugmaker AstraZeneca admitted in a court that its Covid vaccine, sold as Covishield in India, can cause rare side-effects of blood clotting and lowering of platelet count in a UK court.
After Covishield, the study on Covaxin has raised concern among people. However, doctors and health experts maintain that there is no need to panic.
The Hyderabad-based company pointed out lapses in the research. According to a statement reported in the Financial Express Health Care, the Covaxin maker said that for a study to be effective, informative and to avoid investigator bias, a few data points are required, including the AESI safety profile of the subjects before the participation in the study.
According to Bharat Biotech, a comparison of the safety profile of non-vaccinated subjects during the study, a comparison of the safety profile of subjects who received other vaccines during the study, and all study participants should be followed during the study, instead of only a subset.
“Several studies have been executed on the safety of Covaxin, and published in peer-reviewed journals, demonstrating an excellent safety track record,” the company said.
The details of the study as reported by Business Standard claim that the new-onset skin and subcutaneous disorders (10.5 percent), general disorders (10.2 percent), musculoskeletal disorders (5.8 percent), and nervous system disorders (5.5 percent) were the common AESIs in adults. Menstrual abnormalities were noticed in 4.6 percent of female participants. Ocular abnormalities and hypothyroidism were observed in 2.7 percent and 0.6 percent of participants. Four deaths (three female individuals, and one male individual) were reported in adults, the study added.
All four had diabetes, hypertension in three, and a history of pre-vaccination Covid-19 was present in two of them. The fourth death happened in a woman with multiple episodes of unconsciousness post-vaccination, the etiology of which remained unidentified until death.
