A follow-up study by Banaras Hindu University (BHU) examining the long-term safety and side effects of Covaxin has found that 30% of the people who got jabbed with it developed adverse events of special interest (AESI). Spanning a year, the study revealed that almost 50% of the total 926 participants developed infections during this period, with those of the upper respiratory tract being predominant.
The researchers have also pointed out that serious AESI such as stroke and Guillain-Barre syndrome were observed in 1% of the participants. In addition, menstrual abnormalities were observed in 4.6% of the female participants, with 2.7% and 0.6% of the cohort experiencing ocular abnormalities and hypothyroidism, respectively. “Close to one-third of the individuals developed AESIs. New-onset skin and subcutaneous disorders, general disorders and nervous system disorders were the most common side-effects observed in adolescents after receiving the vaccine,” the researchers stated.
The study’s publication follows a recent admission by AstraZeneca that its Covishied vaccine led to a blood clotting disorder as a side effect in rare cases.
There’s no need to panic, say doctors
While the findings of the study have raised concerns among those who opted for Covaxin, doctors say there’s no need to panic.
Dr Ravindra Mehta, founder director, Vaayu, and head of department, pulmonology, Apollo Hospitals, Bangalore, says the whole pandemic has to be looked at in two stages. He adds that in the first stage, the vaccines prevented deaths and had minimal side effects — they were given emergency use authorization and cleared. “In stage 1, the vaccine was produced with an objective to prevent death during the pandemic,” he says. “But now, in stage 2, we are looking at the vaccine to prevent infections and having no side effect.”
Talking about the BHU study, Dr Mehta shares, “At present, we do not know the details of the participants or the kind of infections they were exposed to. It’s difficult to make out until you go through every aspect of the study. Initially, when COVID broke out, everyone needed a vaccine, and at that moment, the vaccine demonstrated efficacy in a small group of people, which was clear. When we are going to do the same in a larger population, there will be either the same profile (which is not common) or an expanded profile of side effects.”
At that time, considering that the risk of COVID deaths was pretty high, the focus was on ensuring survival along with minimizing severe infection and hospitalization, according to the doctor.
Dr Mehta adds that now the data will look at the long-term effects of the vaccine and the safety profiles of using different vaccines.
“This is the mature stage of looking at a medical strategy, which is probably the way pandemics work,” he says. “In the co-morbid population, we were afraid that one in five were going to die.’
What does Bharat Biotech say?
In its response to queries from Happiest Health, Bharat Biotech said: “For such a study in safety to be effective, informative and to avoid investigator bias, the following data points are also required:
- AESI safety profile of the subjects prior to participation in the study
- Comparison of the safety profile of non-vaccinated subjects during the course of the study
- Comparison of the safety profile of subjects who received other vaccines during the course of the study
- All study participants should be followed during the course of the study, instead of only a subset.”
It added, “Several studies have been executed on the safety of Covaxin, and published in peer-reviewed journals, demonstrating an excellent safety track record.”
Takeaways
A recent study conducted by researchers at Banaras Hindu University (BHU) found that those who opted for Bharat Biotech’s Covaxin developed adverse side effects, which include respiratory tract infections, menstrual abnormalities, stroke and Guillain-Barre syndrome. However, doctors urge people not to panic, stating that more extensive research is required to substantially confirm such findings.
