Covaxin side-effects: A study conducted by the Banaras Hindu University (BHU) stated that nearly one-third of 926 Covaxin recipients reported ‘adverse events of special interest’ or AESI.
Meanwhile, Bharat Biotech said that the vaccine demonstrated “excellent safety track record” in several studies.
In its statement, 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 prior to the participation in the study.
According to Bharat Biotech, comparison of safety profile of non-vaccinated subjects during the course of the study, comparison of safety profile of subjects who received other vaccines during the course of the study and all study participants should be followed during the course of 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 study found that upper respiratory tract infection, new-onset skin and subcutaneous disorders, musculoskeletal and nervous system disorders, menstrual abnormalities, and hypothyroidism were prevalent among the participating recipients.
Among serious side effects stroke and Guillain-Barre Syndrome were identified in nearly one percent of the individuals, the study found.
The study was conducted from January 2022 to August 2023. This study comes 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.
Covaxin side-effects: What this means for you?
After covishield, the study on Covaxin has raised concern among the people. However, doctors and health experts maintain that there is no need to panic.
“The sample size of the study is very small. There is no need to be worried…the cases of serious adverse events are very low. I would like to clear this doubt that there is no need to be worried and concerned over this study. The research only highlights what some participants experienced and there is a need to do a large scale study to understand the impact,” Dr Ashwani Mehta, Senior Consultant, Department of Cardiology, Sir Ganga Ram Hospital said.
He also emphasised that no research has till now revealed that there is a long-term impact of the side-effects of the vaccine.
“…the side-effects are observed only within 40-45 days after vaccination. So, there is no need to be worried if you are vaccinated. If you are experienced some health issues now, its unlikely that the cause is the vaccine,” he explained.
Consult the doctors if you are facing medical issues, don’t assume that its because of a vaccine, he emphasised.
Ideally a vaccine should not have any side effect but unfortunately we don’t have an ideal vaccine to date, Dr Arunesh Kumar, Head & Senior Consultant – Pulmonology and Respiratory Medicine, Paras Health told Financial Express.com.
“Vaccine related adverse events usually happen rarely and get better with paracetamol and taking fluids. Nonetheless, the advantages of vaccination far surpass the risks by shielding us from severe health complications,” Dr. Kumar said.
AESIs, known as Adverse Events of Special Interest have been raised with certain patients who had Covaxin, he said.
“If we analyse the effect of Covaxin on fight against COVID and compare them to certain adverse event in few patients, benefits clearly outweigh risk. It’s therefore important not to fret or lose hope about these occurrences,” he added.
