A team of BHU researchers, in a one-year follow-up study, found that among 926 individuals who received Bharat Biotech’s anti-Covid vaccine Covaxin, nearly a third reported ‘adverse events of special interest’ or AESIs. AESI is an event that occurs in some people after vaccination and is likely to be causally related to a vaccine product. (Also read: BHU study claims 1 in 3 people who took Covaxin reported adverse events)
According to the study, serious AESIs, including stroke and Guillain-Barré syndrome, were reported in approximately one percent of individuals. New-onset skin and subcutaneous disorders, general disorders and nervous system disorders were the three most common disorders seen in adolescents after receiving the vaccine. Guillain-Barré syndrome is an autoimmune disorder that causes weakness in the nerves in the arms and legs. Ischemic stroke occurs when the blood supply to part of the brain is blocked or reduced.
The study published in the journal Springer Nature looked at the long-term safety of the BBV152 (Covaxin) vaccine in adolescents and adults.
The study, conducted from January 2022 to August 2023, noted that nearly 50 per cent of the sample size complained of infections during the follow-up period, with viral upper respiratory tract infections being the predominant category.
However, Bharat Biotech said in a statement in response to the study, “Multiple studies on the safety of Covaxin have been conducted, and published in peer-reviewed journals, demonstrating an excellent safety track record.” The study included 635 adolescents and 291 adults who received the BBV152 vaccine.
Common AESIs have been reported in adults and adolescents.
- New-onset skin and subcutaneous disorders (10.5 percent), general disorders (10.2 percent), and nervous system disorders (4.7 percent) were the common AESIs in adolescents.
- General disorders (8.9), musculoskeletal disorders (5.8 percent), and nervous system disorders (5.5 percent) were the common AESIs in adults.
- Menstrual abnormalities were seen in 4.6 percent of female participants.
- Eye abnormalities and hypothyroidism were seen in 2.7 percent and 0.6 percent of participants, respectively.
Long-term side effects of Covaxin: Should people be worried?
“The manufacturing of COVID-19 vaccines, such as Bharat Biotech’s Covaxin, was essential to contain the pandemic. To guarantee patient safety and successfully address the issues, monitoring and understanding long-term adverse effects, like any therapy, was essential is important.” operation,” says Dr Vanita Arora, senior consultant cardiac electrophysiologist and interventional cardiologist at Apollo Hospitals, Delhi.
Adverse Events of Special Interest (AESI)
Research from Banaras Hindu University and other recent studies showed that about a third of the subjects experienced AESIs after a year of using Covaxin. The most frequent of these events, which varied in severity, were viral upper respiratory tract infections. More worrying were reports of serious AESIs such as stroke and Guillain-Barré syndrome.
Possible side effects of Covaxin
Dr Arora explains the possible side effects of Covaxin and whether people who have been vaccinated need to worry:
the strokes
Significant concerns are raised by stroke described as AESI, especially in patients with cardiovascular risk factors. Although the exact pathophysiological processes associated with stroke-related vaccination remain unclear, it is possible that they involve an immune-mediated process that exacerbates underlying vascular problems. Patients should be especially careful if they have a history of atrial fibrillation, diabetes, or high blood pressure. It is advisable to keep cardiovascular risk factors under control and get regular checkups done. However, it is important to consider the risk in its proper context, as the risk of serious outcomes from COVID-19 alone is still much higher than the rate of stroke after vaccination.
GBS, or Guillain-Barré syndrome
Although the incidence rate of GBS after Covaxin is minimal, it should be emphasized that its prevalence is worrying. It is important to educate patients about the early symptoms of GBS, including muscle tingling and weakness so that they can seek medical help as soon as they appear.
Impact on patients who already have health problems
“After Covaxin treatment, adults with pre-existing medical problems appear to be more susceptible to AESI. Patients suffering from long-term conditions such as diabetes, heart disease and autoimmune disorders should pay special attention. These people should maintain their daily routine should monitor their health and immediately inform their health care professional if they experience any unexpected symptoms,” says Dr. Arora.
benefits vs side effects
“While it is important to consider these adverse effects, it is also important to weigh them against the benefits of vaccination. The use of Covaxin has successfully avoided hospitalization, mortality and reduced severity of COVID-19 infection. “Significant Covid-19 outcomes, such as chronic heart problems, are often more likely to occur than significant AESIs, which have a relatively low risk,” experts say.
“Ideally a vaccine should have no side effects, but unfortunately we do not have an ideal vaccine to date. Vaccine-related adverse events usually occur rarely and get better with paracetamol and fluids. Nevertheless, the benefits of vaccination far outweigh AEIs, known as adverse events of special interest, if we analyze the impact of Covaxin in the fight against COVID. And compare them with some adverse events in some patients. So it is important not to worry about these events or lose hope,” said the head of Paras Health. Says Dr Arunesh Kumar, Consultant – Pulmonology and Respiratory Medicine.
(With inputs from PTI)
