Covaxin from Bharat Biotech (Source/Wikipedia)
Nearly a third of those who received Bharat Biotech’s anti-Covid vaccine Covaxin reported ‘adverse events of special concern’ or AESI, according to a year-long follow-up study conducted by a team of researchers from BHU.
Nearly 50 percent of the 926 study participants complained of infections during the follow-up period, dominated by viral upper respiratory tract infections.
Severe AESI, including stroke and Guillain-Barre syndrome, was reported in one percent of individuals, claimed the study, which looked at the long-term safety of the BBV152 vaccine in adolescents and adults.
The study, published in the journal Springer Nature, comes in the wake of British pharmaceutical giant AstraZeneca admitting in a British court that its Covid vaccine can cause rare side effects such as blood clotting and lowering platelet counts.
“Almost a third of individuals developed AESIs. New-onset skin and subcutaneous tissue disorders, general disorders and nervous system disorders were the three most common disorders observed in adolescents after administration of the vaccine,” said the study, conducted from January 2022 to August. 2023, said.
The study involved 635 adolescents and 291 adults who received the BBV152 vaccine. Participants were interviewed by telephone about long-term side effects that were of particular concern after 1 year of vaccination.
New-onset skin and subcutaneous tissue disorders (10.5 percent), general disorders (10.2 percent), and nervous system disorders (4.7 percent) were the most common AESIs in adolescents.
General disorders (8.9), musculoskeletal disorders (5.8 percent) and nervous system disorders (5.5 percent) were the most common AESIs in adults.
Menstrual abnormalities were noted in 4.6 percent of female participants. Eye abnormalities and hypothyroidism were observed in 2.7 percent and 0.6 percent of participants
Four deaths (three female individuals, one male individual) were reported in adults, the study added.
All four had diabetes, while three had hypertension and two of them had a history of pre-vaccination COVID-19.
Stroke was the leading cause of two deaths and one fatality was due to post-COVID-19 rhinocerebral mucormycosis, which was suspected to have spread after vaccination, as reported by the healthcare providers.
The fourth death occurred in a woman with multiple episodes of unconsciousness after vaccination, the etiology of which remained unidentified until death. In the absence of a clear causal link, no conclusions can be drawn from these events.
Because the majority of AESIs persist for a significant period of time, expanded surveillance of COVID-19 vaccinated individuals is warranted to understand the course and outcomes of late-onset AESIs, the study underscored.
Severe AESIs may not be uncommon and require greater awareness and studies to understand the incidence of immune-mediated events following COVID-19 vaccination.
Female individuals, adolescents with COVID-19 before vaccination, those with comorbidities, and those with typhoid after vaccination had 1.6, 2, 2.7, and 3.2 times higher odds of persistent AESIs, respectively.
Adults with comorbidities had more than two times higher odds of AESIs and persistent AESIs, the study said.
Adults who received three doses and those who received one dose of BBV152 had a four- and two-fold higher risk of AESIs, respectively, compared with adults who received two doses of Covaxin, the study said.
(Only the headline and image of this report may have been reworked by Business Standard staff; the rest of the content is automatically generated from a syndicated feed.)
First print: May 16, 2024 | 6:52 PM IST