1 in 3 Covaxin takers reported adverse events, BHU study claims

A one-year follow-up study conducted by researchers at Banaras Hindu University (BHU) has found that nearly one-third of individuals who received Bharat Biotech’s Covaxin reported ‘adverse events of special interest’ (AESI).

The study, which included 635 adolescents and 291 adults, aimed to assess the long-term safety of the BBV152 vaccine.

The participants were interviewed telephonically about long-term adverse events of special interest after 1 year of vaccination.

Adverse Events of Special Interest:

Around 33% of participants reported AESI, with new-onset skin and subcutaneous disorders (10.5%), general disorders (10.2%), and nervous system disorders (4.7%) among common AESIs in adolescents. Common AESIs reported by adults included general disorders (8.9%), musculoskeletal disorders (5.8%), and nervous system disorders (5.5%).

Serious AESIs, such as stroke and Guillain-Barre syndrome, were reported in 1% of participants.

Nearly 50% of the 926 participants experienced infections during the follow-up period, mainly viral upper respiratory tract infections.

Menstrual abnormalities were observed in 4.6% of female participants. Ocular abnormalities and hypothyroidism were reported in 2.7% and 0.6% of participants, respectively.

Four deaths were reported among adult participants, all of whom had diabetes and three had hypertension. Two had a history of pre-vaccination Covid-19.

Stroke was the main contributor in two deaths and one fatality was due to post-COVID-19 rhinocerebral mucormycosis, which supposedly disseminated after vaccination as reported by the caregivers, according to the study. The fourth death happened in a woman with multiple episodes of unconsciousness post-vaccination, the etiology of which remained unidentified till death, reported PTI. In the absence of a definite causality association, no conclusions could be drawn from these events.

The study underlined the need for extended surveillance to understand the long-term outcomes of AESIs and called for larger studies to investigate immune-mediated phenomena following COVID-19 vaccination.

The study comes in the wake of UK pharmaceutical giant AstraZeneca admitting its Covid vaccine can cause rare side-effects of blood clotting and lowering of platelet count in UK court.

Female participants, adolescents with pre-vaccination COVID-19, those with comorbidities, and those with post-vaccination typhoid had higher odds of persistent AESIs, reported PTI. Adults with comorbidities had more than twice the risk of AESIs and persistent AESIs.

Adults receiving three doses or one dose of BBV152 had four and two times higher risk of AESIs, respectively, compared to those receiving two doses, according to the study.