Over 30% of Covaxin recipients report 'adverse events' in BHU study. What are the side effects?

The participants of the study, which involved 635 adolescents and 291 adults, were interviewed telephonically about long-term adverse events of special interest a year after receiving Covaxin, which was first India-made vaccine.

Covaxin, the Covid-19 vaccine developed by Bharat Biotech, has caused several adverse side effects in recipients, including respiratory tract infections and menstrual abnormalities, a new study showed.

Published in the journal Springer Nature, the study said almost one-third of the individuals who received Bharat Biotech's Covaxin reported 'adverse events of special interest' (AESI). The analysis was a one-year follow up study conducted by a team of researchers at BHU led by Dr Sankha Shubhra Chakrabarti.

Out of 926 participants of the study, around 50 percent complained of infections during the follow-up period, which was dominated by viral upper respiratory tract infections, the research showed.

This comes just a few days after Covishield maker, UK's AstraZeneca admitted in court that the vaccine can cause rare blood clots and low blood platelet counts. The UK-based firm later withdrew the vaccine, citing abundance of newer vaccine options available.

Also read: AstraZeneca announces global withdrawal of COVID-19 vaccine amid demand crunch

Serious AESI, which included stroke and Guillain-Barre syndrome, were reported in one percent of individuals, the study, which looked at long-term safety of the BBV152 vaccine in adolescents and adults, claimed.

"Close to one third of the individuals developed AESIs. New-onset skin and subcutaneous disorders, general disorders, and nervous system disorders were the three most common disorders observed in adolescents after receiving the vaccine," the study, which was conducted between January 2022 and August 2023, said.

The participants of the study, which involved 635 adolescents and 291 adults, were interviewed telephonically about long-term adverse events of special interest a year after receiving Covaxin, which was first India-made vaccine.

Most common side effects

The most prevalent AESIs in adolescents were: New-onset skin and subcutaneous disorders (10.5 percent), general disorders (10.2 percent), and nervous system disorders (4.7 percent).

Also read: Bharat Biotech teams up with Dutch arm of Serum Institute for oral polio vaccine

In adults, general disorders (8.9 percent), musculoskeletal disorders (5.8 percent), and nervous system disorders (5.5 percent) were the common AESIs.

Finally our long term safety data of BBV152 vaccine is onlinehttps://t.co/7JtLXMl96o

— Dr Sankha Shubhra Chakrabarti (@sankha_shubhra) May 14, 2024

The study also reported four deaths in adults, which included three female individuals and one male individual). All of them had diabetes, while hypertension in three, and a history of pre-vaccination Covid-19 was present in two of them.

In the absence of a definite causality association, no conclusions can be drawn from these events.

Menstrual abnormalities

The study also noticed menstrual abnormalities in 4.6 percent of female participants. Ocular abnormalities and hypothyroidism were seen in 2.7 percent and 0.6 percent of participants.

With the majority of AESIs persisting for a significant period, extended surveillance of Covid-19-vaccinated individuals is warranted to understand the course and outcomes of late-onset AESIs, the study underlined.

Serious AESIs might not be uncommon and necessitate enhanced awareness and larger studies to understand the incidence of immunemediated phenomena post-Covid-19 vaccination.

Who is more at risk?

According to the study, female individuals, adolescents with pre-vaccination Covid-19, those with co-morbidities, and those with post-vaccination typhoid had respectively 1.6, 2, 2.7, and 3.2 times higher odds of persistent AESIs. Adults with co-morbidities had more than two times higher odds of AESIs and persistent AESIs, the study stated.

Adults receiving three doses and those receiving one dose of BBV152 were respectively at four- and two-times higher risk of AESIs compared with adults receiving two doses of the Covaxin, the study said.

With inputs from PTI