Nearly 30 percent of people who took Bharat Biotech’s COVID-19 vaccine – Covaxin – experienced ‘adverse events of special interest’ (AESI), such as stroke and weakness in the nerves of their arms and legs (also called the Guillain-Barre syndrome).
This is what a year-long follow up study by researchers at the Banaras Hindu University found.
The study said,
“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.”
This comes days after Oxford-AstraZeneca came in the headlines again after the company said in a UK court that their vaccine could lead to rare adverse side effects such as thrombosis.
Key Findings of the Study
The study which was conducted between January 2022 and August 2023 involved a follow-up of 926 participants who had received the Covaxin COVID-19 vaccine.
Nearly 50 percent participants experienced respiratory infections.
10.2 percent of participants had general disorders.
10.5 percent of participants had some type of skin and subcutaneous disorder.
5.8 percent of participants developed Musculoskeletal disorders.
5.2 percent of participants developed nervous system disorders.
Over four percent women who participated in the study experienced menstrual abnormalities.
The study also reported that four adults died post taking the vaccine, but added that all four of them either had comorbidities like diabetes or hypertension, or had contracted COVID-19 before taking the vaccine shot.
“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.”BHU study on Covaxin
Did Bharat Biotech issue any clarifications? According to media reports, the company said, "Several studies have been executed on the safety of Covaxin, and published in peer-reviewed journals, demonstrating an excellent safety track record.”
Controversies surrounded the vaccine previously too: However, despite reassurances by the company, questions have surrounded Covaxin since the very first phase of clinical trials.
At the peak of the COVID-19 pandemic, experts had raised concerns about incomplete data and a lack of transparency in Covaxin manufacturing.
In March 2021, The Lancet had published the phase two clinical trial results that said that the vaccine was “safe, immunogenic, with no serious side effects.”
Around the same time Dr YK Gupta, President of AIIMS Bhopal and Jammu, and former Dean at AIIMS Delhi has said that no death or major side effects had been reported due to Covaxin.
In 2021, the Health Ministry too had said that following immunisation with Covaxin, mild side effects could occur, which could include:
Headache
Fatigue
Fever
Body ache
Abdominal pain
Nausea and vomitting
Dizziness
Tremors
Sweating
Cold and cough
However, during the phase one trial in August 2020, a patient with no prior history of comorbidities contracted viral pneumonitis after immunisation, which was not revealed to the public, but the company had maintained that an investigation was done by CDSCO and DCGI.
How does Covaxin work? Covaxin is a whole microbe inactive vaccine. It uses the killed version of the pathogen that causes the disease, like in the case of many traditional vaccines.
The SARS-CoV-2 strain for Covaxin was isolated in NIV, Pune, and transferred to Bharat Biotech.
The inactivated vaccine was then developed and manufactured in their High Containment facility in Hyderabad.
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