Highlights

  • ICMR slams BHU study on covaxin
  • Body criticises claims of covaxin's AESI
  • Study claimed Covaxin takers suffered sife-effects

Latest news

Putin ready to meet Trump 'anytime' to talk Ukraine deal

Putin ready to meet Trump 'anytime' to talk Ukraine deal

India to play Champions Trophy matches at neutral venue: ICC

India to play Champions Trophy matches at neutral venue: ICC

India's electric vehicle market to reach Rs 20 lakh crore by 2030, says Nitin Gadkari

India's electric vehicle market to reach Rs 20 lakh crore by 2030, says Nitin Gadkari

BJP MPs admitted in RML Hospital ICU with head injuries after scuffle with opposition

BJP MPs admitted in RML Hospital ICU with head injuries after scuffle with opposition

Ravichandran Ashwin's fun time with support staff reminisced by BCCI | Watch

Ravichandran Ashwin's fun time with support staff reminisced by BCCI | Watch

Mallya Calls for Justice Over Excess Debt Recovery and Legal Inconsistencies

Mallya Calls for Justice Over Excess Debt Recovery and Legal Inconsistencies

UK PM Keir Starmer hosts Indian business chiefs to boost investments

UK PM Keir Starmer hosts Indian business chiefs to boost investments

Parliament Protest Melee: Congress claims Kharge pushed, Rahul manhandled

Parliament Protest Melee: Congress claims Kharge pushed, Rahul manhandled

ICMR disassociates itself from BHU study on Covaxin side effects

The DG of the top medical body on May 20 said the study had no control arm of unvaccinated individuals for comparing the rates of events between the vaccinated and unvaccinated groups.

ICMR disassociates itself from BHU study on Covaxin side effects

The Indian Council of Medical Research Director General Dr Rajiv Bahl on Monday criticised a recently published study on the long-term safety analysis of the Covaxin in adults and adolescents for its poor methodology and design, and clarified the article misleadingly and erroneously "acknowledges" ICMR.

Dr Bahl said the study had no control arm of unvaccinated individuals for comparing the rates of events between the vaccinated and unvaccinated groups. Hence, the reported events in the study cannot be linked or attributed to COVID-19 vaccination.

The ICMR is not associated with the study and has not provided any financial or technical support for the research, Dr Bahl said.

The ICMR DG has written a letter to the authors of the paper and Editor of the journal to immediately remove the acknowledgement to ICMR and publish an erratum.

A research paper, titled 'Long-Term Safety Analysis of the BBVl52 Coronavirus Vaccine in Adolescents and Adults: Findings from a l-Year Prospective Study in North India' stated that nearly one-third of the 926 participants in the study who received Bharat Biotech's anti-Covid vaccine Covaxin reported 'adverse events of special interest,' or AESI.

Dr Bahl said that ICMR was acknowledged for research support without any prior approval of or intimation to ICMR, which is inappropriate and unacceptable. He stated that ICMR cannot be associated with this poorly designed study which purports to present a "safety analysis" of Covaxin due to several critical flaws.

He said the study does not even provide background rates of observed events in the population, making it impossible to assess the change in incidence of observed events in the post-vaccination period. Baseline information of study participants is missing.

The study tool used is inconsistent with 'Adverse Events of Special Interest (AESI)' as defined in the reference provided in the paper for AESI.

The method of data collection has a high risk of bias, he said.

Study participants were contacted telephonically one year after vaccination and their responses were recorded without any confirmation with clinical records or by physician examination, he pointed out.

Dr Bahl also noted that similar acknowledgements to ICMR have been made in previous papers without permission, raising concerns about the authors' practices.

"The authors have been urged to immediately rectify the acknowledgment to ICMR and publish an erratum. Additionally, they are asked to address the methodological concerns raised. Failure to do so may prompt ICMR to consider legal and administrative action," he said.

The Editor has been asked to retract the paper which implicitly makes conclusions on vaccine safety which are not supported by evidence.

The study, conducted by researchers from the Banaras Hindu University from January 2022 to August 2023, stated that nearly 50 per cent of 926 study participants in the study complained of infections during the follow-up period, predominated by viral upper respiratory tract infections.

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

The study involved 635 adolescents and 291 adults, who received the BBV152 vaccine.

Also watch: Risk of clotting due to Covid perhaps 100 times more than vaccine: Soumya Swaminathan

ADVERTISEMENT

Up Next

ICMR disassociates itself from BHU study on Covaxin side effects

ICMR disassociates itself from BHU study on Covaxin side effects

Parliament Protest Melee: Congress claims Kharge pushed, Rahul manhandled

Parliament Protest Melee: Congress claims Kharge pushed, Rahul manhandled

Mumbai boat tragedy: Ferry ‘Neel Kamal’ was packed beyond capacity, say police

Mumbai boat tragedy: Ferry ‘Neel Kamal’ was packed beyond capacity, say police

Indian Educationist Arun Kapur honoured with Bhutan’s prestigious royal honour ‘Dasho’

Indian Educationist Arun Kapur honoured with Bhutan’s prestigious royal honour ‘Dasho’

Uttar Pradesh: Six killed in Shahjahanpur road accident

Uttar Pradesh: Six killed in Shahjahanpur road accident

Arvind Kejriwal urges NDA allies to reconsider support for BJP over Amit Shah’s Ambedkar remark

Arvind Kejriwal urges NDA allies to reconsider support for BJP over Amit Shah’s Ambedkar remark

ADVERTISEMENT

editorji-whatsApp

More videos

Andhra High Court upholds lesbian couple’s right to live together, parents told not to ‘interfere’

Andhra High Court upholds lesbian couple’s right to live together, parents told not to ‘interfere’

FIR against Samajwadi Party’s Sambhal MP for power theft

FIR against Samajwadi Party’s Sambhal MP for power theft

Mumbai boat tragedy: Life jackets made mandatory for rides from Gateway of India

Mumbai boat tragedy: Life jackets made mandatory for rides from Gateway of India

Eknath Shinde pays tribute to RSS founder, highlights Sangh's nation-building role

Eknath Shinde pays tribute to RSS founder, highlights Sangh's nation-building role

Delhi to Promote Linguistic Diversity with Multilingual Road Signages and Bureaucratic Nameplates

Delhi to Promote Linguistic Diversity with Multilingual Road Signages and Bureaucratic Nameplates

NDA and INDIA bloc MPs clash in Parliament; BJP accuses Rahul Gandhi of pushing its MP

NDA and INDIA bloc MPs clash in Parliament; BJP accuses Rahul Gandhi of pushing its MP

Punjab govt releases Rs 28 crore for pregnant women, lactating mothers under Matru Vandana Yojana

Punjab govt releases Rs 28 crore for pregnant women, lactating mothers under Matru Vandana Yojana

Punjab: Over 200 accident victims receive treatment under Farishtey scheme

Punjab: Over 200 accident victims receive treatment under Farishtey scheme

NDA, INDIA bloc MPs hold protest marches in parliament premises over Ambedkar issue

NDA, INDIA bloc MPs hold protest marches in parliament premises over Ambedkar issue

Jalandhar police returns seized property worth Rs 13 crores to rightful owners

Jalandhar police returns seized property worth Rs 13 crores to rightful owners

Editorji Technologies Pvt. Ltd. © 2022 All Rights Reserved.