A recent study conducted by researchers at the Banaras Hindu University (BHU) says that nearly 30 per cent of the 926 recipients of Bharat Biotech's Covaxin reported experiencing adverse events of special interest (AESI).

The adverse events reported by the recipients include stroke and Guillain-Barre syndrome – a disorder that causes weakness in nerves in arms and legs – found in one per cent of the participants.

Adult participants experienced various issues, including general disorders, musculoskeletal disorders, and nervous system disorders.&nbsp;

Also read:&nbsp;<a href="https://www.wionews.com/science/genetics-linked-to-rare-blood-clots-from-jj-and-astrazeneca-covid-vaccines-researchers-claim-722040">Genetics linked to rare blood clots from J&amp;J and AstraZeneca Covid vaccines, researchers claim</a>

For adolescents, the most frequent AESIs were skin and subcutaneous disorders, general disorders, and nervous system disorders. Additionally, approximately 4.6 percent of women reported menstrual abnormalities, according to the study.

The study further mentions, “Around 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."

Four deaths (three female, one male) were reported in adults, the study said, as reported by PTI. All four had diabetes, while hypertension was found in&nbsp;three, and a history of pre-vaccination COVID-19 was present in two of them, it said.

"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 added.

<h2>Bharat Biotech’s response&nbsp;</h2>

The study was conducted from January 2022 to August 2023 and&nbsp;indicated that around 50 percent of the sample size reported infections, with viral upper respiratory tract infections being the most common.

When asked Bharat Biotech to respond, it said that several studies have been executed on the safety of Covaxin, and published in peer-reviewed journals, demonstrating an excellent safety track record.

<a href="https://www.wionews.com/india-news/plea-filed-in-indias-top-court-seeking-investigation-into-covishield-side-effects-717027">Also read | Plea filed in&nbsp;India’s&nbsp;top court seeking investigation into Covid vaccine Covishield's side&nbsp;effects</a>

It also outlined several requirements for such a study, including an assessment of the AESI profile of the participants.&nbsp;

Additionally, it stated that there should be a comparison of the safety profile of non-vaccinated subjects throughout the study. The study on Covaxin comes a few days after AstraZeneca withdrew its Covid-19 vaccine, provided in India as 'Covishield', following reports of rare side-effects such as blood-clotting.

(With inputs from agencies)

A recent study conducted by researchers at the Banaras Hindu University (BHU) says that nearly 30 per cent of the 926 recipients of Bharat Biotech's Covaxin reported experiencing adverse events of special interest (AESI).

A recent study conducted by researchers at the Banaras Hindu University (BHU) says that nearly 30 per cent of the 926 recipients of Bharat Biotech's Covaxin reported experiencing adverse events of special interest (AESI). The adverse events reported by the recipients include stroke and Guillain-Barre syndrome – a disorder that causes weakness in nerves in arms and legs – found in one per cent of the participants. Adult participants experienced various issues, including general disorders, musculoskeletal disorders, and nervous system disorders. Also read: Genetics linked to rare blood clots from J&J and AstraZeneca Covid vaccines, researchers claim For adolescents, the most frequent AESIs were skin and subcutaneous disorders, general disorders, and nervous system disorders. Additionally, approximately 4.6 percent of women reported menstrual abnormalities, according to the study. The study further mentions, “Around 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." Four deaths (three female, one male) were reported in adults, the study said, as reported by PTI. All four had diabetes, while hypertension was found in three, and a history of pre-vaccination COVID-19 was present in two of them, it said. "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 added. Bharat Biotech’s response The study was conducted from January 2022 to August 2023 and indicated that around 50 percent of the sample size reported infections, with viral upper respiratory tract infections being the most common. When asked Bharat Biotech to respond, it said that several studies have been executed on the safety of Covaxin, and published in peer-reviewed journals, demonstrating an excellent safety track record. Also read | Plea filed in India’s top court seeking investigation into Covid vaccine Covishield's side effects It also outlined several requirements for such a study, including an assessment of the AESI profile of the participants. Additionally, it stated that there should be a comparison of the safety profile of non-vaccinated subjects throughout the study. The study on Covaxin comes a few days after AstraZeneca withdrew its Covid-19 vaccine, provided in India as 'Covishield', following reports of rare side-effects such as blood-clotting. (With inputs from agencies)

Over 30% of Covaxin takers experienced nervous system disorders, menstrual abnormalities, suggests study

Bharat Biotech said that it has concluded the final analysis for its COVID-19 vaccine Covaxin as part of phase-3 clinical trials. The Hyderabad-based pharma company claimed that its indigenous jab demonstrates an overall efficacy of 77.8% against symptomatic infection.

Bharat Biotech announces Covaxin's efficacy rate after final stage trials

Bharat BioTech on Wednesday claimed that its <a href="https://www.wionews.com/topics/coronavirus-vaccine">coronavirus vaccine </a>Covaxin has an efficacy of 78 per cent against mild, moderate and severe cases of Covid-19, according to the Phase 3 interim analysis results.&nbsp;

It highlighted that the second interim data of the Phase 3 study showed that the hospitalisation rate due to novel coronavirus reduced by 100 per cent after taking the Covaxin shot.&nbsp;

Watch |&nbsp;

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The recent spike in Covid-19 infections led to 127 symptomatic cases being recorded after taking the vaccine's shot, leading to an efficacy of 78 per cent against mid, moderate and severe cases, the pharma company said in a statement.&nbsp;

It added that the vaccine has an efficacy of 70 per cent in asymptomatic infection.

Also read | <a href="https://www.wionews.com/india-news/covaxin-is-effective-against-multiple-variants-of-coronavirus-indian-medical-body-378960">Covaxin is effective against multiple variants of coronavirus: Indian medical body</a>

"Efficacy against SARS-Cov-2 has been established. Covaxin has demonstrated an excellent safety record in human clinical trials and in usage under emergency use. Covaxin is now a global innovator vaccine derived from R&amp;D in India," Bharat BioTech Chairman and Managing Director Krishna Ella was quoted as saying by news agency PTI.&nbsp;

Ella also said that the protocols for manufacturing, testing and release of inactivated vaccines meet the requirements of WHO, Indian, and other regulatory authorities.&nbsp;

"These protocols have delivered consistent results over a 15-year period with more than 300 million doses supplied globally, with excellent safety and performance record," the MD said.&nbsp;

The pharma company said final analysis results will be available in June and the final report will then be sent to a peer-reviewed publication.&nbsp;

Covaxin has been jointly prepared by Bharat BioTech and ICMR.&nbsp;

Balram Bhargava, Director General of ICMR and Secretary of Department of Health Research said that Covaxin "works well against" most variants of coronavirus. &nbsp;

 
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Bharat BioTech on Wednesday claimed that its coronavirus vaccine Covaxin has an efficacy of 78 per cent against mild, moderate and severe cases of Covid-19, according to the Phase 3 interim analysis results.

Bharat BioTech on Wednesday claimed that its coronavirus vaccine Covaxin has an efficacy of 78 per cent against mild, moderate and severe cases of Covid-19, according to the Phase 3 interim analysis results. It highlighted that the second interim data of the Phase 3 study showed that the hospitalisation rate due to novel coronavirus reduced by 100 per cent after taking the Covaxin shot. Watch | The recent spike in Covid-19 infections led to 127 symptomatic cases being recorded after taking the vaccine's shot, leading to an efficacy of 78 per cent against mid, moderate and severe cases, the pharma company said in a statement. It added that the vaccine has an efficacy of 70 per cent in asymptomatic infection. Also read | Covaxin is effective against multiple variants of coronavirus: Indian medical body "Efficacy against SARS-Cov-2 has been established. Covaxin has demonstrated an excellent safety record in human clinical trials and in usage under emergency use. Covaxin is now a global innovator vaccine derived from R&D in India," Bharat BioTech Chairman and Managing Director Krishna Ella was quoted as saying by news agency PTI. Ella also said that the protocols for manufacturing, testing and release of inactivated vaccines meet the requirements of WHO, Indian, and other regulatory authorities. "These protocols have delivered consistent results over a 15-year period with more than 300 million doses supplied globally, with excellent safety and performance record," the MD said. The pharma company said final analysis results will be available in June and the final report will then be sent to a peer-reviewed publication. Covaxin has been jointly prepared by Bharat BioTech and ICMR. Balram Bhargava, Director General of ICMR and Secretary of Department of Health Research said that Covaxin "works well against" most variants of coronavirus.

Covaxin has an efficacy of 78% against severe Covid-19 cases: Bharat BioTech