Covaxin Manufacturer's 'Excellent Safety Record' Message Amid Covishield Row Over 'Side-Effects'

Bharat Biotech lauding India's indigenous said it was the only vaccine in the country's immunisation program to have conducted efficacy trials in India.

Covaxin was evaluated in more than 27,000 subjects as part of its licensure process, Bharat Biotech said..

Amid the debate over Astra Zeneca's alleged side-effects, Bharat Biotech has said that Covaxin was developed with a single-minded focus on safety first, followed by efficacy.

The Covid vaccine maker lauding India's indigenous said it was the only vaccine in the country's immunisation program to have conducted efficacy trials in India.

In a statement released on Thursday, the company said, "Covaxin was the only COVID-19 vaccine in the Govt of India's COVID-19 immunisation program to have conducted efficacy trials in India. Covaxin was evaluated in more than 27,000 subjects as part of its licensure process."

The company said that the vaccine was licensed under restricted use in clinical trial mode and the safety of Covaxin was evalauted by the Ministry of Health.

@bharatbiotech announcement - #COVAXIN was developed with a single-minded focus on #safety first, followed by #efficacy. #BharatBiotech #COVID19 pic.twitter.com/DgO2hfKu4y

— Bharat Biotech (@BharatBiotech) May 2, 2024

"It was licensed under restricted use in clinical trial mode, where detailed safety reporting was carried out for several hundred thousand subjects. Safety of Covaxin was also evaluated by the Ministry of Health, Govt of India," the statement said. 

"Ongoing safety monitoring (pharmacovigilance) was continued throughout the product life cycle of Covaxin. All the above studies and safety follow-up activities have demonstrated an excellent safety record for Covaxin, without any vaccine associated incidents of blood clots, Thrombocytopenia, TTS, VITT, pericarditis, myocarditis, etc," it added. 

UK-headquartered pharmaceutical giant AstraZeneca, which was manufactured by the Serum Institute of India and marketed as Covishield, has admitted that in very rare cases, its Covid-19 vaccine can cause a blood clot-related side-effect but the causal link is unknown.

The Daily Telegraph reported that in a legal document submitted to the High Court in London in February for a group action brought by 51 claimants, AstraZeneca admitted that the vaccine developed with the University of Oxford to protect against COVID-19 may cause Thrombosis with Thrombocytopenia Syndrome (TTS) in very rare cases.

The AstraZeneca Vaxzevria vaccine, also manufactured by the Serum Institute of India, was marketed in India as Covishield.