The safety of Covaxin was also evaluated by the Ministry of Health, said the company.
The Covaxin was developed with a single-minded focus on safety first, said its maker Bharat Biotech on Thursday, days after British pharma giant AstraZeneca admitted that its Covid vaccine can cause rare side effects.
The Hyderabad-based Bharat Biotech underlined that Covaxin was the only Covid-19 vaccine in the Indian government's Covid-19 immunisation programme to have conducted efficacy trials in India.
"Covaxin was evaluated in more than 27,000 subjects as part of its licensure process. It was licensed under restricted use in clinical trial mode, where detailed safety reporting was carried out for several hundred thousand subjects," the vaccine manufacturer said.
The safety of Covaxin was also evaluated by the Ministry of Health, said the company.
"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 said.
"As seasoned innovators and product developers, the Bharat Biotech team was well aware that, while the efficacy of Covid-19 vaccines may be short-lived, the impact on patient safety could last a lifetime. Hence safety is the primary focus for all our vaccines," it added.
Covidshield and Covaxin were the vaccines that were primarily administered in India during the Covid pandemic.
According to several UK media reports, AstraZeneca had made the admission in court documents in connection with a case that alleges that the vaccine, developed with the University of Oxford, caused death and serious injury in dozens of cases.
"Our sympathy goes out to anyone who has lost loved ones or reported health problems. Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines," said an AstraZeneca spokesperson following the reports.