‘Safety is primary focus for all our vaccines’: Covaxin-developer Bharat Biotech

NEW DELHI: Amid reports over potential rare side effects of the AstraZeneca-Oxford Covid-19 vaccine, Bharat Biotech, which developed the Covaxin, said in a statement that the vaccine was developed with a “single-minded focus on safety first.”

It stated that Covaxin was the “only Covid vaccine” in government of India’s COVID-19 immunisation program to have conducted efficacy trials in India. “@bharatbiotech announcement – #COVAXIN was developed with a single-minded focus on #safety first, followed by #efficacy,” Bharat Biotech stated in a post on X.

@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

Notably, Covidshield and Covaxin were the vaccines, that were primarily administered in India during the Covid pandemic.

Bharat Biotech, further said in its statement that 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.

Safety of Covaxin was also evaluated by the Ministry of Health, Govt of India. 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.

“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,” the statement added.

This comes in the wake of a recent admission by AstraZeneca, the pharmaceutical company, that its Covid vaccine Covishield and Vaxzevria “can, in very rare cases, cause Thrombosis Thrombocytopenia Syndrome (TTS).”

According to several UK media reports, AstraZeneca has 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.

Following the reports, an AstraZeneca spokesperson stated, “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”.

The Serum Institute of India produced Covid-19 vaccine named Covishield, but not using mRNA platform. It has been prepared using the viral vector platform. In the vaccine, a chimpanzee adenovirus — ChAdOx1 — has been modified to enable it to carry the Covid-19 spike protein into the cells of humans. This cold virus is basically incapable of infecting the receiver, but can very well teach the immune system to prepare a mechanism against such viruses. (ANI)