Bharat Biotech asserts Covaxin’s safety amid AstraZeneca questions

Hyderabad-based Bharat Biotech on Thursday said its covid-19 vaccine, Covaxin, is safe and has shown no recorded incidents of blood clots, thrombocytopenia, TTS, VITT, pericarditis, or myocarditis.

Bharat Biotech’s assertion came against the backdrop of AstraZeneca’s submission in a United Kingdom court that its vaccine could “in very rare cases” cause Thrombosis Thrombocytopenia Syndrome, or TTS.

“Covaxin has demonstrated an excellent safety record and the vaccine is without any vaccine-associated incidents,” Bharat Biotech International Ltd (BBIL) said in a statement. 

The company said Covaxin was developed “with a single-minded focus on safety, followed by efficacy.” 

The Union health ministry evaluated the vaccine’s safety and that Covaxin was the only covid vaccine in the government of India’s immunization program to have conducted efficacy trials in India and was assessed in more than 27,000 subjects as part of its licensure process, it said. 

The company claimed that its vaccine was licensed under restricted use in clinical trial mode where detailed safety reporting was carried out for several thousand subjects. The ongoing safety monitoring (pharmacovigilance) continued throughout the product life cycle of the vaccine, the Krishna Ella-led company said. 

The statement further said that 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.

Bharat Biotech, which owns 215 patents, claims to have delivered 9 billion vaccines since its inception in 1996. 

The company’s statement comes after AstraZeneca shared details of the vaccine’s side effects in a British court following a suit linking its vaccine to death and severe injury in dozens of cases. 

According to reports carried by British media, the link between the vaccines and blood clot-related side effects is not established. 

Following the lawsuit in the UK, a plea has been filed in the Supreme Court urging the formation of a panel of medical experts headed by a retired Supreme Court judge to analyze the side effects and risk factors of the Covishield vaccine.

In India, Pune-based Serum Institute produced its version of AstraZeneca’s Vaxzevria  vaccine under the brand name Covishield.