Amid global scrutiny surrounding AstraZeneca’s coronavirus jab due to rare side effects, Bharat Biotech on Thursday released a statement about the indigenous Covaxin saying it is safe and devoid of any side effects.
The company issued a press release in “public interest”, confidently asserting its safety and absence of any side effects, including Thrombosis with Thrombocytopenia Syndrome (TTS) – a rare side effect associated with AstraZeneca’s vaccine sold under the brand name Covishield in India. According to the press release, Covaxin – India’s first indigenous Covid-19 vaccine – was developed with a “single-minded focus on safety first, followed by efficacy”.
The vaccine maker said all the studies and safety follow-up activities have demonstrated an “excellent safety record, without any vaccine-associated incidents of blood clots, thrombocytopenia, TTS, vaccine-induced immune thrombotic thrombocytopenia (VITT), pericarditis, myocarditis, etc”.
Calling themselves “seasoned innovators and product developers”, the press release said Bharat Biotech’s 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 said.
Bharat Biotech released the statement after AstraZeneca admitted in a legal document submitted to the high court in London in February that its vaccine may lead to TTS in “very rare cases”.
“Covaxin was the only Covid-19 vaccine in the government of India’s Covid-19 immunisation programme to have conducted efficacy trials in India,” the company said, while adding that the vaccine was evaluated in more than 27,000 subjects as part of its licensure process.
The company further said it was licensed under restricted use in clinical trial mode, where detailed safety reporting was carried out for several hundred thousand subjects. The press release has also listed its safety profile.
“Safety of Covaxin was also evaluated by the ministry of health. Ongoing safety monitoring (pharmacovigilance) was continued throughout the product life cycle of Covaxin,” the press release said.
Covaxin is an inactivated virus-based coronavirus vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). It gained emergency use authorisation in India in January 2021 along with Serum Institute of India’s Covishield, allowing for its deployment in the vaccination drive during the pandemic.
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