During the ongoing debate regarding AstraZeneca’s acknowledgment of “rare” side effects from its Covid-19 vaccine, known as Covishield in India, Bharat Biotech, the developer of Covaxin, highlighted its vaccine’s safety record.
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Bharat Biotech released a statement on its X handle, stating that it developed Covaxin with an unwavering emphasis on prioritizing safety first, followed by efficacy.
The vaccine maker also mentioned that Covaxin conducted efficacy trials in India, making it the only Covid-19 vaccine in the government’s Covid-19 immunization program to do so.
Bharat Biotech stated that they evaluated Covaxin in over 27,000 subjects during its licensure process. It received licensing under restricted use in clinical trial mode, which involved detailed safety reporting for several hundred thousand subjects.
Covaxin Holds ‘Excellent Safety Record’
The Ministry of Health, Government of India, also evaluated the safety of Covaxin, according to the statement. Ongoing safety monitoring (pharmacovigilance) continued throughout Covaxin’s product life cycle.
The company stated that studies and follow-up activities have shown Covaxin to have an “excellent safety record.” They reported no incidents of vaccine-associated issues such as blood clots, Thrombocytopenia, pericarditis, and myocarditis.
The Bharat Biotech team, seasoned innovators and product developers, acknowledged that while the efficacy of Covid-19 vaccines might diminish over time, the impact on patient safety could be long-lasting. Therefore, they prioritize safety as the primary focus for all their vaccines.
In recent developments, AstraZeneca, in court documents, acknowledged for the first time that its Covid-19 vaccine could cause a blood clot-related side effect in “very rare cases.” The vaccine, marketed globally as Covishield and Vaxzevria among other names, was the subject of this admission.
The Serum Institute of India (SII) marketed the AstraZeneca vaccine as Covishield in India.
A class-action lawsuit was filed against the pharmaceutical company, alleging serious injuries and deaths caused by its vaccine, developed in partnership with the University of Oxford.
Jamie Scott initiated the lawsuit after suffering a permanent brain injury from the AstraZeneca vaccine in April 2021.
His case, among others, underscores the severe impact of a rare side effect called Thrombosis with Thrombocytopenia Syndrome (TTS), characterized by blood clots and low platelet counts.
