NEW DELHI: Bharat Biotech on Thursday assured
Covaxin
‘s
safety
amid debate over
Astrazeneca
‘s admission that its Covid-19
vaccine
, sold as
Covishield
in India, could cause “rare’ side effects.
The vaccine company posted a statement on X, mentioning that Covaxin was the sole Covid-19 vaccine in the government’s Covid-19 immunisation programme to have conducted efficacy trials in India.
The vaccine manufacturer mentioned that Covaxin was created with a primary focus on safety before considering efficacy.
“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,” Bharat Biotech said.
“Safety of Covaxin was also evaluated by the Ministry of Health, Government of India. Continuous safety monitoring (pharmacovigilance) was maintained during the entire product life cycle of Covaxin.
The company said that studies and follow-up activities demonstrated its “excellent safety record’ for Covaxin and that there were no reports of vaccine-associated incidents, including blood clots, Thrombocytopenia, pericarditis and myocarditis.
“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. Therefore, safety is the main priority for all of our vaccines.
Recently, AstraZeneca admitted for the first time in court documents that its Covid-19 vaccine, in “very rare cases’, could cause a blood clot-related side effect. The Covid-19 vaccine developed by AstraZeneca was distributed worldwide under various brand names including Covishield and Vaxzevria.
The AstraZeneca vaccine, which was manufactured by the Serum Institute of India (SII), was marketed in India under the name Covishield.
The pharmaceutical company was dealing with a legal case that claimed there were severe injuries and fatalities linked to its vaccine, which was created in partnership with the University of Oxford.
Jamie Scott initiated the lawsuit because he suffered a permanent brain injury after getting the AstraZeneca vaccine in April 2021.
His case, among others, touches upon the effect of Thrombosis with Thrombocytopenia Syndrome (TTS), which is characterised by the presence of blood clots and low platelet counts.
(with input from agencies)
