Every batch of Covaxin, the indigenous vaccine against Covid-19 developed by Hyderabad-based Bharat Biotech, undergoes over 200 quality-control tests and then the samples are submitted to the Central Drugs Laboratory. Only after the approval of the CDL, these batches are released commercially, the company said on Thursday issuing a statement in the wake of quality concerns of the vaccine.
In a recent interview, the chief of National Immunisation Technical Advisory Group, Dr NK Arora, said the initial batches of Covaxin, produced at the new plant of the company in Bengaluru were not satisfactory level. While he was explaining why there was a delay in getting the expected number of doses from Bharat Biotech, his statement was misinterpreted and concerns were raised over the quality of the initial batches of Covaxin. Later, it was clarified that those batches were never released and now Bharat Biotech too has issued a statement.
Citing its credentials, the company said that it is “emblematic” that Bharat Biotech has not sought indemnity from the government for any adverse events from Covaxin. “The whole-virion Inactivated Vero Cell vaccines are highly complex to manufacture as the critical ingredient is based on live viruses which require highly sophisticated, multiple level containment and purification methods. Such extensive, high standards of purification naturally lead to significant process losses and low yields resulting in a highly purified and safe vaccine,” the company said.
News Source : Business Standard
