Refuting rumours spread by some social media posts about the use of newborn calf serum in Covaxin, the Union government on Wednesday clarified that the coronavirus (COVID) vaccine manufactured by Bharat Biotech Ltd, does not contain newborn calf serum.
Giving clarification on the issue, Dr Harsh Vardhan, minister for health and family welfare, science and tech, and earth sciences, says, "Final vaccine product of Covaxin does not contain newborn calf serum. Claims suggesting otherwise are misrepresenting facts. Animal serum has been used in the vaccine manufacturing process for decades, but it is completely removed from the end product."
In a release, the ministry of health and family welfare (MoHFW) says, "There have been some social media posts regarding the composition of Covaxin where it has been suggested that it contains new born calf serum. Facts have been twisted and misrepresented in these posts."
Replying to the RTI filed by Mr Patni, the Central Drugs Standard Control Organisation (CDSCO), which is India's national regulatory body for pharmaceuticals and medical devices, had said, "As per information provided by the firm, new born calf serum is used in the revival process of Vero cells, which is used for the production of coronavirus during the manufacturing of Covaxin bulk vaccine of Bharat Biotech."
Noting that different kinds of bovine and other animal serum are standard enrichment ingredient, and that they are used globally for Vero cell growth, the health ministry says Vero cells are used to establish cell lives which help in the production of vaccines.
This technique has been used for decades in polio, rabies and influenza vaccines.
These Vero cells, after the growth, are washed with water, with chemicals, also technically known as buffer, many times to make it free from the new born calf serum. Thereafter, these Vero cells are infected with corona virus for viral growth.
The ministry says, "The Vero cells are completely destroyed in the process of viral growth. Thereafter this grown virus is also killed (inactivated) and purified. This killed virus is then used to make the final vaccine, and in the final vaccine formulation no calf serum is used."
Meanwhile, Bharat Biotech, the manufacture of Covaxin also clarified that while new born calf serum is used in the manufacturing of viral vaccines, the final formulation of its COVID-19 vaccine is free from all impurities.
In a statement, the company says, "New born calf serum is used in the manufacturing of viral vaccines. It is used for the growth of cells, but neither used in growth of SARS CoV2 virus nor in the final formulation."
"Covaxin is highly purified to contain only the inactivated virus components by removing all other impurities," it added.
Vero cells, also known as African green monkey kidney cells, were officially isolated from African green monkey kidneys by Japanese scholars Yasumura Y and Kawakita Y in 1962. It was the first aneuploidy attachment-dependent cell used in producing human biological products and establishing cell lines and cell banks of different generations at the same time, says a report from AcceGen Biotechnology
Thus, the final vaccine Covaxin does not contain newborn calf serum at all and the calf serum is not an ingredient of the final vaccine product, the ministry says.
Covaxin is India's first indigenously developed COVID-19 vaccine manufactured by Bharat Biotech and is being used on adults in the vaccination drive since 16th January this year.