Calf Serum Used In Manufacturing Process, Not In Final Product: COVAXIN Maker Bharat Biotech

Bharat Biotech, the maker of Covaxin, found itself in an unlikely controversy after messages started flooding on social media claiming the vaccine has serum of newborn calves.

The Hyderabad-based firm on Wednesday clarified that while newborn calf serum is used in the manufacturing of viral vaccines, the final formulation of its Covid-19 vaccine Covaxin is free from all impurities.

BCCL

For Vero Cells

"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," the company said in a statement.

"Covaxin is is highly purified to contain only the inactivated virus components by removing all other impurities," it added.

It also said that bovine serum is widely used in the manufacture of vaccines globally for several decades.

Bovine serum is widely used in the manufacture of vaccines globally for several decades. The usage of newborn calf serum was transparently documented in several publications including Hamster Efficacy Study over the last 9 months: Bharat Biotech

¡ª ANI (@ANI) June 16, 2021

It also stated that the usage of newborn calf serum was transparently documented in various publications for the last 9 months.

What RTI said

The controversy erupted after the government in an RTI reply stated that "As per information provided by firm, new born calf serum is used in revival process of Vero Cells which is used for the production of Corona Virus during the manufacturing of COVAXIN bulk vaccine of M/s Bharat Biotech."

FINALLY Govt. accepts that New Born Calf serum is used in COVAXIN.
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This Information Was Received By Vikas Patni After Filing RTI
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RTI PDF- https://t.co/SMzZCp9YgY pic.twitter.com/gwNqrQKhwW

¡ª cowsblike (@cowsblike) June 14, 2021

However, the government clarified that Covaxin does not contain newborn calf serum at all.

Government's clarification

"There have been some social media posts regarding composition of the Covaxin vaccine where it has been suggested that it contains the newborn calf serum. Facts have been twisted and misrepresented in these posts," said the Ministry.

"Newborn Calf Serum is used only for preparation or growth of vero cells."

BCCL

Noting that different kinds of bovine and other animal serum are standard enrichment ingredient, and they are used globally for vero cell growth, the Ministry said vero cells are used to establish cell lives which help in 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 newborn calf serum. Thereafter, these vero cells are infected with corona virus for viral growth.

BCCL

"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."

Hence, the Ministry said, 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.

Covaxin, the first indigenous COVID-19 vaccine was co-developed by Bharat Biotech and the Indian Council of Medical Research.