Responding to an RTI reply that has stirred a controversy, the Hyderabad-based Bharat Biotech on June 16, Wednesday issued a statement saying that the final Covaxin dose administered to people does not have newborn calf serum. The controversy began a day earlier, when an RTI filed by a person identified as Vikas Patni revealed that new calf serum has been used in revival of vero cells which is used for the production of Covaxin.
In a statement issued on June 16, Wednesday, Bharat Biotech said, “Newborn 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.”
The company added that Bovine serum has been widely used in the manufacture of vaccines globally for several decades. “The usage of new born calf serum was transparently documented in the following publications since the last 9 months,” the company added.The Union Health Ministry on Wednesday also issued a clarification, stating that while the serum is used only for the manufacturing of vaccines, the final vaccine does not contain newborn calf serum at all. The Union Ministry of Health and Family Welfare added that facts have been “twisted and misrepresented” in social media posts regarding composition of the vaccine and the suggestion that Covaxin contains newborn calf serum is not correct.
“Newborn Calf Serum is used only for preparation/ growth of vero cells. Different kinds of bovine and other animal serum are standard enrichment ingredients used globally for vero cell growth. 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,” the Union government said in a release.
“These vero cells, after the growth, are washed with water, with chemicals (also technically known as a buffer), many times to make it free from the newborn calf serum. Thereafter, these vero cells are infected with coronavirus for viral growth,” the government added.
The government added that these vero cells are completely destroyed in the process of viral growth and so 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, the health ministry said.
“Hence, 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 Union government said.
After the RTI response surfaced, many social media users, especially the Congress party, expressed their objections over the vaccine, a development which could further accelerate vaccine hesitancy prevalent in the country.
Gaurav Pandhi, a member of the Congress party, said that the use of the new calf’s serum in the vaccine was ‘heinous.’
However, Dr Sumaiya Shaik, a neuroscience doctor, clarified that animals are not killed to derive blood serum for Covaxin. “Either the blood is taken from alive calf or (usually the case) imported from slaughter houses from outside of India. Moreover, no amount of calf/cow is actually in the vaccine, it is only needed to produce it (sic),” she said.