Bharat Biotech and the Ministry of Health and Family Welfare have refuted viral claims that the indigenously produced Covaxin contains new born calf serum cells in it.
Both the vaccine manufacturer and the Ministry clarified that new born calf serum is used in producing the vaccine but is not a part of the final product as it is removed through several rounds of vaccine purification.
According to this RTI filed by Vikas Patni with the Central Drugs Standard Control Organisation, Covaxin uses new born calf serum in its production of the inactivated SARS-CoV-2 vaccine which it is producing in collaboration with the Indian Council of Medical Research and National Institute of Virology.
Patni asked the CDSCO if fetal bovine serum was present in either Covaxin or Covishield and if the drug regulator approved the vaccine even after knowing that it was used in the vaccine. While the CDSCO replied that Covaxin used new born calf serum for the growth of Vero cells, it did not explain the definition of these cells.
After the RTI was shared online, several Twitter users starting sharing the RTI along with claims that calves as young as 20 days were being slaughtered for obtaining the serum and the government hid this from the citizens of the country. One of them was Gaurav Pandhi, National Co-ordinator, Digital Communications and Social Media for the Indian National Congress. View archive of his tweet here. This, however, is false.
Bharat Biotech and Ministry Response
The Ministry of Health and Family Welfare denied this claim by explaining the role of new born calf serum in the growth of vaccines. They further explained that it is used in vero cells which are cell lines extracted from a monkey kidney cell in 1962 and are still reproducing, further helping in different cells to interact with it and grow.
The Ministry also stated that different kinds of bovine and animal serum are globally used as enrichment ingredients which help in the faster and better growth of cell lines that will further assist in the growth of vaccines. To ensure that the SARS-CoV-2 has no traces of new born calf serum, the vero cells are washed with water and other buffers repeatedly to eliminate the bovine serum.
Only after ensuring that the vero cell is purified, SARS- CoV-2 is allowed to interact with the cell and grow in it. It is later inactivated, thus killing the vero cell, too. The vaccine final product that is administered to the people does not contain any new born calf serum.
Bharat Biotech released a statement on the same lines and also shared all the publications where they mentioned they had used new born calf serum and also worked on its removal.
"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. Bovine serum is widely used in the manufacture of vaccines globally for several decades. The usage of new born calf serum was transparently documented in five publications since the last 9 months," read their statement.
Use Of Bovine Serum In Vaccination
Bovine serum, as discussed earlier, is used widely for manufacturing vaccines. Earlier, it was carried out by slaughtering pregnant cows to obtain fetal cells but recently after the rise in ethical and moral questions, the serum is taken from young calves as it helps in antibody generation and growth. Serum removed from calves who are 14 weeks old or younger is classified as new born calf serum.
Fetal bovine cells are also a by-product of the beef industry and are mostly imported from countries like Australia and New Zealand that have a thriving dairy and beef industry.
New born calf serum is also a cost-effective replacement to fetal bovine serum and is more easily available. A research paper highlighted that new born calf serum is a cheaper substitute to fetal calf serum as it impacts the growth and maturation of cells as effectively as fetal cells do.