Bharat Biotech uses 'calf serum' to make Covaxin? Experts call it 'standard practice'

Is newborn calf serum used to make Bharat Biotech's Covaxin? An RTI reply to applicant Vikas Patni suggests so. The "newborn calf serum is used in the revival process of Vero cells, which is further used for the production of coronavirus during the manufacturing of Covaxin," Bharat Biotech in a reply to the Central Drugs Standard Control Organisation (CDSCO) has said. The RTI asked if vaccine producers used fetal bovine serum (FBS) in making coronavirus vaccines. Bharat Biotech did not respond to BT's queries until this story was published.

Experts say newborn calf serum is used by all viral vaccine makers as a standard practice. "The vaccine will not have the presence of any calf sera. In other words, it is not used to make vaccines, but as an agent to grow the cell. After that, cell is purified and a virus is introduced into that cell. This is where the virus multiplies, it is harvested and killed. A similar process happens in polio vaccine manufacturing too. It is used by all viral vaccine manufacturers in India," a senior industry official told BusinessToday.In.

The reports of "newborn calf serum" in the vaccine making process come amid several conspiracy theories. Misinformation is on the rise when it comes to Covid-19 vaccines, with many claiming a jab can cause death, while others say there's presence of microchips in doses.

Another study shared along with the RTI query suggests serum is derived from "healthy and slaughtered bovine calves". Newborn calf serum is the "liquid fraction of clotted blood derived from healthy, slaughtered bovine calves aged less than 20 days, deemed fit for human consumption via ante or post-mortem inspection," it says. This was explained in a research paper 'A Method for Differentiating Fetal Bovine Serum from Newborn Calf Serum,' written by Michelle Cheever, Alyssa Master, and Rosemary Versteegen, in Bioprocessing Journal.

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Notably, an animal study conducted by Bharat Biotech in 2020 had also indicated the company uses newborn calf serum in making vaccines. The research paper, released by the Indian Council of Medical Research and Bharat Biotech, said blood serum from newborn cattle is one of the ingredients used in making Covaxin.

To produce vaccines, Vero cells are developed by experts in the lab and exposed to the Covid-19 virus in bioreactors. After harvesting the virus for 36 hours, it is inactivated and mixed with adjuvants that boost the immune system. This adjuvant identifies RNA from viruses. Bharat Biotech's Covaxin is also an inactivated vaccine.

Also read: Bharat Biotech says Rs 150 per dose for Covaxin a 'non-competitive price', 'not sustainable'

Twitter is abuzz after the "RTI reply" was shared on the platform, with people asking if companies extract serum "by killing the calf". However, many have tried to dispel the misinformation, saying blood is either taken from a living calf or imported from slaughterhouses from outside of India.

Meanwhile, Patni, among other questions, also asked if there's any compensation for somebody if he or she has an adverse reaction, disability or death by vaccination. The CDSCO replied saying there is no provision under the Drugs and Cosmetics Act and Rules for providing compensation due to side-effects, disability and deaths after approval of vaccines.

Also read: US FDA rejects emergency use approval for Bharat Biotech's Covaxin