On June 15, Congress leader Gaurav Pandhi shared a document on Twitter claiming that Bharat Biotech’s COVAXIN contains newborn calf serum obtained after slaughtering 20-days-old calves. In a tweet, he wrote, In an RTI response, the Modi Govt has admitted that COVAXIN consists of Newborn Calf Serum… which is a portion of clotted blood obtained from less than 20 days young cow-calves, after slaughtering them. THIS IS HEINOUS! This information should have been made public before.” The said RTI has been making rounds on social media for several days.

Pandhi is the Digital Communications & Social Media National Coordinator of Congress.

There are several aspects of the said information provided in the RTI that need to be considered and discussed. First of all, this is not the first time Newborn Calf Serum is being used in the process of vaccine production. It is used in a standard procedure to produce cells to culture viruses and other pathogens to develop vaccines. Secondly, neither Bharat Biotech nor the Government of India ever hid the information on the use of serum in the manufacturing process.

Govt of India busts the myth

In a press release the Ministry of Health and Family Welfare refuted the claims that Covaxin has newborn calf serum. It said that the serum was used only for the growth of vero cells. It states, “There have been some social media posts regarding composition of the COVAXIN vaccine where it has been suggested that COVAXIN vaccine contains the newborn calf serum. Facts have been twisted and misrepresented in these posts.”

It further added, “Newborn Calf Serum is used only for preparation/ growth of vero cells. Different kinds of bovine and other animal serum are standard enrichment ingredient 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.

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.

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 final vaccine (COVAXIN) does not contain newborn calf serum at all and the calf serum is not an ingredient of the final vaccine product.”

What is Newborn Calf Serum, and how is it different from Fetal Bovine Serum?

While Fetal Bovine Serum is obtained from the blood of fetuses' from a healthy slaughtered bovine, Newborn Calf Serum is the liquid fraction of clotted blood derived from healthy, slaughtered bovine calves aged less than 20 days. Both are collected in abattoirs inspected by the competent authorities of the country of origin. The blood for production of newborn calf serum can be obtained from live animal as well without slaughtering it.

Producers of the serum

US, Australia, New Zealand, Mexico and Costa Rica are the largest producers of Newborn Calf Serum. Notably, due to the high standards of the products, the majority of the vaccine manufacturers prefer to use serum produced in the US, Australia or New Zealand. India does not produce the serum as there is a ban on cow slaughter in the country. The vaccine manufacturers import the serum from countries like the US to use it to culture cells in the lab.

Use of serum in Covaxin

According to a paper from September 2020 titled “Immunogenicity and protective efficacy of BBV152: a whole virion inactivated SARS CoV-2 vaccine in the Syrian hamster model” published before the first phase of the vaccine trial, it was mentioned that the vaccine used newborn calf serum. It reads, “Vero CCL81 cells were grown in Minimum Essential Media (MEM) (Thermo she Scientific, USA) supplemented with 2% foetal bovine serum (FBS) (Sigma-Aldrich, USA).” BBV152 is the codename of Covaxin. The research paper is available on ICMR’s website.

Notably, during vaccine production, Vero cells are developed by the scientists in the lab and exposed to the Covid-19 virus in bioreactors. Once the virus is collected, it is inactivated and mixed with adjuvants to boost the immune system. Adjuvant helps in identifying RNA from viruses. Covaxin by Bharat Biotech is based on the same principle of the inactivated virus strain.

It is understandable that to grow cells in a lab, scientists need to provide conditions that can boost the division and production of specific cell types. According to a report from September 2020, Covaxin uses Dulbecco’s Modified Eagle Medium (DMEM), along with 5-10 per cent newborn calf serum. The said serum is NOT part of the vaccine but part of the process used to develop cells to grow the virus in a controlled environment. Notably, similar cells are also used in Polio, Rabies, and Influenza vaccines.

The Ethical Dilemma

There was a time when cow foetus serum was extensively used as it is rich in growth factors. However, the process of obtaining the serum was deemed cruel by the animal rights advocates. Due to the ethical dilemmas and cruelty of the process, a shift was made to the blood collected from the calf within 3-10 days of its birth. The antibodies that the calf develops during this period can be neutralized by heating the serum for a specific period of time.

Notably, synthetic growth material have been developed for cell production in labs, FDA suggests “some still require additional nutrients which are easily provided by animal-derived products such as serum and blood. Viral vaccines are produced in living cells, which, similarly, require the addition of complex growth media components, such as fetal calf serum.”

What do experts say?

Anand Ranganathan, Associate Professor, Special Centre for Molecular Medicine, Jawaharlal Nehru University, Delhi, quoted Pandhi and said, “Calf serum is used ONLY for growing cells to make more of the virus. Covaxin does NOT contain Calf serum.” He further added that the information was available in the public domain since September 2020.

Dr Amit Thadhani, practising surgeon, said, “Why does Congress keep complete science illiterates as their spokespersons? It is used for cell cultures, the vaccine does not contain blood. Using calf serum to improve cell cultures is a common practice across several vaccines, not only Covaxin.”

The claims that the vaccine contains newborn calf serum are baseless. The serum is only used to culture cells so that virus can be produced in a controlled environment to create a vaccine. Moreover, going by Pandhi’s logic, anyone who eats vegetables is eating manure and soil as these are used to provide the required nutrition to the plant to produce the vegetables.