Amidst vaccine hesitancy in certain sections of the population and the concerns about the COVID-19 vaccines, a post based on Congress’s Gaurav Pandhi’s Tweet of an RTI response is going viral. The post claims that Bharath Biotech’s Covaxin contains Newborn Calf Serum (NBCS). Let us now verify the claims in this post.
Claim: Bharath Biotech’s Covaxin contains Newborn Calf Serum (NBCS).
Fact: Bharath Biotech’s Covaxin does not contain Newborn Calf Serum (NBCS). The government issued an official statement that NBCS was used only as a building block in the vaccine development for the growth of Vero cells and is not an ingredient in the final vaccine. Hence, the claim made in the post is FALSE.
Bharat Biotech’s Covaxin uses a purified and inactivated (killed) virus approach to help the body build an immune response against COVID-19. An RTI petition was submitted to the Central Drugs Standard Control Organisation (CDSCO) on 15 April 2021, where a person asked 12 questions including if the vaccine manufacturing involved the use of Fetal Bovine Serum (FBS) in any form, composition, or as an ingredient. The question was about both the vaccines made by Bharath Biotech and Serum Institute. The response to the RTI sparked controversy around the use of Newborn Calf Serum (NBCS), a procedure where clotted blood is extracted from young calves. Some Hindus have expressed their concern in the past over the contents of Covaxin currently being rolled out in India. The crux of their apprehension is whether the vaccines contain cattle blood, since Cow is revered by Hindus.
What is FBS?
In order to grow cells in laboratory settings for vaccine research, serum from calf or fetal blood is sometimes used. It helps cells grow and replicate so they can be studied. This technique has been used for decades in Polio, Rabies, and Influenza vaccines. Fetal Bovine Serum (FBS) provides all the necessary nutrients for a cell to grow outside of an animal. Its successful application in cell culture led to widespread use in drug and vaccine manufacturing. FBS is collected through slaughtering a pregnant cow and further puncturing the heart of the fetus to collect the blood.
The study on the Hamster model of Bharat Biotech’s COVID-19 vaccine does refer to the usage of 2% of Fetal Bovine Serum (FBS) for the growth of Vero cells. However, Bharath Biotech has developed and assessed the protective efficacy and immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in rhesus macaques (Macaca mulatta), closest to human beings, according to this study.
Therefore, in the finalized method (rhesus macaques), 2% of FBS was used for virus isolation but not in the generation of the Vero Cells. Bharath Biotech’s Covaxin does mention the use of Dulbecco’s Modified Eagle Medium (DMEM), along with 5-10 per cent new-born bovine calf serum (NBCS) for the revival of Vero cells. The serum is extremely rich in growth factors. The blood is collected from new-born calves, within 14 days after the birth. Thus, this NBCS is not the same as Fetal Bovine Serum (FBS) that is mentioned in the RTI plea since scientists have stopped using FBS owing to ethical concerns and cruelty of the process. And hence even the NBCS is only used in the development of Vero cells and not in the making of the final vaccine.
Additionally, given that Bharath Biotech has published the list of ingredients that have been used to make Covaxin, it is clear that there has been no use of blood serum of newborn cattle in the final vaccine.
An official statement from the Ministry of Health & Family Welfare also clarified that the NBCS is used only for the preparation of the Vero cell that is later completely destroyed in the process of viral growth. Therefore, the final Covaxin vaccine does not contain newborn calf serum at all.
At the same time, there seems to exist a difference of opinion on how the NBCS is extracted. There are conflicting reports on whether there is cruelty involved or not in the process of extraction of NBCS. One report said the blood is collected from calves that are less than 10 days old (there is no mention of dead or alive) and another report said the blood was likely collected from a newborn calf in the form of a cardiac puncture.