The screenshot of a Right to Information (RTI) response from the Central Drugs Control Standard Organisation has gone viral, using which social media users have claimed that the Covaxin COVID-19 vaccine "contains" new born calf serum cells in it.
The claim then goes on to talk about the process of procurement of the serum and that this detail was "hidden" from people.
However, we found that the claim is misleading. While the Covaxin's COVID-19 vaccine does use newborn calf serum (NBCS), it is not present in the final product. NBCS is used to in preparation and growth of vero cell lines which is an important part in the production of the vaccine. The vero cells are then purified and treated to remove NBCS completely.
The RTI response that has gone viral was posted by a Vikas Patni, whose social media posts are full of anti-vaccination messages.
The question in the RTI query said, “Does vaccines procedures used FBS in making of corona vaccines in any form, composition or ingredient made by Bharat Biotech, Serum Insitute and approved by Indian Government or deparments?
The response said, "As per information provided by firm, new born calf serum is used in revival process of Vero Cells which is used for the production of Corona Virus during the manufacturing of COVAXIN bulk vaccine of M/s Bharat Biotech."
However, several social media users posted screenshots of this RTI to claim that new born calf serum was in the vaccine.
Gaurav Pandhi, National Co-ordinator, Digital Communications and Social Media for the Indian National Congress, also tweeted the same RTI response.
WHAT WE FOUND OUT
Why is Cattle Serum Used in Vaccines?
The use of cattle serum or blood is not a novel concept. It has been used since long to produce viral vaccines such as seasonal influenza, polio, pertussis, rabies and Japanese encephalitis - all of which use the inactivated virus platform.
Serum from calf or fetal blood is sometimes used in order to grow cells in laboratory settings and replicate the cells for future use and studies.
According to a document by the US Food and Drugs Administration on the use of bovine-derived materials in vaccine, "Although synthetic media have been developed for growth of many medically important microorganisms, 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."
We reached out to virologist Dr Jacob T John, who also said that the use of calf serum was common practice in virology.
What About Covaxin?
Covaxin, the India-made vaccine produced Bharat Biotech also falls in the category of inactivated vaccine, in which the pathogen is deactivated so it no longer infects anyone.
The vaccine was developed in collaboration with The Indian Council of Medical Research and National Institute of Virology, Pune.
According to the manufacturers and the ICMR, the vaccine is developed using Whole-Virion Inactivated Vero Cells derived platform technology.
To produce the vaccine, Vero CCL-81 cells are grown in the lab. For the cells to grow outside the body, they need conditions that will allow them to divide and turn into specific cell types required for the production of the vaccine. In case of Covaxin, Dulbecco’s Modified Eagle Medium (DMEM), combined with 5-10 percent newborn calf serum was used to provide essential nutrients required for cell division.
These vero cells are then purified using chemicals to make it free from the new born calf serum, following which they are exposed to the SARS-CoV-2 virus in bioreactors under controlled conditions.
The virus is then harvested, inactivated and mixed with adjuvants, surfactants, residuals, diluents and stabilisers to produce the final product.
According to the fact sheet provided by Bharat Biotech, the Covaxin vaccine is made up of 6µg of whole-virion inactivated SARS-CoV-2 antigen (Strain: NIV-2020-770), and the other inactive ingredients such as aluminum hydroxide gel, TLR 7/8 agonist (imidazoquinolinone, TM 2-phenoxyethanol, and phosphate buffer saline.
“I don’t think the final product will ever have any serum in it because we don’t want any allergic reactions from the serum. Therefore, it has to be purified. So, in the last stage of the virus fermenter, there will not be any serum at all.”Dr Jacob T John, Virologist
Was The Use of Cattle Serum a Secret?
Contrary to what several social media users, including Pandhi claimed, the information on the use of NBCS has been in public domain since September 2020, when ICMR and Bharat Biotech released a preclinical study on Covaxin.
Are Calves Slaughtered to Extract Serum?
Foetal Bovine Serum (FSB) was widely used to produce vaccine previously. However, due to ethical concerns, scientists shifted to using NCBS.
Claims that Covaxin and Covishield uses FBS were shared widely last years, which was debunked by FIT here.
The claim on slaughtering of calves for deriving calf serum is partially true. Both fetal serum and NBCS are by products of cattle industry and hence easily available from countries like the USA, New Zealand and Australia where extensive cattle farming is carried out. India also imports cattle serum in huge quantities every year.
However, Dr John explained that the calves don't have to be slaughtered to derive the serum. The serum is derived from the new born calf before it starts drinking milk from its mother. That ensures that no anti-bodies are present in the serum which could hamper the vaccine production process. The calves can then be reared if the farmers choose to do that. However, male calves are not of much use to the farmers and they choose to slaughter them after the extraction of the serum.
Other methods of providing nutrition to the cells artificially, thus replacing cattle serum, are also present but they are expensive and required specialised labratories.
Ministry of Health and Bharat Biotech Issue Clarifications
After claims about the use of NCBS went viral, both the Ministry of Health and Bharat Biotech issued clarifications on how it is used.
"Newborn Calf Serum is used only for preparation/ growth of vero cells. 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," read the press note issued by the Ministry of Health and Family Welfare.
"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 press note added.
Bharat Biotech in a statement to the press said, "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."
Evidently, misleading claims about the use of cattle serum in Covaxin COVID-19 vaccine were shared to create a false narrative and spread vaccine hesitancy.
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