COVAXIN not made of calf serum, is part of manufacturing process – MoHFW and Bharat Biotech clarify

COVAXIN not made of calf serum, is part of manufacturing process – MoHFW and Bharat Biotech clarify

The Ministry of Health and Family Welfare and Bharat Biotech have clarified that the COVAXIN COVID-19 vaccine is not made of calf serum. The information about the indigenous vaccine stems from a Right to Information (RTI) petition filed in April. The petition has opened a metaphorical can of worms for the pharma company that made the vaccine. It is also being accused by some on social media to have withheld this information from the public. Both Bharat Biotech and the Health Ministry have denied these accusations.

While using calf serum is not surprising to those in the vaccine industry, it has come as a bit of a surprise to the general public.

Image credit: Bharat Biotech

Bharat Biotech has been accused of using bovine products in its vaccines and not making it known to the public. Image credit: Bharat Biotech

RTI plea

In an RTI petition submitted on 15 April 2021, to the Central Drugs Standard Control Organisation (CDSCO), Vikas Patni asked 12 questions seeking responses on topics ranging from the contents of the vaccine, its expiry date and side effects, laws restricting travel and government compensating to people who have adverse reactions, etc. Among these questions, Patni asked if Fetal Bovine Serum (FSB) was used, in any form, during the making of any of the vaccines.

CDSCO responded to all these questions. For the usage of FBS in the vaccine, the response was – “As per new information provided by the firm, newborn 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.”

Difference between Fetal Bovine Serum and New Born Calf Serum

One aspect of the debate is the use of Fetal Bovine Serum (FSB) and New Born Calf Serum (NBCS). Patni has asked if FSB was used while in reality NBCS was used in the process. There is a distinct difference between both these serums.

Fetal bovine serum (FBS) is taken from the blood drawn from a bovine fetus in a slaughterhouse. It is widely used for vaccine production because it has a very low level of antibodies and contains more growth factors.

Newborn Calf Serum (NBCS) originates from a calf that is three to 10 days old. This serum is of a higher quality and is a cost-effective replacement for FBS. It also has a higher proportion of proteins and immunoglobulin, but fewer growth factors.

Congress tweets

Before any agencies involved in the vaccine’s production responded to the claims, Gaurav Pandhi, the Congress Party’s National Coordinator for its Digital Communications & Social Media, tweeted. He said the vaccine consists of NBCS, which is “a portion of clotted blood” from a slaughtered calf. He also shared a screengrab of a document showing the difference between Fetal Bovine Serum (FBS) and New Born Calf Serum (NBCS).

In another tweet, Pandhi posted a video of him berating the government on first not providing enough vaccines and then betraying people’s faith. He said people had the right to know if calf serum was used in the vaccine.

However, he also insisted the people should get vaccinated keeping religion and faith aside, as they are a lifeline.

Health Ministry responds

The Ministry of Health and Family Welfare (MoHFW) came out in support of the indigenous vaccine. It said there is no calf serum in the vaccine itself and is just a product used during the making of the vaccine.

“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 Union Health Ministry said.

In an effort to clear out confusion and put an end to the spread of misinformation, MoHFW stated the NBCS is used only in the preparation of Vero cells for the vaccine. It also stated that the use of bovine and other animal serums is common and has been prevalent in the production of many vaccines for other diseases such as Polio, Rabies and Influenza as well.

When scientists started growing viruses in a lab, they had to recreate the same conditions that were found in a human body. They used solutions of sugars, salts, and various meat extracts to make this possible. They started using the Vero cells (which are kidney cells taken from the African green monkey; a technique developed in 1962). Vero cells are used as a vector to grow genetically engineered viruses. Since viruses cannot live without a host, these cells help them grow.

These cells are washed with water and chemicals multiple times to get rid of the NBCS. They are then used to develop the vaccine. During this process, the Vero cells are also destroyed when the virus is injected into it.

Later, the SARS-CoV-2 virus is also killed (deactivated) and purified, so there is no chance of infection for a person being vaccinated.

Bharat Biotech responds

In a statement, Bharat Biotech has responded to the accusations in an effort to clarify that the vaccine itself does not contain the serum. It said NBCS is used in manufacturing vaccines all over the world. However, they are not present in the vaccines administered to humans.

“It is used for the growth of cells, but is neither used in the 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.”

It also said the usage of NBCS has been documented in all its studies.

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