Calf serum absent in COVAXIN, involved in development, government clarifies
COVAXIN, the indigenous COVID-19 vaccine produced by Bharat Biotech, does not contain calf serum, the Union Health Ministry clarified on Wednesday. The Ministry said newborn calf serum is only used in the development process of the vaccine. The presence of calf serum had sparked controversy after Gaurav Pandhi of the Indian National Congress tweeted (now deleted) an RTI response detailing the vaccine's development process.
'Technique has been used for decades in other vaccines'
The Ministry said, "Newborn calf serum is used only for preparation/growth of Vero cells. Different kinds of bovine and other animal serum are standard enrichment ingredients used globally for Vero cell growth." It added, "Vero cells are used to establish cell lives which help in the production of vaccines. This technique has been used for decades in Polio, Rabies, and Influenza vaccines."
'No calf serum in final formulation'
After the Vero cells are grown, they are washed with a buffer solution which removes the residual calf serum, the Ministry said. These cells are then infected with SARS-CoV-2 for viral growth, which is followed by the inactivation of the virus cells. This inactivated (killed) virus is used to make the final vaccine and "in the final vaccine formulation no calf serum is used."
'Facts have been twisted and misrepresented,' says Ministry
"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," the Ministry said. "Facts have been twisted and misrepresented in these posts," it said, referring to Pandhi's posts.
Controversy erupted after RTI reply mentioned use of calf serum
On Tuesday, Gaurav Pandhi shared an RTI document that sought to answer whether the development process of any COVID-19 vaccine used FBS (fetal bovine serum) "in any form, composition, or ingredient." The government's response stated, "Newborn calf serum is used in the revival process of Vero cells which is used for the production of the coronavirus during the manufacturing of COVAXIN bulk vaccine."
'This is heinous!' Pandhi had tweeted
Pandhi tweeted, "The Modi Govt has admitted that COVAXIN consists 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 (sic)."
Use of calf serum transparent since last year
However, the use of newborn calf serum in the development process of the vaccine, even if absent from the final product, bothered some. Cows are considered sacred among Hindus and their consumption or slaughter is taboo. Some Twitter users continued to criticize the government for not making this information public. The information has been available in the public domain since at least September 2020.
Calf serum not used in SARS-CoV-2 growth, final formulation: Manufacturer
Earlier, the vaccine manufacturer Bharat Biotech had also released a statement: "Newborn calf serum is used in the manufacturing of viral vaccines. It is used for the growth of cells, but (it is) neither used in the growth of the SARS-CoV-2 virus, nor in the final formulation." "COVAXIN is highly purified to contain only the inactivated virus components by removing all other impurities."
'Bovine serum used widely in vaccine manufacturing'
Bharat Biotech further said in the statement, "Bovine serum is widely used in the manufacture of vaccines globally for several decades. The usage of newborn calf serum was transparently documented in the following publications since the last nine months," listing the publication.