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 (RTI) shared an RTI response detailing the vaccine's development process, reported NewsBytes.
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."
A net decline of 47,946 cases has been recorded in the COVID-19 caseload in a span of 24 hours.
The 2,542 new fatalities include 1,458 from Maharashtra, 267 from Tamil Nadu, 166 from Kerala and 115 from Karnataka.
A total of 3,79,573 deaths have been reported so far in the country including 1,14,154 from Maharashtra, 33,148 from Karnataka, 30,068 from Tamil Nadu, 24,851 from Delhi, 21,914 from Uttar Pradesh, 17,049 from West Bengal, 15,650 from Punjab and 13,342 from Chhattisgarh.
The decision regarding enhancing interval between two doses of Covishield was based on scientific evidence and taken in a transparent manner, NTAGI Chair N K Arora said on Tuesday.
There was no dissenting voice among the members of the National Technical Advisory Group on Immunization (NTAGI ), he said, according to a tweet by the Union Health Ministry.
The government had on May 13 said it has accepted the COVID-19 Working Group's recommendation and extended the gap between the two doses of the Covishield vaccine from 6-8 weeks to 12-16 weeks.
"Based on the available real-life evidence, particularly from the UK, the COVID-19 Working Group agreed for increasing the dosing interval to 12-16 weeks between two doses of Covishield vaccine. No change in the interval of Covaxin vaccine doses was recommended," the ministry had said in a statement.
"The recommendation of the COVID-19 Working Group was accepted by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), headed by Dr V K Paul, Member (Health), Niti Aayog, in its meeting on May 12, 2021," the ministry said.
It has accepted this recommendation of the COVID-19 Working Group of extension of the gap between the first and second doses of Covishield to 12-16 weeks, the health ministry added.
Statement: '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."
Fact: '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.
Context: 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."
Fact: '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."
Other issues: 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.
Bharat Biotech: 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."
Fact: '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.
A single day rise of 62,224 new coronavirus infections were reported taking India's total tally of COVID-19 cases to 2,96,33,105, while the active cases were recorded below nine lakh after 70 days. The COVID-19 death toll climbed to 3,79,573 with 2,542 fresh fatalities, according to the Health Ministry on Wednesday. Congress leader Rahul Gandhi said India needs quick and complete vaccination and not the BJP's 'brand of lies and rhyming slogans' to cover up the vaccine shortage caused by the government's inaction.