Facing criticism for increasing the gap between two Covishield doses without allegedly taking all the experts into confidence and being questioned if the indigenously-developed Covaxin contained newborn calf serum, the Government on Wednesday defended itself on both the counts and termed the politicisation of the issue as “unfortunate”.
Union Health Minister Harsh Vardhan said the decision to increase the gap between two doses of Covishield has been taken in a transparent manner based on scientific data. “Decision to increase the gap between administering 2 doses of #COVISHIELD has been taken in a transparent manner based on scientific data. India has a robust mechanism to evaluate data. It’s unfortunate that such an important issue is being politicised!” he tweeted.
The National Technical Advisory Group on Immunization (NTAGI) chair N K Arora said, “The decision regarding enhancing interval between two doses of Covishield was based on scientific evidence and taken in a transparent manner.” “There was no dissenting voice among the NTAGI members,” he asserted.
Sharing details of the decision taken in this regard, the Health Ministry in a statement said that on May 13, it had approved extending the gap between the two doses of the Covishield vaccine from six to eight weeks to 12 to 16 weeks following a recommendation from the NTAGI.
“The 22nd meeting of Covid-19 Working Group of NTAGI was held on May 10. There, a proposal for a change in dose interval for Covishield, used under the National Vaccination Policy, was considered. Based on the real-life evidence, particularly from the United Kingdom, the Covid-19 Working Group agreed to increase the interval between two doses of Covishield Vaccine to 12 to 16 weeks, ‘’ the statement said.
“This recommendation was taken up for discussion at the meeting of the Standing Technical Sub-Committee (STSC) of NTAGI held on May 13 under the joint chairpersonship of the secretary of the Department of Biotechnology, the secretary of Department of Health Resources and the DG of the Indian Council of Medical Research,” it said.
“The STSC of NTAGI gave the following recommendation: ‘as per the Covid-19 Working Group recommendation, a dosing interval of minimum three months between two doses of Covishield vaccine was recommended’,” the statement said.
In both the meetings -- of the Covid-19 Working Group and of the STSC -- no dissent was given by any of the three members who have been quoted in the news report, namely Dr Mathew Varghese, Dr M D Gupte and Dr J P Muliyil, the statement said adding that Dr Varghese has denied talking to the reporter on the issue of his alleged dissent.
Regarding social media reports on Covaxin containing calf serum, it clarified that the indigenously developed jab does not contain newborn calf serum at all and that the calf serum is not an ingredient of the final vaccine product. Bharat Biotech, on its part also echoed similar points.
The Health ministry said that the newborn calf serum is used for preparation and growth of vero cells which are used in production of vaccines. This technique has been used for decades in Polio, Rabies, and Influenza vaccines.
“It is used for the growth of cells, but neither used in 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,” the Ministry said.
These cells are then washed with water, chemicals to make them free of the newborn calf serum. The vero cells are then infected with coronavirus for viral growth and in the process they are completely destroyed.
“In the final vaccine formulation no calf serum is used,” the Ministry said.
Bharat Biotech also clarified that the usage of new born calf serum was ‘transparently documented’ in several publications in the last nine months. The company had mentioned the same when it published animal trial study documents -which involved trials on hamsters and monkeys; in pre-clinical safety and immunogenicity study reports; in studies on neutralisation of the UK variant, the South Africa variant, the Delta variant among others.