Vaccination of 12-14-year age group: No nod sought for Corbevax, says NTAGI

In the process of vaccine approvals, after the DCGI’s nod, the NTAGI deliberates on this and screens the ability of the vaccine to be part of the national vaccination drive at a three-level process.
A girl receives the Corbevax vaccine for COVID-19 at a health centre in New Delhi, India, Wednesday, March 16, 2022. (Photo | AP)
A girl receives the Corbevax vaccine for COVID-19 at a health centre in New Delhi, India, Wednesday, March 16, 2022. (Photo | AP)

BENGALURU: The Centre’s decision on administering vaccines for the 12-14-year age group has come as a surprise to members of National Technical Advisory Group on Immunisation (NTAGI).

While the Union Health Ministry, in a press release on March 14, said that the government had taken a call after “due deliberations with scientific bodies”, Dr Jayaprakash Muliyil, member of NTAGI, which is one of the important groups in the chain of granting approvals to vaccines, says he is “confused”. This issue is expected to be discussed in the next NTAGI meeting on March 23.

In the process of vaccine approvals, after the DCGI’s nod, the NTAGI deliberates on this and screens the ability of the vaccine to be part of the national vaccination drive at a three-level process.

Then, the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) takes a decision after which the Union Health Ministry approves it.

Speaking to TNIE, Dr Muliyil said, “The NTAGI has not recommended it. I don’t know which body has done it. Unless I have missed some point completely, this all seems very strange. You can say I am quite confused.”

He argues that children are naturally resistant to this virus and Omicron has created a sea of infections during the third wave. The vaccine that is now being given was based on the Wuhan strain of the virus. So why is that being given, he questioned.

On the risk versus benefit in administering Corbevax for 12-14-year-olds, experts feel that since a majority of children have already been infected, the risk in giving this vaccine may be minimal, but the benefit may also not be much.

Agreeing that a majority of children who were screened for the trials were already infected with Covid-19 and had good antibody levels, Dr Pradeep N, Principal Investigator of the Department of Paediatrics, Cheluvamba Hospital, which is one of the vaccine trial sites, said, “We screened nearly 300 children and found only 63 to be eligible. Many children tested for Covid antibodies, indicating past infection. We looked at zero antibody titers and selected 63 children for the trials.”

Dr Muliyil fears that when this vaccine is given to a large number of children, then there will be some untoward happenings.

No lack of info transfer, claims pharma firm chief

Amidst a controversy that the Corbevax vaccine has been launched for the paediatric population without sufficient approvals from the NTAGI, Mahima Datla, MD of Biological E, stated in Hyderabad that their most recent meeting with the body was on March 10, ruling out any such possibility of lack of information transfer.

“Our first point of sharing of data and information is the drug controller and, until they review the data, make suggestions whether it’s inputs to protocols or review of data, they are the first body to see it. Subsequent to approval from the DGCI, our next stop has been the NTAGI. There have also been instances where, upon their invitation, we have also shared data which is in the making without approval of DGCI,” said Mahima Data, speaking at the launch of the vaccine.

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