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Exclusive: Centre Approved Corbevax for 12-14 Year Olds Without NTAGI Clearance

Exclusive: Centre Approved Corbevax for 12-14 Year Olds Without NTAGI Clearance

Healthcare workers administer COVID-19 vaccines to recipients aged 15-18 years, Mumbai, January 31, 2022. Photo: PTI

  • The Centre has announced that children aged 12-14 years will become eligible for COVID-19 vaccination from March 16.
  • A health ministry press release on March 14 said the government had taken the call after “due deliberations with scientific bodies” – but didn’t specify which bodies.
  • The Wire Science has learnt that the National Technical Advisory Group on Immunisation wasn’t one of these bodies.
  • The NTAGI has a three-level approval process that includes the inputs of topical experts, and its approval is required before the NEGVAC’s clearance.
  • The Centre’s decision to skip the NTAGI’s approval for Corbevax deprives the vetting process of three levels of checks, including by subject experts.

New Delhi: The Centre announced on March 14 that children aged 12-14 years will become eligible for COVID-19 vaccination from March 16. A press release issued by the Union health ministry on March 14 said the government had taken the call after “due deliberations with scientific bodies”.

However, the government did not specify which were those “bodies”, and the reason for the ambiguity in the health ministry release wasn’t clear.

But The Wire Science has since learnt that the National Technical Advisory Group on Immunisation (NTAGI) wasn’t one of these bodies. The NTAGI is one of the bodies whose clearance is required before a vaccine, approved by the drug regulator, can become part of the national COVID-19 vaccination drive.

The Centre’s approval for Corbevax is the first to defy this step of the vaccine clearance process, at least according to the public record.

The NTAGI is one of the most important groups in the chain of granting approval to vaccines. After a recommendation from the Drugs Controller General of India (DCGI), the NTAGI, constituted by the Centre itself, deliberates on the vaccine’s ability to participate in the national vaccination drive.

The body comprises government officials as well as independent subject experts. After the NTAGI’s approval, the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) has to make a decision. The Union health ministry finally approves a  COVID-19 vaccine only after the NEGVAC’s decision.

“NTAGI has not recommended it. I don’t know which other body has done it,” Jayaprakash Muliyil, a member of NTAGI, told The Wire Science on March 14 evening. Muliyil is also a former professor of community medicine at the Christian Medical College, Vellore.

Since the NTAGI hasn’t given its go-ahead for Corbevax, it is not clear if NEGVAC has done so either, or if it has, on what basis.

Another NTAGI member confirmed Muliyil’s statement. “It was only the working group of the NTAGI that had discussed Corbevax,” the member said. (They requested anonymity as they weren’t authorised to talk to the press.)

The NTAGI has a three-tier decision-making system. The working group of the body is the first level. According to NTAGI’s ‘Code of Practice’, this group deliberates on the evidence submitted by the vaccine’s manufacturer from the shot’s clinical trials. It also reviews the existing scientific literature on the subject. Then it builds its case, to be presented to the NTAGI’s Standing Technical Sub-Committee (STSC).

The STSC is the second level. “The STSC will meet to analyse the evidence that is synthesised and presented by the working group and any external subject matter experts, whose contribution the working group considers essential,” according to the code.

STSC members once again review the evidence, discuss the recommendations of the working group and come to a conclusion. They then pass this on to the main group of NTAGI, which makes NTAGI’s final decision on the vaccine.

Both members of the NTAGI said neither STSC nor the main group had approved Corbevax for those aged 12-14 years. “Yes, we have seen the data. But we didn’t give any final submission,” Muliyil said. He added, “There was no post-omicron data” for Corbevax.

They also confirmed that STSC and the main NTAGI group have only seen the safety and immunogenicity data for Corbevax – and not the efficacy data.

Immunogenicity measures a vaccine’s ability to induce the production of antibodies. Efficacy is a measure of how robust the immune response (which includes the antibodies) is. Immunogenicity trials are almost always smaller than efficacy trials, and as such their data can’t be extrapolated to estimate the efficacy.

“The safety data was fine but the total number of subjects was small,” Muliyil said.

According to the Corbevax trial for children registered on the Clinical Trial Registry of India (CTRI), 624 children volunteered for the trial.

Currently, adolescents aged 15-18 years are eligible to receive Covaxin, the COVID-19 vaccine made by Bharat Biotech. According to the CTRI, 525 children enrolled in the clinical trial for Covaxin. Like Corbevax, Covaxin had not been tested against the omicron variant when the government approved its use among children in December 2021.

“But if you are approving a vaccine now, that too for children, why shouldn’t you consider a scenario which is post-omicron specific?” Muliyil asked.

India experienced its third COVID-19 wave, driven by the omicron variant, from December 2021 to January 2022.

All other variants of SARS-CoV-2 have by and large faded away; the omicron variant remains the dominant strain in populations worldwide, including in India. Thus, Muliyil added, the need for a vaccine that has been tested against the omicron variant is important.

“We don’t have any evidence that [Corbevax] will really suppress” a new variant, he told The Wire Science.

The Wire Science had reported on March 2, 2022, that the Centre didn’t wait for NTAGI’s nod before it placed an order for 5 crore Corbevax doses from its manufacturer in India, Biological E. The state governments of West Bengal and Tamil Nadu have also received at least 4 lakh doses each, to vaccinate children aged 12-18 years. Rajasthan has also received 30 lakh doses for those aged 12-14 years.

The Wire Science also found that there is no data vis-à-vis Corbevax in the public domain even for use among adults.

In response to our report, the National COVID-19 Taskforce chairman Vinod K. Paul said in a press conference on March 3 only that the country should “trust” the DCGI’s decisions.

Paul had also said that the NTAGI would take an appropriate decision at the ‘right’ time regarding the use of Corbevax. He added that a scientific paper regarding the Corbevax trial should be published soon and that it would be in the public domain. He refused to share any data himself, however.

The Wire Science asked Biological E, on March 14, about such a paper containing clinical trial data. Company spokesperson Vijay K. Amruth Raj only said, however, that “The work is still under progress”.

Questions on Corbevax for children

Some experts have also raised doubts about the very need for vaccines for children – Muliyil among them. He said a large chunk of the population, including children, have natural immunity thanks to the rapid spread of the delta and omicron variants. “Omicron, especially, was a very, very strong immune-potentiator[footnote]Meaning it enhanced the immune response[/footnote]. This context can’t be ignored while making decisions now,” he told The Wire Science.

The Indian Academy of Paediatrics (IAP) has, however, been demanding that the country’s children be vaccinated. While children make up a very small fraction of COVID-19 cases in the country, the number of paediatric infections did increase when more transmissible variants, like the delta, surfaced, the IAP had said in December.

Nonetheless, experts at large remain divided on the issue. One group has said that even if children are infected, they get only mild disease, so they should only be vaccinated after a risk-benefit analysis. Another group, including the IAP, has maintained that all children should be vaccinated, even if it admits that only a few get serious COVID-19.

In addition, there have been news reports of some parents around the country who have insisted on vaccinating their wards to protect them against future surges.

Muliyil said he had no objection if a certain section of parents wanted to have their children vaccinated, if vaccines are available. “But the problem arises when, for example, students are not allowed to sit in examinations without showing their vaccination status.”

He warned that expanding the vaccination drive to include younger and younger children in haste, especially without creating adequate safeguards for those who don’t want it, could be unethical and dangerous.

At this point, irrespective of which group prevails, the Centre’s decision to skip over the NTAGI’s approval for Corbevax for 12-14 year-olds has effectively deprived the vetting process of three levels of checks, including the opinions of subject experts.

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