Expert panel clears use of Covaxin for ages 2-18

The approval by the Subject Expert Committee (SEC) will need to be accepted by the Drugs Controller General of India – which is expected within days – and has to be followed by a formal inclusion in the government’s coronavirus immunisation campaign.
Bharat Biotech, which makes Covaxin, confirmed the SEC approval.(AP)
Bharat Biotech, which makes Covaxin, confirmed the SEC approval.(AP)
Updated on Oct 13, 2021 05:32 AM IST
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ByRhythma Kaul, Hindustan Times, New Delhi

The expert group looking at vaccine approvals has recommended the use of Covaxin in the 2-18 age group, officials aware of the matter said on Tuesday, raising the possibility that the first of children could soon begin to receive doses since the shot is already being administered in India.

The approval by the Subject Expert Committee (SEC) will need to be accepted by the Drugs Controller General of India – which is expected within days – and has to be followed by a formal inclusion in the government’s coronavirus immunisation campaign.

“As per the data that the company submitted, the vaccine has been found to be safe and efficacious in children. The experts were of the opinion that it should be allowed for use in children,” said a senior official in the know of things, asking not to be named.

However, even as India discusses delivering the dose to children, the company’s phase III clinical trial data is yet to be peer-reviewed. It has released the efficacy data only in press statements and in papers uploaded on pre-print servers.The recognition of Covaxin as a valid vaccine by other countries at large has also been under a cloud — the World Health Organization is likely to take a decision this week on whether to add the shot to its list of approved vaccines.

These factors, experts say, could trigger hesitancy among parents — especially since the vaccine’s initial approval in January was rushed through, although data from the press release and the papers uploaded on pre-print servers suggest the vaccine has a high 77.8% efficacy against symptomatic Covid, 93.4% against severe Covid, and 65.2% against the infection caused by the Delta variant.

In addition to ZyCoV-D and Covaxin, two more vaccines are being tested in children.
In addition to ZyCoV-D and Covaxin, two more vaccines are being tested in children.

Much will also depend on what data the company and the regulator choose to release over the next few days.

“…As a paediatrician, I would go slow; I will see how the data comes in, or when the vaccine is actually is being given to children at different centres in various parts of the country. We need to see how the response is...,” said Dr Manish Mannan, head of paediatrics and neonatology, Paras Hopsital, Gurugram, in a statement.

This is the first vaccine to have received clearance for children under the age of 12. Zydus Cadila’s ZyCoV-D, which was tested in volunteers aged 12 and above, received an approval last month. The product is yet to be included in the vaccination campaign.

A second official, from the health ministry, said the decision on when to begin administering Covaxin to children will depend on government the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) and the National Technical Advisory Group on Immunisation (NTAGI).

“Whether it will be introduced in the national Covid-19 immunisation programme, and if yes, then how soon, will be for the expert panels on immunisation to decide,” this person said.

Bharat Biotech, which makes Covaxin, confirmed the SEC approval. “Bharat Biotech has submitted data from clinical trials in the 2-18 years age group for COVAXIN (BBV152) to CDSCO. The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and have provided their positive recommendations. This represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thank the DCGI, Subject Experts Committee, and CDSCO for their expedited review process. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of COVAXIN for Children,” the company said in a statement issued on Tuesday.

According to experts involved in the clinical trials, the safety and efficacy of Covaxin in the paediatric age group has been found to be almost similar to that in adults and the level of antibodies that developed in the volunteers was similar to what has been recorded in adults.

This data acts as a comparator, and suggests that the efficacy in children is likely to be similar to the 77.8% efficacy recorded in the adult clinical trials.

“Paediatric vaccine is the same as the adult vaccine in terms of dosage, safety, immunogenicity and efficacy that has already been established in the adult population. It is equally safe and effective in children and the need for conducting a trial among paediatric age group was to generate evidence for it,” said Dr Sanjay Rai, professor, department of community medicine, All India Institute of Medical Sciences (AIIMS), Delhi, who is also the principal investigator for the Covaxin trials at the AIIMS site.

Bharat Biotech completed phase 2/3 clinical trials in children in September and submitted the data to the DCGI in October.

Experts aware of the matter said the roll-out for children will likely be in stages, with the entire population in the 2-18 age group unlikely to be covered at one go. “Members of expert committees have suggested the idea of introducing it in a phased manner for children, giving priority to those who suffer from specified comorbidities,” said a person aware of the discussions, while adding that it will be done in “the same way as it was done for adults”.

Government experts are working on a list of comorbidities that could determine which children are eligible for a vaccine first.

“They will have to do it in a phased manner as if you look at the numbers there should be about 400 million children, and 1-2% of them likely to be at higher risk because of their medical condition and the kind of treatment they would be taking such as chemo, transplant medication, etc. It will be a huge challenge logistically; therefore, doing it in phases makes sense,” said Dr Anupam Sibal, senior paediatrician and group medical director, Apollo Hospitals.

When introduced in the programme, the vaccination is likely to happen through pre-filled syringes to have better dose accuracy, the first person quoted above said.

According to the conditions under which use in paediatric population has been approved, the firm should continue the study as per the approved clinical trial protocol and provide safety data, including the data on AEFI and AESI, with due analysis, every 15 days for the first two months. After that, this data needs to be submitted on a monthly basis.

India has so far fully vaccinated around 29% of about 944 million eligible adults, as per government data, which includes administration of more than 110 million doses of Covaxin. Covishield, the India-made version of the Oxford-AstraZeneca vaccine, accounts for over 840 million doses that have been delivered.Another 44% has been partly vaccinated.

Several countries have been working to authorise vaccines for children, with the United States clearing Pfizer’s shot for children aged 12 and above. According to Oxford University’s Our World in Data project, over 50 countries have allowed children of some age groups to begin receiving doses.

In addition to ZyCoV-D and Covaxin, two more vaccines are being tested in children. The Drugs Controller General of India on September 1 granted permission to Hyderabad-based Biological E Limited to conduct phase 2/3 clinical trial of its made in India vaccine, Corbevax, on children and adolescents aged between 5 and 18 years with certain conditions.

In July, Serum Institute of India (SII) was given permission to conduct phase 2/3 trials of Covovax (the dose developed by Novavax) on children aged 2 to 18 years.

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Tuesday, December 07, 2021