With about 40 crore children to vaccinate, Bharat Biotech has a mountain to climb

The company has said that this is one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group - A file image.

Bharat Biotech is, arguably, in the midst of the biggest challenge of its quarter-of-a-century existence.

With the Subject Expert Committee (SEC) recommending emergency use authorisation (EUA) to Bharat Biotech's Covaxin for children aged between 2-18 and submitting its proposals to the Drugs Controller General of India (DCGI) for final approval, the ball is truly in the Hyderabad-based company’s court.

Bharat Biotech had last week submitted Phase  2/3 of children's trials to the DCGI for its verification.

In a statement, the company said that this represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group. "Bharat Biotech sincerely thanks the DCGI, Subject Experts Committee, and the Central Drugs Standard Control Organisation (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," it said, with justifiable pride.

The challenges, however, are gargantuan, to say the least. Close to 40 crore children fall in this age group – roughly 30 percent of the total Indian population - and it seems highly unlikely, even impossible, that one company would be able to meet the demand.

Covaxin is the second COVID-19 vaccine to get approved for children in India. DGCI had, in August this year, approved Zydus Cadila’s ZyKoV-D for children aged 12 and above, as well as adults. However, their rollout has not yet begun.

Even more important, students attending schools after a long COVID lay off need to take care, as has been recommended by an expert committee of educators from public and private schools, health care professionals and parents from across the country, who have come together to present a range of steps to protect the health of children.

Moneycontrol talked to five leading experts to figure out the way ahead, the significance of broad basing vaccinations to cover roughly a quarter of the population, after approximately 100 crore of the country’s population has been vaccinated two times so far, according to the Union Ministry of Health.

Let’s look at it like this. There are about 40 crore children who will be vaccinated in this 2-18 age group. While Covaxin certainly has global data, I don’t know how much information they have on children. There is certainly going to be a shortage of vaccine. So I would suggest a division of labour. Let Zydus, which has about a crore of doses vaccinate children above the ages of 12 plus, as they have submitted to the regulator, while Covaxin looks at the rest.

It is also important to remember that children, who have been hit by COVID in the last couple of years, have mild fever and symptoms. The way I look at it, once the virus subsides even further, it is only the educated and upper class students, who will opt in for the vaccination. The poorer students, which are in a majority, may just back out.

The whole concept seems to me to be on unsteady legs. While theoretically, vaccine for children, which is basically a chilled vaccine, has a long history in India, as in the case of polio among other inoculations, whether Bharat Biotech’s Covaxin should be delivered to children, I cannot say because there is no data yet out in the public domain. The data submitted by Bharat Biotech to DGCI, is not public as yet. In addition, the sample size being used appears to be quite limited, from what I have seen.

It is not clear what or how many doses the company is going to give; it does not appear to be scientific, in my view. There is no public data being shared on that. It is also not clear whether Bharat Biotech can even produce so much vaccine to give to children. Clearly, apart from the medicinal aspect, there is also the political aspect, and I cannot comment on that.

It is a very good move and we at the AHPI have come out with a set of recommendations for schools before children arrived on the campuses last month. When most of the population has been vaccinated, there is no reason why children should be left behind.

Our proposals were the following. One, the parents should sensitise and teach children to follow hygienic practices. A school task force/Committee for COVID Safety should recommend safety protocols and review safety measures. COVID facility requirements should be placed in classrooms and other areas on the school premises. All teachers, administrators, staff and other school employees, including bus drivers, should be fully vaccinated and appropriately trained.

Schools should openly communicate with parents about the safety protocols and preventive measures that need to be put in place in the schools and receive the parents’ consent before their children attend classes.

Detailed recommendations for day today management have been developed for various aspects of school life, including campus management, toilet and washroom usage guidelines, specific safety protocols for playgrounds, laboratories, common areas, cafeterias, provision of mid-day meals and transport facilities.

I believe it is a very good move. Given India’s demography, a young country, you could not possibly have left out roughly 30 percent of its population between the ages of 2-18. That is the only way to contain the virus, across the board. Peer review is important. Now that data is available, there are two ways to make that information public. One is for regulatory authorities to certify its veracity and two, Bharat Biotech can present its findings in a specialised medical journal. This process does take some time and cannot be done in a hurry. India has a long history of vaccinating children, so I don’t see any problem there.

As to the question why only Covaxin and not Covishield should be considered for children, it is only a question of time. After all, India is a huge market and no company would like to let go of an opportunity to sell vaccines to about one-third of that market.

Vaccinating children was a natural corollary after the inoculation of adults. It was a mere formality. Now that a large section of the 15-plus age group had been covered, it was only natural that the youngest sections of the population be vaccinated. It was found safe by the concerned authorities, adequate trials had been conducted and there is every reason for such a plan to be put in place.

To be sure, it is a big challenge for Bharat Biotech. The ball is in their court now. It is for them to demonstrate how much they can produce and how they will be able to meet their targets. I should think that with their new plants in Bengaluru and Maharashtra, they would have increased their capacities.

I am also sure that as soon as Covishield has conducted their children's trial, they too would be in the picture, the Serum Institute of India being one of the largest vaccine manufacturers in the world.