Covaxin gets emergency use approval for kids aged 2-18 years

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Public health experts says move can turn out to be a game changer and enable return to normalcy among the young population, reports Rachel Thomas

The Hyderabad-based pharma major Bharat Biotech’s Covaxin has got the emergency use approval for children in the age group of 2 to 18 years from the Drugs Controller General of India (DCGA).

The Subject Expert Committee on Covid-19 gave the approval for the emergency use in the children.

The expert panel said in a statement, “After detailed deliberation, the committee recommended for grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situation.”

Bharat Biotech had submitted the trial data of phase 2 and 3 of Covaxin on children in the beginning of this month to the apex body — DCGI at the start of this month. The vaccine will be administered in two doses with 20 days of interval.

However, Bharat Biotech needs to submit safety data with due analysis every 15 days for the first two months and monthly thereafter.

Remarkably, the global health body World Health Organisation has not granted the emergency use authorisation to Covaxin. The World Health Organisation said last week that it will carry out the risk and benefit assessment next week with experts and take a final decision on the much awaited EUL to Covid vaccine Covaxin.

The WHO said in the last meeting, “WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin”.

Meanwhile, India continues to show the declining trends in the daily trajectory of Covid caseloads. India on Tuesday reported 14,313 fresh Covid cases in the last 24 hours, lowest recorded cases in the 224 days. Total 181 deaths have also been reported in the same time span, pushing the death toll to 4,50,963, the Union Health Ministry said.

The Active Caseload is presently 2,14,900, which is the lowest in 212 days. The active Covid cases presently constitute 0.63 per cent of the country’s total positive cases.

Experts welcome move

Covid vaccinations for children and adolescents can turn out to be a game changer and enable return to normalcy among the young population, said public health experts.

“The news is very encouraging. I am very much sure that this initiative will be a game changer to protect our children and adolescents,” Dr Sujeet Ranjan, Head Nutrition, Tata Trusts said.

“In India, best efforts have been put into protecting children after the warning from the experts and the dangerous second wave. With schools reopening in many states for certain age groups, the vaccine for children 2-18 years will help them return to normal,” he added.

In a statement, Bharat Biotech said it had submitted the trial data of phase 2 and 3 of Covaxin on children to the Central Drugs Standard Control Organisation (CDSCO) at the beginning of this month.

While data on these trials has not been made public yet, tests were conducted on more than 1,000 children across the country. “The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and have provided their positive recommendations,” read the statement from the company.

The expert panel noted that the trial on kids showed similar efficacy rates as that on adults. However, Bharat Biotech needs to submit safety data with due analysis every 15 days for the first two months and monthly thereafter.

“After detailed deliberation, the committee recommended for grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations,” the expert panel said in a statement.

Dr Rahul Nagpal, Director of Paediatric and Neonatology at Fortis Hospital, Vasant Kunj, said: “The approval to give Covid-19 vaccine to children is very good news for children as well as their parents. This approval will also open the path for children to come back to normal life completely and schools will be functional. With this approval now we can also get rid of this pandemic.”

However, some experts have also raised concerns.

“While it is reassuring to know that the vaccine has worked well in children, rollout in children must be scheduled only when we are confident that adults who are at greater risk of more severe illness have acquired immunity in large numbers,” Public Health Foundation of India President K. Srinath Reddy said.

“Children who are immunocompromised may be given early jabs. Only in 2022, we will be able to judge the need for, and benefits of, mass vaccination in children. Evidence will be available by then, from different countries,” he added.

“If the vaccine safety data is strong enough and we immunise them, it will have a big impact in reducing the transmission of Covid. This will be a major step as school, coaching centres and sport centres are gradually opening.” Dr. Akshay Budhraja, Senior Consultant, Pulmonology, Aakash Healthcare, Dwarka said.

Meanwhile, the World Health Organisation is yet to grant the emergency use authorisation to Covaxin. The global health body said last week that it will carry out the risk and benefit assessment next week with experts and take a final decision on the much awaited EUL to Covid vaccine Covaxin.

Bharat Biotech added that it is awaiting further regulatory approval from the CDSCO “prior to product launch and market availability of Covaxin for children”.

Once approved, Covaxin will become the second vaccine cleared for use on kids in India. In August Zydus Cadila’s three-dose DNA jab was the first to get approval to be used on adults and children over 12.

Serum Institute’s Novavax — for children between seven and 11 years — and Biological E’s Corbevax — cleared to conduct advanced trials on children above five — are the other potential vaccines for kids.

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