New Delhi: While Covaxin Wednesday made it to the WHO emergency-use listing after a long wait, domestic approval of the vaccine for use among 2-18-year-olds remains stuck over three weeks after a technical committee recommended its approval.
Top sources in the Government of India say differences over the “package insert” — a summary of product characteristics, including information about who it is intended for and the contraindications — are the primary reason for the hold-up.
This is because, it is learnt, there are concerns about the use of the vaccine in children as young as two even though the clinical trial, which also looked at subjects that young, has been cleared by the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
“The recommendation of the SEC somehow got leaked, but you have to understand that for something like this there are considerations other than scientific ones too. We are looking at the age group of people that it can be administered to and we will take a call on that soon. We want to be very sure about the effects of the vaccine on children of various ages,” said a senior official of the ministry of health.
The fact that no other country in the world is currently administering the Covid vaccine to children as young as two, is said to be weighing on the decision-makers in the government, even though the expert committee was not deterred by it.
However, another senior official who is a key person in the vaccination programme denied that there are any scientific or age-related concerns. “There are no concerns about its use in children. A whole virion vaccine is safe for everybody. Moreover, it is one of the two mainstay vaccines for adults in India. The approval is not stuck over any scientific concerns. It is about the package insert. There has been some to and fro on this between the drug controller and the company. That is all. This is as per the recommendations of the SEC,” the official said.
ThePrint reached Bharat Biotech on WhatsApp about the hold-up but hadn’t received any response till the time of publishing this report.
Sources in the Covid working group of the National Technical Advisory Group on Immunisation (NTAGI) said they are yet to see the data of Covaxin use in children. “The ball is right now in the drug controller’s court. We have no idea about this,” an official said.
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Age 5 is the youngest currently being vaccinated
While Covaxin has been tested in children as young as two, no country is currently vaccinating kids that young. The youngest that are currently being vaccinated are five-year-olds in the United States, following a recommendation of the US Centers for Disease Control and Prevention (CDC) earlier this week to administer the Pfizer vaccine to 5-11-year-olds.
“Covid-19 cases in children can result in hospitalisations, deaths, MIS-C (inflammatory syndromes) and long-term complications, such as ‘long Covid’, in which symptoms can linger for months. The spread of the Delta variant resulted in a surge of Covid-19 cases in children throughout the summer,” the CDC had said while announcing the decision.
“During a 6-week period in late June to mid-August, Covid-19 hospitalisations among children and adolescents increased fivefold. Vaccination, along with other preventative measures, can protect children from Covid-19 using the safe and effective vaccines already recommended for use in adolescents and adults in the United States,” it added.
In most other countries, the youngest to get the vaccine are 12-year-olds.
The only vaccine currently under emergency-use authorisation in India that has been cleared for use in minors is ZyCoV-D of Zydus Cadila, but it can only be used in children who are 12 years or above.
(Edited by Poulomi Banerjee)
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