Expert panel clears use of Covaxin for ages 2-18
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 preprint 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.
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.