Analysis on for use of Covaxin in kids: Govt
The national drugs regulator continues to analyse Covaxin data before granting approval for emergency use in children, Union health minister Mansukh Mandaviya said on Tuesday, as questions remain over why the clearance hasn’t come even though the subject expert committee of the central drugs standards control organisation recommended its use in children two weeks ago.
“This is a sensitive matter as it deals with children; therefore, the government has been clear, and taken a stand, from the start to not interfere in the decision-making on this technical topic. Let technical experts handle it. However, according to the information that I have, the technical committee has granted its approval on the matter, and the data is being further analysed. Decision on the vaccine’s use in children will be based on the outcome of that analysis. The analysis is not only based on local data but also on what’s the global trend as it deals with children,” said Mandaviya.
This is the first time the drugs controller general of India (DCGI), VG Somani, has taken this long to grant an approval following the SEC’s decision. The emergency use authorisation in all other six Covid vaccines that are approved for use in India, was granted in a day or two.
A senior official familiar with the development earlier said about the delay, “We will have to be extremely careful when talking about Covid-19 vaccination in children as even the developed countries that have begun vaccinating their children, are treading cautiously. The whole world is watching and we cannot afford to slip.”
On October 12, the expert group looking into vaccine approvals gave its clearance for the use of Covaxin in the 2-18 age group, raising the possibility that children could soon begin to receive doses since Bharat Biotech’s shot is already being administered in India.