DCGI yet to approve Covaxin’s emergency use in children

For the vaccine to be included formally in the government’s coronavirus immunisation campaign for children, DCGI’s approval is mandatory.
The DCGI is yet to approve Bharat Biotech’s coronavirus vaccine Covaxin for emergency use in children despite a recommendation from the Subject Expert Committee (SEC) earlier in the week. (PTI)
The DCGI is yet to approve Bharat Biotech’s coronavirus vaccine Covaxin for emergency use in children despite a recommendation from the Subject Expert Committee (SEC) earlier in the week. (PTI)
Updated on Oct 16, 2021 04:42 AM IST
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ByRhythma Kaul, Hindustan Times, New Delhi

India’s apex drugs regulator is yet to approve Bharat Biotech’s coronavirus vaccine Covaxin for emergency use in children despite a recommendation from the Subject Expert Committee (SEC) earlier in the week, people familiar with the matter said on Friday, attributing the delay to additional technical opinion that is being sought.

The Drugs Controller General of India (DCGI) gives the requisite approval (including emergency approval) before a pharmaceutical product can be used in India and in the case of Covid-19 vaccines, the authority has typically taken a day or two at most to clear an SEC recommendation.

“The drugs controller general of India (DCGI) is taking more technical opinion on vaccinating children even though the expert panel has recommended its use,” said a senior official in the Union ministry of health and family welfare, asking not to be named.

The SEC is part of the central drugs standard control organisation (CDSCO).

“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,” said the official cited above.

On Tuesday, 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.

For the vaccine to be included formally in the government’s coronavirus immunisation campaign for children, DCGI’s approval is mandatory.

This is the second vaccine to have received clearance in this age group. The first was Zydus Healthcare’s ZyCoV-D, which was tested in volunteers aged 12 and above and is likely to be rolled out for recipients no younger than that.

The product is yet to be included in the vaccination campaign. Officials last week said health workers are at present being trained to use a special needle-free applicator that is used to deliver the vaccine.

An official from the health ministry said that 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).

Experts, however, have been saying that there is no immediate need to vaccinate all children as it has been proven that severe disease in children is not common.

“The focus should be on vaccinating our adult population that is at high risk; children, especially the healthy ones, should not be our immediate priority. Eventually we will have to vaccine everyone but there is no pressing need to vaccinate all children,” said a senior public health expert, requesting anonymity.

WHO chief scientist, Dr Soumya Swaminathan, has similar views on booster doses.

“There is more than enough evidence now that the currently used vaccines are highly effective in preventing serious illness and death due to #COVID19. We need to focus on expanding primary vaccination coverage worldwide, before boosters!,” Swaminathan tweeted on Friday.

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Thursday, December 09, 2021