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Friday, October 22, 2021

Panel approval is in, Covaxin for children is one step away

Bharat Biotech is also expecting a decision soon on its separate application for EUA of Covaxin in adults from WHO.

Written by Kaunain Sheriff M | New Delhi |
Updated: October 13, 2021 2:21:46 am
CovaxinThe development is significant as India is just one step away from a Covid-19 vaccine being formally approved for children above the age of 2 years. (Express photo: Deepak Joshi)

THE DECKS are being cleared for children to be included in India’s Covid vaccination drive with the Government’s Subject Expert Committee (SEC) Tuesday recommending the grant of Emergency Use Authorisation (EUA) for Bharat Biotech’s Covaxin in the age group of 2-18 years.

The SEC’s recommendation to the Drug Controller General of India (DGCI) means that India is just one step away from formally clearing the vaccine for children. Sources told The Indian Express that the DGCI is expected to approve the SEC’s recommendation soon, potentially bringing an additional 25 crore beneficiaries under the vaccination umbrella.

Bharat Biotech is also expecting a decision soon on its separate application for EUA of Covaxin in adults from WHO.

Globally, the SEC’s green signal is the first by an expert panel of a national regulator for the 2-18 age group. On October 26, the US expert panel is expected to discuss a request from pharma giant Pfizer for EUA of its Covid vaccine in the age group of 5-12 years in that country.

So far, India has approved Zydus Cadila’s vaccine for children aged above 12 years. Pfizer’s double dose has been recommended for 12 years and above in the US, and a single dose for the same age level in the UK. Moderna’s vaccine has also been approved by the UK regulator for those above 12 years old.

Welcoming the SEC clearance, Hyderabad-based Bharat Biotech said: “This represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group… We now await further regulatory approvals from the CDSCO (Central Drugs Standard Control Organisation) prior to product launch and market availability of Covaxin for children.”

The SEC decision will have significant public health implications, with schools and colleges reopening in a phased manner across the country. Once the DGCI shows the green flag, the next key decision would be to identify priority categories among those in the 2-18 age group, such as those with comorbidities.

Explained

Meanwhile, wait for WHO on

Over 11.08 crore cumulative doses of Covaxin have been administered across India. Yet, Bharat Biotech is yet to receive an EUA from the WHO, which would enable beneficiaries to travel to foreign countries without stringent restrictions.

“Since this is happening for the first time, there is a possibility that certain conditions would be imposed by the drug regulator when it grants the EUA. There could be a mandate that the vaccination should take place only in health facilities or under a certain level of supervision,” sources said.

Once the formal EUA approval is granted, the high-powered National Expert Group on Vaccine Administration for Covid-19 (NEGVEC) “will take a final call on which category of children will be prioritised for vaccination”, sources said.

The Indian Express reported on October 4 that the final call on Covid vaccination of children, including guidelines on the categories to be prioritised as well as the timeline, would be taken in the first half of this month.

India has administered a cumulative 96.33 crore doses of Covid vaccines across the country, and is expected to touch the landmark of 100 crore in the next few days. According to official data, 73 per cent of the estimated adult population has received the first dose while 29 per cent is fully vaccinated.

According to the data, over 11.08 crore cumulative doses of Covaxin have been administered so far across the country. However, Bharat Biotech is yet to receive an EUA from the WHO, which would enable Covaxin beneficiaries to travel abroad without strict restrictions.

Sources in the company said they expect a final decision by WHO “in the next few days”. They said the world body’s Strategic Advisory Group (SAGE) has completed its evaluation, and that another expert group will take it up in a meeting soon to examine technical aspects.

The SAGE on immunization held a meeting from October 4-7, and reviewed Covaxin on October 5. During the review, Bharat Biotech made a presentation for about 30 minutes on safety and efficacy data from clinical trial results as well as after marketing. In its highlights from the meeting, SAGE stated that “a policy recommendation will be issued when the vaccine is Emergency Use listed by WHO”.

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