New Delhi: The government’s expert panel on immunisation is likely to review the data of Serum Institute of India’s (SII’s) anti-Covid vaccine Covovax by this week to decide whether it can be included in the national Covid vaccination programme, according to people familiar with the development.
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Members of the National Technical Advisory Group on Immunisation (NTAGI) will look into the data presented before the Drugs Controller General of India (DCGI) to put forth their recommendations. The move is significant as the government considers recommendations by NTAGI to make policy decisions regarding any expansions in the national Covid vaccination programme.
“The members of the working group on Covid are most likely to meet towards the end of this week. It is too early to decide whether the vaccine will be introduced under the programme or not, but this review is the first step in that direction if it were to happen,” said a senior government official aware of the matter, on condition of anonymity.
According to people familiar with the development, Covovax could initially be introduced for use among children aged 12 and above under the national Covid immunisation programme as currently only Bharat Biotech’s Covaxin and Biological E’s Corbevax are being administered in India under the programme. While children in the 15-18 years age group are being administered Covaxin, children aged 12 to 15 years are being administered the Corbevax vaccine.
{{/usCountry}}According to people familiar with the development, Covovax could initially be introduced for use among children aged 12 and above under the national Covid immunisation programme as currently only Bharat Biotech’s Covaxin and Biological E’s Corbevax are being administered in India under the programme. While children in the 15-18 years age group are being administered Covaxin, children aged 12 to 15 years are being administered the Corbevax vaccine.
{{/usCountry}}Covovax is the second anti-Covid vaccine manufactured by SII after Covishield, and has been developed by US-based Novavax Inc. On December 28 last year, the DCGI had approved Covovax for emergency use in adults, and had approved the vaccine for emergency use in those aged 12 and above, making it the fourth Covid vaccine approved for emergency use in children in this age group.
“…The Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) for Novavax’ protein-based COVID-19 vaccine for adolescents aged ≥12 to <18 years in India...,” Novavax Inc had announced.
In August 2020, Novavax had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its Covid-19 vaccine candidate, in low and middle-income countries.
The vaccine is a protein subunit vaccine that delivers a full spike of the Sars-Cov-2 to train immunity. It is the only vaccine apart from mRNA platform doses which demonstrate an efficacy of more than 90% against the original Sars-Cov-2 virus.
A Phase 2/3, observer-blinded, randomized, controlled study in a total of 460 Indian adolescents aged 12 to 18 years was conducted to evaluate the safety and immunogenicity of Covovax. The study demonstrated that Covovax was well-tolerated with a reassuring safety profile. Furthermore, the data indicated that Covovax is immunogenic in adolescents aged 12 to 18 years.