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Following the news that the Subject Expert Committee (SEC) provided a positive recommendation to the Drug Controller General of India (DCGI) for the use of Bharat Biotech’s Covaxin in 2-18 years age group for COVID-19;
Prashant Khadayate, Director of Life Sciences Consulting and Research at GlobalData, a leading data and analytics company, offers his view:
“Covaxin may become the second indigenous vaccine to get approval below 18 years for COVID-19; however, it will be the only vaccine to cover the 2-18 years age group in India. Zydus Cadila’s ZyCov-D is the first vaccine in India to get approval for the 12-18 years age group and was approved in India on 20 August 2021. However, it is not yet part of the COVID-19 vaccination drive as price negotiations with the Indian government are still ongoing.
“Covaxin’s PII/PIII trial was conducted in India by segregating children into age groups ≤18 – >12, ≤12 ->6, ≤ 6 – >2 years and 28 days between the first and second doses. Unfortunately, Covaxin’s PII/PIII trial results are not yet available publicly available.
“Following approval, Covaxin will compete with ZyCov-D for; however, compared to ZyCov-D – Covaxin already has a well-established supply chain and requires one fewer dose than ZyCov-D. Moreover, the pricing of Covaxin would be less compared to ZyCov-D, especially for private hospitals. In addition, the majority of the vaccination drive in India is dominated by government hospitals.
“Bharat Biotech expects to supply 55 million doses of Covaxin per month from October from the existing 35 million doses. In contrast, Zydus Cadila is expected to produce 10 million doses of ZyCov-D per month.
“According to GlobalData’s Pharma Intelligence Center, India is ranked second globally after China in terms of the total number of COVID-19 vaccine doses administered at over 954 million doses as of 11 October 2021. Covaxin is the second-most popular vaccine after Covishield as part of the COVID-19 vaccination drive in India. The country has administered over 110 million doses of Covaxin.
“In the near future, the overall competition in the below 18 years age group will intensify with potential approvals. However, the success of the new vaccines will be dependent on meeting the demand in a swift manner.”