From Bharat Biotech Covaxin, AstraZeneca/Oxford/ Serum Institute' Covishield and much more: EXPLAINED

Bharat Biotech's Covaxin is an exception as it is still in Phase-3 and yet to complete trial recruitment. No interim analysis of efficacy is available and pre-print Phase-1/2 data have only given details on immunogenicity and not efficacy of the vaccine. The emergency use approval, even as a back-up vaccine, is therefore highly unusual. Government authorities have announced that Serum's Covishield will remain the primary vaccine for the time being and Bharat Biotech's Covaxin will be in back-up, only to be used in case of a surge in case.

Serum Institute may need to offer better discounts to be able to sign high-quantity contracts with GOI, which are still in the pipeline, or be content with shorter-term contracts until alternatives emerge: Reuters

Bharat Biotech Covaxin: India’s drug regulator CDSCO has granted Emergency use approval to AstraZeneca/Oxford/ Serum Institute's Covishield and Bharat Biotech/ICMR’s Covaxin as first COVID-19 vaccines for India. While Covishield is backed by multinational Phase-3 data, Covaxin is still in Phase-3 in India. Jefferies believes that Covaxin’s hasty approval, even as a backup candidate, is driven primarily by GOI’s (Government of India) commercial considerations. At Covaxin's prices, GOI's budget for injecting the entire India would be USD 2.6 bn. Covaxin may be priced around Rs 350 according to reports although no rate has been announced by the company.

Early approval for Bharat Biotech’s Covaxin:

Drug regulators across the world have examined efficacy and safety data from Phase-3 of COVID-19 vaccine candidates before considering them for approval. Bharat Biotech's Covaxin is an exception as it is still in Phase-3 and yet to complete trial recruitment. No interim analysis of efficacy is available and pre-print Phase-1/2 data have only given details on immunogenicity and not efficacy of the vaccine. The emergency use approval, even as a back-up vaccine, is therefore highly unusual. Government authorities have announced that Serum's Covishield will remain the primary vaccine for the time being and Bharat Biotech's Covaxin will be in back-up, only to be used in case of a surge in case.

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Simultaneous approval may indicate attempt to create price competition:

Indian drug regulatory approval of two vaccines on the same date indicates GOI's attempts to put alternatives that can enable price competition. Serum Institute may need to offer better discounts to be able to sign high-quantity contracts with GOI, which are still in the pipeline, or be content with shorter-term contracts until alternatives emerge.

Best case quantities remain healthy, challenge would be in injecting 1.3 bn plus population quickly:

Government aims to run through the at-risk population (25% of population) by July 2021. However, Jefferies believes that it may take till the end of 2021 to achieve these numbers. The bottleneck is not in vaccine quantities. Best case estimates project that India may have enough Covid-19 vaccine doses to cover 78% of the population in 2021, without taking any doses from Moderna and Pfizer into consideration. Jefferies expects the private market to remain a small contributor to volumes given the high price of vaccines.

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