Good news on Covid-19 vaccination! India set to vaccinate 300 mn people; any problem? Serum, Bharat Biotech, Biological E, Hetero and others got it beat

In a historic drive, India is aiming to vaccinate 250-300 mn people by July-August 2021 and is in the process of identifying 10 mn frontline healthcare workers for the first phase of vaccination. India will have to vaccinate at least 60-70% of the overall population to achieve herd immunity, implying a 1.6 bn dose requirement (two doses per person) and has pre-purchased 1.6 bn doses from AstraZeneca-Oxford, Gamaleya and Novavax.

Is the humongous scale of the effort a problem in itself to carry out? 

No problem, says Kotak Institutional Equities. Multiple players including Serum, Bharat Biotech, Biological E, Hetero, Cadila Healthcare and potentially Aurobindo Pharma have enough manufacturing capacities, therefore, it does not see manufacturing as a challenge.

However, distribution across the breadth of the country remains a key constraint given the scale of vaccination. Kotak expects the government to utilize its existing cold chain network of UIP (29,000 points) spread across all states through which India administers 400 mn doses to 26 mn newborns and 30 mn pregnant women annually, with upgraded e-VIN app to be used for registration and monitoring. As Covid vaccination is likely to be a larger exercise compared to UIP, Kotak believes logistics support from private cold chains and airline carriers will also be required.

Covishield likely to be first large-scale approved vaccine in India:

In the past few weeks, multiple companies have reported vaccine efficacy data from their Phase III trials. Moderna and Pfizer/BioNTech have reported strong efficacy data and are likely to get US FDA Emergency Use Authorization (EUA) approval by mid-December. Pfizer has already received an approval by UK MHRA and has also applied for a EUA with India’s DGCI (based on international trial data and without any bridging trials).

However, mRNAbased vaccines will not be available in India on a large scale due to:

(1) the difficulty in storing these vaccines at very low temperatures

(2) higher pricing (US $20 per dose in the US versus US $3 for Covishield) even as Pfizer claims to be well prepared to handle logistical challenges and support effective vaccine transport, storage and temperature monitoring.

Conventional vaccines which require storage in 2-8 degree Celsius temperature are more relevant for India and we expect AstraZeneca/Oxford’s vaccine, manufactured by Serum Institute of India to get approval by December 2020/January 2021 despite divergent efficacy data in cohorts (90% in half+full dose 2,741 patient cohort in the UK, 62% in two full doses). Serum has applied for a EUA with DGCI based on four clinical trials conducted across the UK, Brazil and India. Among other candidates, Bharat Biotech’s Covaxin (applied for EUA with DGCI), Gamaleya’s Sputnik-V are already in Phase III and could be approved by April 2021 while Novavax and J&J are yet to start phase III trials in India.
India has pre-purchased maximum vaccine doses among all countries

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Assessment of purchasing agreements for Covid-19 vaccines reveals that high-income countries, as well as a few middle-income countries with high manufacturing capacity, have already purchased nearly 3.8 bn doses, with options for another 5 bn. As expected, mRNAbased vaccines are primarily secured by developed countries (US, EU, UK, Japan, Canada) while emerging nations have preferred to purchase vaccines based on conventional technologies given easier handling and storage.

Among countries with pre-purchase of vaccines, India ranks at the top with a pre-purchase of 1.6 bn doses. Among vaccine purchases made by India, while Oxford/AstraZeneca (500 mn dose) and Gamaleya’s Sputnik-V (100 mn dose) are on expected lines, India has also secured 1 bn doses from Novavax, which has a manufacturing agreement with Serum. Curiously, Novavax is yet to start its phase 3 trials in the US or India with the US trials getting delayed due to issues with the commercial manufacturing scale-up of its vaccine for the late stage study.