The number of COVID-19 cases in India currently stands at 8.6 million, but the growth in new cases has considerably slowed down to 0.6 per cent 5-day CDGR.
The average number of daily cases in the trailing week has dropped to 46,000 (vs 92,000 at peak), the report said. The recovery rate has also increased to 93 per cent, and the total number of active cases is less than half of the peak. These metrics point to a moderation in pandemic severity.
However, this may not reflect the actual underlying disease burden given that the latest nationwide sero-prevalence study, conducted between August 17 and September 22 in 70 districts across 21 states, found that 6.6 per cent of the total participants were exposed to SARSCoV-2, while reported cases then were 0.3 per cent (of total population). This indicates that the actual infections could be 25 times the reported cases.
However, from India's perspective, the success of mRNA candidates would have little impact since they have more stringent cold chain requirements, with the Pfizer candidate requiring cold chain to operate at as low as -70-degree Celsius.
The Serum Institute of India has mentioned that it has already been producing about 40-50 million doses per month and, therefore, it has stockpiled initial inventory for Oxford/AstraZeneca vaccine.
Hence, this should be the first vaccine available in 1Q CY21 in India (unless Indian government provides an Emergency Use Authorisation to any other company). Thereafter, 2QCY21 onwards, multiple plants are expected to come online and Serum's manufacturing capacity could also get augmented to 100 million doses per month by around June 2021.
In terms of availability, Serum said that Oxford/AstraZeneca's ChAdOx1 nCoV-19 vaccine candidate, named Covishield in India, can be provided regulatory go-ahead as early as December 2020 provided the trial results are successful. Serum is currently conducting Phase II/III trials of Covishield among 1,600 participants across 17 sites in India, aged 18 to 55.
Biological E is working on capacity to manufacture 1. 4 billion vaccine doses annually, comprising 400 million doses for J&J and 1 billion doses for its vaccine developed with US-based Baylor College of Medicine (BCM).
In addition, Biological E has signed a licensing agreement with BCM under which the latter would facilitate technology transfer for recombinant protein-based COVID-19 vaccine.
Biological E would undertake further development, conduct clinical trials and manufacture ~1 billion doses annually. In order to augment its capacity, it had recently acquired Akorn India's facility in Paonta Sahib in Himachal Pradesh, which has capacity to produce 135 million doses annually. Biological E has received approval for conducting Phase I/II clinical trials among 400 participants in India.
Bharat Biotech has developed Covaxin – India's first vaccine candidate for COVID-19 – in collaboration with the Indian Council of Medical Research, and the National Institute of Virology (NIV), Pune.
The COVID-19 strain was isolated by NIV and transferred to Bharat Biotech. It received go-ahead for Phase I trials in July, which was subsequently conducted among 375 volunteers across 12 sites. After assessing the safety data, the company initiated Phase II trials among 380 volunteers. Post assessing safety and immunogenicity data from the two trials, the company is progressing with Phase III trials, which will involve 28,500 subjects across 19 sites in 10 states.
The report said that the private players, in anticipation of possible demand, have begun ramping up capacity to distribute COVID-19 vaccines en masse when ready. The largest private player – Snowman Logistics – has capacity to store 650 million doses.
However, this assumes that all of the capacity is used only for vaccine storage. Practically, capacity available for vaccine distribution will be only 10-15 per cent of this or about 100 million doses for Snowman.
For the organised private cold chain storage industry, total vaccine storage capacity would be ~250-300 million doses.
"Our interaction with the industry suggests that bottleneck is not in the storage but in the number of refrigerated vans. The organised sector does not have reach extending to the hinterlands in the country and for those regions, it is likely that the government may utilise existing fruit and vegetable cold storage to achieve the purpose," the report said.
The key domestic logistics players with substantial cold storage business are Snowman Logistics, Gati Kausar, Transport Corporation of India, Mahindra Logistics and Future Supply Chain Solutions.