New Delhi, Nov 12: The key vaccines India is banking on are from Oxford/AstraZeneca, Novavax and J&J and the earliest efficacy data is expected by the end of November-December 2020 and in the best case, vaccines can be rolled out in January 2021.

According to a research by Credit Suisse, India needs about 1.7 billion Covid-19 vaccine doses to vaccinate majority of its adult population. It targets to administer 400-500 million doses by July 2021. Pfizer COVID-19 Vaccine Distribution in US Intended to Begin From December, Says Health Secretary Alex Azar.

"The key vaccines India is banking on are from Oxford/AstraZeneca, Novavax and J&J (temperature range is 2-8-degree Celsius) and the earliest efficacy data is expected by the end of November-December and in the best case, vaccines can be rolled out in January 2021," the report said.

Credit Suisse said there is sufficient capacity for vaccine manufacturing (more than 2.4 billion doses) and various components like vials, stoppers, syringes, gauze, alcohol swabs, etc.

The bottleneck is cold storage infrastructure (especially refrigerated vans) and by using a part of the capacity of current immunisation programme (600 million doses) and the cold chain infrastructure of the private sector (250-300 million doses), potential vaccinations can reach 550-600 million doses annually. Manpower required for administering the vaccine will be less than 1 lakh.

Aurobindo's large viral vector vaccine facility (300 million doses) should be ready by March-April 2021. The pricing in export markets could be higher than in India and profitability could be at Rs 20-25 per dose and, therefore, on a 300 million dose capacity, Aurobindo could benefit from a potential EBITDA of Rs 6-7.5 billion (or 12-15 per cent of FY22E EBITDA).

Cadila also has facility for 100 million doses but it is for DNA vaccine and, therefore, would not be able to manufacture vaccine from global players in the near term, the report said.

Apollo Hospitals has infrastructure to administer 100 million doses annually and this can add Rs 2.5 billion EBITDA.

Diagnostic companies (Metropolis) should also benefit from an increase in demand for antibody tests (both before and after vaccination) but their pricing can sharply come down.

Higher vaccination will impact volumes of Covid-19 treatment drugs. Cipla and Cadila have benefited the most from the sale of Covid-19 treatment drugs (especially Remdesivir) in 2Q FY21 and the volume should substantially reduce in FY22 on increasing vaccination.

The key vaccines India is banking on are from Oxford/AstraZeneca, Novavax, and J&J as the temperature range of these vaccines is about 2-8-degree Celsius (vs -20-degree Celsius for Moderna and -70-degree Celsius for Pfizer).

The key bottleneck is likely to be cold storage capacity. The Covid-19 vaccination will have to use a part of the infrastructure of the current immunisation programme (27,000 cold chain points catering to 600 million doses) and would need support of the private sector too.

Organised private cold chain companies can at best handle 250-300 million doses (bottleneck is refrigerated vans rather than storage). Further, the reach of private sector cold storage doesn't extend to the hinterland and for that another solution needs to be devised.

"Overall, with bottleneck on cold chain infrastructure, we estimate annual vaccinations may be just around 550-600 million doses. Skilled manpower required to administer 550-600 million doses is less than 1 lakh which should not prove to be a bottleneck," the report said.

"Our demand estimate for population to be vaccinated assumes 25 per cent of the population already being infected by March 2021 (most sero-studies already pointing to 20 per cent plus positive infection rate). Most of the global vaccines have done trials only on population set of above 12-15 years, as per current protocols, and requirement of two doses per person (the exception is J&J vaccine which is a single dose vaccine). These assumptions lead to requirement of 1.7 billion doses, assuming that no repeat vaccinations are needed," the report added.

The government has already started preparing the database of priority beneficiaries. It has issued an advisory at district and state levels to prepare a database of both public and private healthcare workers, and subsequently upload it to the Covid-19 Vaccine Beneficiary Management System, which is currently under works.

The database of healthcare workers is expected to be finalised shortly, whereas the database of people above 50 years and frontline workers is already in place.

However, the key challenge would be to prepare the database of people with comorbidities, where the data is currently limited to screening of people at 48,000 health centers.

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.

(The above story first appeared on LatestLY on Nov 12, 2020 09:18 AM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).