Beyond the global candidates, Zydus, Bharat Biotech
and Biological E and Gennova are also working on their own Covid-19 vaccine candidates, currently in Phase-I and -II trial stages.
Biological E also has a partnership with Johnson and Johnson (J&J) through which it can manufacture and commercialise J&J's viral vector vaccine candidate. It has also recently acquired Akorn's manufacturing plant to supplement its manufacturing capacity to up to one billion doses. J&J recently published pre-clinical animal data for its vaccine. Two things stand out: A single dose seems to be effective, and almost all animals on challenge showed sterilising immunity.
Analysts at Bernstein said that Serum Institute of India
(SII) was best positioned to deliver the first vaccine.
While indigenous vaccine candidates are few, India scores highly on the global capacity equation. Among SII, Bharat Biotech, Biological E and some smaller players, India produces around 2.3 billion doses of various vaccines every year. SII is the largest manufacturer of vaccines globally, with a capacity of around 1.5 bn doses, to be scaled to 1.95 billion doses by the end of 2020.
With its existing capabilities and capacities, SII is best positioned to commercialise one or both of the partnered vaccine candidates, depending on approval timing, capacities and pricing, say analysts.
"We do not foresee any manufacturing scale-up challenges. The company is also investing in additional capacities of around 1 billion doses and we estimate it will be geared up to supply around 600 million doses in 2021 and around 1 billion doses in 2022. Of these, 400-500 million should be available for India in 2021, keeping in mind its other commitments to GAVI (Global Alliance for Vaccines and Immunisation) and low and medium income (LMIC) markets," Bernstein said.
While the pace of development is heartening, come 2021, these candidates will still lack evidence in a few areas compared to a normal vaccine development. Before Covid-19, the fastest vaccine to reach the market was the mumps vaccine, which had taken four years for approval. Regulatory authorities are, therefore, expected to start with emergency-use authorisation in high-risk subgroups and mandate extensive post marketing surveillance to monitor as well as wait for additional data in patient subgroups to expand label.
India commands 40 per cent of global capacity for vaccines which is estimated at 5.7 billion doses. The capacities are in excess of local demand and 74 per cent of the production is exported to address demand in LMICs through GAVI.
The vaccine market in India can be worth $6 billion over FY21-22
The Indian government is likely to procure 680 million doses. This will imply a spend of $1.9 billion for the government. If it chose to vaccinate the entire population, the government would need to set aside $6 billion ($1.3 billion to vaccinate 60 per cent for herd immunity, and considering 2 doses per individual at $3 per dose).
Bernstein analysts estimate that the volumes will be split 55:45 between the government channel and the private market.
SII has announced that GAVI will procure vaccines at a price of $3 per dose. Using that price as a benchmark, analysts estimate procurement prices to be $3 per dose for the government and $6 per dose in the private market. At least 60 per cent of the population will be given the vaccine for herd immunity. The government will pick up the tab for 50 per cent of the population to be immunised and the remainder will access the vaccine in the private market.
Bernstein analysts “assume that these prices will remain stable up to FY23. As more vaccines enter the market, it is quite possible that the prices will come down".
The private market, however, is expected to step in and supplement in terms of funding, manpower and delivery infrastructure. Cold and trained manpower would be the biggest challenges. Considering two times the current throughput, Bernstein estimates that the implementation of the government programme can take 18-20 months.
"Based on recent conversations with industry experts, we believe, the first set of vaccines in the government channel will be allocated to the most vulnerable population – healthcare workers, population over 65 years, followed by essential sector workers (defence, rail/road/air transport workers, etc), and then the economically weaker sections of the population (likely the Ayushman Bharat enrollees)," the report says. In the private channel, access to the vaccine will depend on affordability and will, therefore, start with the affluent population and then trickle down the income pyramid as more vaccines become available.