Notwithstanding increasing COVID-19 infections, several nations are coming out of self-imposed lockdowns after a severe economic battering. In the fight between lives and livelihoods, the latter seems to be winning the battle, at least for now.
Not surprisingly, the race to develop a vaccine for SARS-CoV-2 is being closely watched. Avoiding an economic catastrophe is as much the reason for this anxiety as saving lives is.
Currently, there are over 125 vaccine candidates under development. According to the World Health Organization (WHO), 10 of these were in the clinical trials, interestingly five of these by Chinese entities, while the rest are still in the pre-clinical stage.
By any standards, this is a humongous number of vaccine candidates for any single disease in human history. The reasons are not difficult to fathom. The magnitude of the pandemic apart, this is also a monumental make-or-break moment for global vaccine-makers who are currently in the heats before the actual race to supply the vaccine begins.
The stakes are high. First off, the block with a vaccine will mean millions, if not billions of dollars in sales for the successful companies that could be in the single digit even if governments invoke compulsory licensing to allow producers to make copycat vaccines based on successful candidates.
Size of the cake
So how large is the potential market for the vaccine? Scott Gottlieb, former Commissioner of the US Federal Drug Administration (FDA), reckons that by the time a vaccine is developed, roughly 20% of the global population would be infected. “So this would mean that we will have to vaccinate roughly 40% of the world population or 3.8 billion people to reach herd immunity,” he says.
This is a huge attraction for vaccine-makers to be first off the block to tap this potential.
While many governments, including India, have begun a campaign for an equitable pricing and supply of any vaccine that might come into the market, it is a given that most of it would be funded through national health systems at a subsidized cost.
However, if the current experience with testing kits is any indication, vaccine companies would nevertheless adopt a mixed marketing strategy supplying subsidized doses to government systems, while selling at a markup through private channels.
An indication of the likely pricing was available when Adar Poonawalla, Chief Executive of the Serum Institute of India told news agency Reuters that it would price the vaccine being developed in partnership with the University of Oxford at just ₹1,000 in India if the candidate is proven successful.
Even at this price, conservative by any standards, the tab for 3.8 billion doses works out to a whopping $50 billion dollars. And mind you, this is at Indian prices, which would be way below what is charged in many other countries. Moreover, one assumes only a single dose will be needed, which may not be the case at all.
Even granting that the vaccine-makers will be averse to profiteering from the pandemic, they are still looking at a bonanza. According to one estimate, the industry was valued at nearly $30 billion in 2018 and expected to grow to $43.79 billion at a compound annual growth rate (CAGR) of 10.3% through 2022.
Clearly then, a COVID-19 vaccine would be a watershed for the global vaccines industry, assuming there would be multiple companies out with their vaccines, catering to different segments of the market.
Pharma behemoths like GlaxoSmithKline, Merck & Co, Sanofi, and Pfizer currently lead the global vaccine market. However, COVID-19 could change the game with several smaller companies set to make a mark with their own vaccines.
However, just like any lottery, there are a lot of ifs and buts here too. For starters, nobody knows how far the world is from a tried, tested, and certified vaccine, which will have to go through the rigors of clinical trials and the gauntlet of regulatory approvals.
Second, there is no guarantee of a candidate actually coming out successful after all the time, effort, and money have been invested in developing it.
Third, there is no guarantee that a particular vaccine will immunize people against all the strains of SARS-CoV-2, which scientists report is prevalent in 11 variations across the world and is also likely to mutate over time.
In fact, the vaccine companies seem to be ones most aware of this risk and not surprisingly, most of them are hedging their bets and working on multiple candidates with multiple partners.
For instance, the Hyderabad-based Bharat Biotech is working on three candidates in collaboration with different global and national partners, apart from another project to produce antibodies to treat COVID-19 infected patients.
Likewise, Serum Institute too has reportedly partnered with US biotech firms Codagenix, Novavaz, and Austria’s Themis to manufacture three COVID-19 vaccines, apart from its deal to make the University of Oxford-AstraZeneca candidate successful.
Fast tracking the vaccine
Until a few years ago, it used to take anywhere up to 10 years to deliver a final, licensed vaccine — from research and discovery, to product registration — and cost anywhere between $200 million and $500 million, including the cost of abandoned candidates during the development process, according to one estimate published by the US NCBI.
For instance, scientists have been working on an AIDS vaccine for the past 20 years but still do not have it.
However, it is a different story with the SARS-COV2 vaccine development. The current-day DNA and RNA-based vaccine development platforms that use synthetic processes do not need the traditional culture or fermentation techniques that took a long time.
And thanks to the work put in by the Chinese in decoding the gene of the pathogen early, and the rapid development methodologies available today, the development is expected to be cut down to 18 months.
Recently, some labs have taken up the Human Challenge Trials (HCT) approach or the Controlled Human Infection Model studies, which they feel will further cut down the timeline by an additional six months.
Clearly, the scientific community is working at light speed on developing the vaccine that the pandemic demands. At the same time, however, the success rate and the costs are nevertheless the same as ever. However, the rewards from developing a successful candidate are more than attractive for the industry to ignore.
(The writer is a Hyderabad-based journalist and has covered business and technology trends for the last three decades)