Martina Di Maggio
Martina is a consultant specialising in market access, health economics and outcomes research.
Currently over 160 vaccine candidates are racing to prove clinical effectiveness in COVID-19 trials across the globe, and every day we hear conversations around what will happen after the eventual arrival of a coronavirus vaccine - offices reopening, weddings going ahead, reunions with family, holidays abroad.
Despite public imagination though, crossing that red ribbon at the finish line won’t mean a glory-basked, picture-perfect spot on the podium; at least not straight away. Establishing effectiveness opens the doors to several socioeconomic issues the companies that own the patent rights will have to overcome, all while jumping through hoops held by major governments and regulatory bodies.
For a COVID-19 vaccine to reach approval stage it’ll have to establish immunity in at least 70% of the population. So, let’s say we wake up tomorrow and a major frontrunner has announced such a result; what needs to be considered before it reaches us?
Finding the balance between intellectual property rights and serving the public good is a challenge that vaccine developers have always had to navigate. The rights to a vaccine patent provides developers a way to recover the costs of R&D, and as with any therapeutic, deals are written up between the private companies leading the development and the public bodies invested in ensuring access.
The urgency we’re seeing in the case of COVID-19 doesn’t come close to anything else we’ve seen in our lifetime, and it leaves governing bodies in a position where pre-emptive deals are being closed without knowing which candidate, if any, will prove effective.
Last month the European Commission announced a deal with French pharmaceutical company Sanofi for 300 million doses of a possible future vaccine, and it’s just one of the major pre-emptive deals being closed. These down-payments for vaccines that may never make it to market may seem risky, but when a process that usually takes 10+ years is being given an optimistic forecast of 12-18 months, it leaves far less time to consider the financial aspects.
With deals being drawn up between governments and the organisations controlling the patent, it’s easy to conclude that nations with the deepest pockets will end up with first access. Even if a vaccine can be mass produced, there’s no clear way to force nations to distribute this fairly outside of their patented countries. During the 2009 H1N1 flu pandemic, Australia was amongst the first to manufacture a vaccine. They, however, chose not to immediately export it in order to prioritise their own citizens. How can we ensure something like this doesn’t happen on a larger scale with a COVID vaccine?
It’s a challenge that has to be addressed collectively by governments, health leaders and regulatory bodies, and one that’s been talked about since the pandemic broke.
A major scheme launched by Gavi and the World Health Organisation, COVAX, sets to counter this threat of ‘vaccine nationalism’ by setting an allocation that ensures a new vaccine is shared equally between the world’s wealthiest economies and those in the developing world.
At the time of writing, 156 countries have signed the deal, which seems like great news for market access. But the scheme is currently far short of raising the $18billion it’s estimated it will need from donors to scale up production and ensure access to low-income countries. It also leaves wealthier countries in charge of purchasing their own allocation, and as it stands, more than two billion doses are set aside just for Europe, the US and a handful of other wealthy economies.
Even if a vaccine gains approval within 18 months, there won’t be enough for everyone.
Countries signed up to the COVAX scheme are set to receive vaccine doses for 3% of their population during the first stage of roll-out, which will then increase to 20% for the second stage and then more as production ramps up. It’ll be down to individual governments and public health bodies to decide the criteria and strategy for allocation at each stage.
The two major populations discussed when considering who should get priority access are healthcare and social care front-line workers, who the World Health Organisation have suggested prioritising for the first roll-out, and the clinically vulnerable or high-risk.
The framework will differ from country to country, with each basing their approach on evidence on the rate of transmission, most severe health effects and their national economy. This means that the average person may not receive a vaccine for a number of months, even years, after initial production.
So much is still unknown, and decisions that might’ve seemed clear-cut back in March have been turned on their head as we learn more about the virus and how it’s transmitted.
What is clear is that a vaccine won’t be providing some silver-screen-style heroic ending to a time of bleak uncertainty; the fight against COVID-19 is one that will be won gradually, and at a high cost to governments, the global economy and our everyday lives.