corporAID: The current debate about a Covid-19 vaccine is highly ideological. How do you see the distribution of roles between the private and public sectors?
Chalkidou: Especially in the context of Covid-19, the crucial importance of public-private partnerships has become clear. The current debate is taking on disturbing forms. Take the example of Operation Warp Speed: This is where the US government stepped in and said that - come what may - we would have a vaccine by the end of the year. This suggests to people that governments can replace the private sector and vice versa. Sure, the financial commitment of governments in vaccine development or research into new treatments, as we are currently experiencing, is unparalleled. Nevertheless, products cannot be developed in a vacuum; the entire system is required: the infrastructure, universities and basic research as well as well-regulated markets. Pharmaceutical companies, with all their capacities, play an important role in the development process from research and development to the production and commercialization of accessible and innovative medical goods.
What do you think of calls to make the future Covid-19 vaccine a global public good in order to ensure fair access?
Chalkidou: I consider this discussion to be irrelevant. The questions of access and pricing are of course important, but at the core it should be about more transparency and careful processes. And it must be a matter of linking the award of contracts and purchase guarantees to companies with the effectiveness and effectiveness of the end product. That is not the case today: what we are seeing instead is a kind of arms race. Individual countries are trying to secure enough vaccine doses with very little regard for the distribution of benefit and risk. The general public does not know which contracts in these pre-purchase commitments have been signed by different countries including the EU Commission. Many due diligence processes are currently being completely neglected, and that is very problematic
Where should one start specifically?
Chalkidou: First of all, states must clearly signal to the manufacturers that this is an exceptional situation, but that they are ultimately interested in a product that works. And that official approval as the sole criterion is not enough. When a vaccine hits the market and regulators say it's safe and effective, it doesn't automatically mean we should all get it. National governments have an obligation to thoroughly evaluate health technologies. In addition to the regulatory process in which the price-performance ratio of a product is checked, the comparative effectiveness that the product offers in a certain future situation must also be taken into account. This is of course difficult under the circumstances, because we do not know where we will be in three or six months. Perhaps by then there will be a miracle antiviral drug that will prevent people from going to intensive care and actually being rescued. Or maybe 50 or 60 percent of people have already been infected in some way, so that we only protect the population at risk and keep the hospitals running, but not all of us have to be vaccinated. What is needed now is transparent decision-making, in which the facts and the end use of the vaccine and other products are clearly signaled to companies and the population. This requires a proper process in which it is evaluated at national level what works under the given circumstances when these products are brought to market. And in the medium term, the aim must be to create functioning markets instead of committing to specific products.
To what extent does the Covax mechanism take these points into account?
Chalkidou: The Covax mechanism mentions this double obligation - at an early stage for certain products and then in the medium term for the creation of a market for any product that fulfills predefined properties. But there is a lack of details as to what an assessment beyond the prequalification by the WHO will look like. WHO prequalification is a necessary but not a sufficient condition, as we saw in 2017 using the example of the dengue vaccine. This was pre-qualified according to WHO criteria and then advertised in countries with a dengue problem, e.g. in the Philippines. It turned out, however, that people who had previously been exposed to dengue viruses develop an increased reaction, which, incidentally, is also a concern with the Covid-19 vaccine. This caused some deaths and a major scandal across the country. The manufacturer had to withdraw all vaccines from the market and there were general concerns about the safety of vaccines among the population. Ultimately, in addition to losing human life and trust, it was also a waste of money.
What should we learn from this?
Chalkidou: That a single process that takes a close look at the effectiveness and safety of a vaccine, i.e. does not include the context-specific alternatives and uncertainties, is not sufficient. National governments and the European Commission need to think about regulatory safeguards that go beyond market approval. The WHO target profile for vaccination against Covid-19 is at least 50 percent or even less effective. 50 percent effectiveness is like tossing a coin. I think we need an independent process that takes realities into account. This is nothing new! But for some reason, in the face of the emergency, everything was sped up and many proper test and evaluation bodies were dropped. Now it's time to reintroduce them because there won't be a vaccine tomorrow. So we have enough time to reconsider these compromises.