As countries shift from national lockdowns, to local lockdowns, air bridges and the quarantining of individual communities, there is understandably a desire for a permanent solution to COVID-19. The most obvious ‘golden ticket’ is a vaccine.
Across the world, billions of pounds are being poured into over 140 organisations for the development of such a vaccine – with the UK alone placing orders for six potential vaccines (taking its prospective stockpile to over 340million doses). Whilst the Government has not disclosed the amount spent on buying up this supply, if the US deal with BioNTech and Pfizer is anything to go by, the costs will easily run into the billions of pounds.
The secrecy of these deals is particularly worrying. Whilst we can estimate what the price per dose is, we shouldn’t have to be making these back-of-the-envelope calculations. Without full transparency, we have no means of knowing how huge amounts of public money is being used, and that’s before you take into account government investment that has already gone into funding the scientific research and development of a vaccine. At a global level these bilateral deals also risk undermining equitable global access to a vaccine, with wealthier nations who can better afford to pay and with better reference points, nudging out those who are poorer and operating from a weaker negotiating position.
It is also important to take stock of the fact vaccines usually take years to develop and the current process has been dramatically sped up, creating the prospect that a vaccine will be created which either doesn’t work or carries severe risks. Either of these outcomes could do irrevocable damage to public trust in the effectiveness of vaccines. This would be especially grave in the present but also in maintaining public confidence in the regular vaccination programmes that many countries are already struggling to deliver alongside pandemic response.
Of course, pharmaceutical companies are well aware of these risks and the potential liability claims they might face in the reality of an unsafe vaccine. So, it’s perhaps not surprising that, in order to negotiate a lower price, the EU has reportedly agreed to a cap on the legal costs that the pharmaceutical company, AstraZeneca, would have to pay in the result of any vaccine side effects. This is a reflection of the EU Commission Strategy for COVID-19 Vaccines which stated: “the liability for the development and use of the vaccine, including any specific indemnification required by a given APA {Advanced Pricing Agreements} will remain with the purchasing Member States”. This liability is normally assumed by the pharmaceutical company manufacturing the drug.
Such clauses, like that in the EU Commission Strategy, have raised alarm from patient organisations who have called for an EU-wide compensation scheme funded by pharmaceutical companies, not public money. It is of immense concern that amidst the rush to develop a vaccine, pharmaceutical companies have successfully lobbied to effectively be waived of the responsibilities usually expected of them if anything goes wrong. Accountability is essential to combatting this crisis effectively and the approach currently being taken across the EU suggests that accountability may be being watered down for the sake of rapid solutions. Pascal Canfin, Chair of the European Parliament’s Health Committee, recently echoed these concerns over accountability stating: “We have very little information on the content of the contracts that have been signed by the European Commission and some laboratories”.
Nonetheless, despite the obvious issues, the recent pledge from top pharmaceutical companies on meeting expected safety and regulatory standards in their race to develop a vaccine is of some welcome. It has been promising to see two companies who are leading the vaccine race, Pfizer and Moderna, publishing their clinical trial protocols, something that is typically done following the completion of trials. This is important as it allows external scrutiny of the protocol by experts and builds confidence in a process that has experienced waning trust following high profile cases of research fraud and weak methodology elsewhere in the COVID research space. Acts of transparency such as these are essential to creating public trust. Moving forwards, we will look to other companies to follow suit and for this to become a normal practice.
As governments and pharmaceutical companies continue with the development of a vaccine – with some already in Phase 3 trials – and countries such as Russia announce the creation of a vaccine; it is imperative that there is full transparency and accountability. This is not optional, and it should be clear across all the aspects, pricing and agreements of the whole COVID-vaccine development process.
We all want a vaccine, but it should not be at the expense of a lack of transparency and accountability.