The UK’s tabloid press was having a field day. “NO, EU CAN’T HAVE OUR JABS” said the Daily Mail, a message echoed by the Daily Express with “WAIT YOUR TURN! SELFISH EU WANTS OUR VACCINES”. These headlines reflected a combination of triumphalism about the UK’s success in what, by common agreement, has been a remarkably successful vaccine rollout—especially when compared to the slower progress in the EU—anger that the decisions by certain national regulators a few days previously to suspend use of the Oxford AstraZeneca vaccine were somehow a punishment for Brexit, and indignation that these foreigners were trying to steal “our” vaccines. Inevitably, the reality is a little more complex.
To understand what has happened we need to go back to early 2020 when some of the key decisions were taken. The team at Oxford had produced a candidate vaccine in record time, but needed an industrial partner to bring it to market. Their initial choice was the US company Merck, which had extensive experience in manufacturing vaccines. However, this was greeted with alarm in Whitehall, as there was no guarantee that any vaccines produced by an American company would be available to the UK. Instead, the UK government insisted that Oxford reach an agreement with the Anglo-Swedish company AstraZeneca.
There was one important issue. AstraZeneca had no experience producing vaccines. The trials to assess safety and efficacy of the vaccine suffered from a series of problems. One subject developed unexplained neurological symptoms and the trials were paused. Clearly, there is always a risk when large numbers of healthy individuals are given a new product that some will experience unconnected events. The trials were soon restarted, although with some delay in the US arm. Then, 2741 subjects received half the intended dosage. This was less easily explained. However, the real problem was how both were communicated. There were clear contradictions in how the neurological problem was described in the company’s press statements, comments to investors, and internal documents. When the initial results from the trials were reported, the company focused on the figure of 90% efficacy in the group that inadvertently received the lower dose. Inevitably, this apparent success was welcomed, but soon questions were raised. Many details were missing and, contrary to best practice, the results of different trials had been combined. It was not immediately clear that the dosing difference was unplanned. Meanwhile, commentators struggled to ascertain whether the 90% figure was due to the longer delay in getting a second dose that was experienced by those getting the lower dose, or because they included few older people. Indeed, as it became clear that older people were under-represented in all the trial data, concerns grew about how effective the vaccine would be in these individuals.
These communication problems were only the start. Once production got underway it became clear that AstraZeneca was unable to deliver what it had promised. Again, this was understandable. Vaccine manufacture is extremely complex and the manufacturers of the other vaccines also faced problems. However, what was different was how each company responded. AstraZeneca had signed contracts with both the UK and EU authorities. It had agreed to deliver up to 120 million doses to the EU by the end of March 2021. Yet as the scale of the manufacturing problems emerged, it advised the EU that it could only promise 30 million doses, subsequently increased to 40 million. Understandably, the EU was unhappy, a situation not helped when it became clear that the EU was exporting millions of doses of vaccines, including to countries such as the UK that were also manufacturing vaccines, while receiving none in return. The resulting shortage had become the limiting factor holding up the vaccine rollout in several EU member states. Meanwhile, the UK was receiving vaccines from both its own factories and those in Belgium and India.
The reasons for this situation remain heavily contested, but the problem seems to lie with how AstraZeneca signed two contracts that were incompatible, given its manufacturing problems. Beyond that, however, the precise issues are far from clear. Gareth Davies, a law professor in Amsterdam, has written a helpful analysis of what we know and, crucially, what we do not know.
Seen in these ways, it is clear that the dispute is between the EU and AstraZeneca. However, a resolution is complicated by a severe breakdown in trust. In the midst of this dispute the company gave the impression that it had learned nothing from the issues with releasing the initial trial data. In an unprecedented development, the US National Institute of Allergy and Infectious Diseases reported being notified by the Data and Safety Monitoring Board for the US trial that “it was concerned by information released by AstraZeneca on initial data from its Covid-19 vaccine clinical trial.” Philippe Lamberts, co-leader of the Green group in the European Parliament, spoke for many when he said “It would seem AstraZeneca has a major problem of organisational culture. It’s a culture of unreliability.” Thierry Breton, the EU internal market commissioner, reported that while he was in “constant contact” with AstraZeneca, he had “not always received consistent explanations” about supply problems.
As if this was not enough, as noted at the beginning of this piece, this dispute is being reframed by some as a UK-EU dispute and indeed there was a danger that it could become one when the European Commission proposed making provisions for a possible ban on exports, something that was not supported by the European Council. However, perhaps inevitably, this was encouraged by the well-founded distrust in Brussels of the UK, which has breached its obligations under the Northern Ireland Protocol, so that the EU has had to take enforcement action. Fortunately, calmer voices have prevailed, perhaps by ensuring that the UK officials involved in negotiating the post-Brexit agreements, whose confrontational stance has been all too obvious, have been kept away from the discussions.
It has long been known that trust is a fundamental pre-requisite for a successful vaccination campaign. Normally, this is viewed as trust between those being invited to be vaccinated and those inviting them. This case is different, but the principles are the same. Regrettably this seems to be spilling over into public concern about this vaccine in some countries and there is a danger that it may do wider damage, given the existence of many groups and individuals that seek to exploit any concerns about vaccines. AstraZeneca certainly needs to take a long hard look at how it has handled this process and learn from it. The Oxford AstraZeneca team have developed a vaccine that is safe and effective. It would be a tragedy if their efforts were squandered by self inflicted actions that lead to a loss of trust.
Martin McKee, professor of European public health, London School of Hygiene & Tropical Medicine
Competing interests: MMK is a member of Independent SAGE in the UK and the European Commission’s Expert Panel on Investing in Health.