- Several European countries have paused the roll-out of the AstraZeneca/Oxford vaccine on concerns over elevated levels of blood clotting
- 11m AstraZeneca/Oxford vaccine doses have been administered in the UK, with only 40 embolism cases recorded
An investigation into the cause of blood clots has led several of Europe’s medicines regulators to pause the roll-out of the AstraZeneca/Oxford vaccine after cases came to light in Norway, Ireland and Germany. Regulators will meet to discuss the significance of these cases in the context of a programme that has seen 17m Oxford jabs administered so far, 11m of those in the UK alone.
The questions for pharmaceutical market watchers are whether there is any real scientific basis for worries about the vaccine, whether it is just another example of creeping ‘vaccine nationalism’ and whether it will have any conceivable commercial impact on AstraZeneca?
It should, however, be noted that the European regulators have said the hiatus is a pause to gather and consider data and is not classified as a formal safety-related event – despite comments from the director-general of the Italian medical regulator that the decision is a “political one”. Indeed, it is fair to say that AstraZeneca (AZ.) hasn’t had the easiest ride with the EU, after catching the full brunt of the European Commission’s displeasure over lagging delivery times caused by production issues at sites in Belgium. Anecdotal evidence from Germany and France is that the initial bad press – President Macron calling it “quasi-ineffective” – and the ban in Germany (now lifted) on administering the vaccine to the over-65s, the group at greatest corona risk – was already leading to batches being wasted due to patients’ refusal to accept the jab, even before the latest regulator-imposed pause. This also comes against a backdrop of rapidly mounting criticism, particularly in Germany and France, of the slow pace of the vaccination programme compared with the UK, Israel and the US.
It is here that we notice the quirks in healthcare systems. Germany’s largely devolved healthcare system has struggled to effectively coordinate a mass vaccination programme because there simply is no one authority that controls a unified health database. Some in the country are even resorting to booking their vaccination appointments from overseas servers to bypass the country’s jammed online booking systems.
The undoubted success of the UK’s vaccination programme, meanwhile, is down to the fact that the NHS can use its central control of data to match demand with resources quickly; conjuring up vaccination centres in unlikely places (a former cattle market near Exeter, for instance) or overseeing the training of thousands of volunteer vaccinators.
Statistics, statistics, statistics
The regulators must work out whether the blood clot cases have any statistical significance – which would tie them to the vaccine itself – or whether these would have happened anyway within the context of immunising an entire population.
Deep vein thrombosis (DVT), or embolism events (embolisms happen in the lungs) are far more common than supposed. They can strike perfectly healthy people who might, for instance, be sitting still for long periods on long-haul flights. The Centers for Disease Control in the US estimates that they commonly affect around 1 in 1,000 people and are dependent on lifestyle factors and unlucky genetics. The other problem is that they are sometimes not detected and recorded properly.
This begs the question as to whether the DVT/embolism cases that have been recorded in the aftermath of receiving the vaccine – AstraZeneca cites fewer than 40 noted so far – would have happened anyway given the profile of those receiving the jab – people in their 70s and 80s who might already be suffering from other forms of ill health. The blood thinner Warfarin, for instance, is the most prescribed medicine after blood pressure regulator statins.
Although it sounds vaguely ominous “pause and assess” is an accepted practice in medicines safety when adequate data is not yet available. Whether this is appropriate at a time of a fast-moving and rapidly changing pandemic is open to question, but the Italian regulator has said that once “doubts are cleared we can carry on at a faster speed than before”.
Fundamentally, regulators would need to find some very compelling evidence before withdrawing or restricting the vaccine. One NHS doctor involved in the mass vaccination programme told Investors’ Chronicle, “basically, the Oxford vaccine is a ‘traditional vaccine’ that is based on technology that has decades of safety data behind it. Biological medicines (the basis for the Pfizer jab) is very new science by comparison”.
The business of vaccines
Assessing the commercial impact on AstraZeneca is very tricky indeed. It is probably best to take a step back and look at the overall picture. Prior to the coronavirus pandemic, vaccines were a growing, but essentially unimportant part of global pharmaceutical industry revenues worth about 2 per cent of total global revenues, or $33bn annually. The value comes in their relatively higher margins and the fact around 68 per cent of revenues originate in wealthy countries with established vaccination programmes and who have the cash to pay for them.
The pandemic has led to a reassessment of vaccines’ dull-but-worthy status, not least because of the advanced science used to develop Covid vaccines and its potential applications for other diseases. While GlaxoSmithKline (GSK) enjoys higher margins in its vaccines business, the fact remains that despite the current scrutiny, Astra’s ramp-up of the Covid vaccine is going to leave it with greater vaccine manufacturing capacity and, with a lower-priced vaccine than rivals, a significant opportunity outside of western markets and away from the politicisation of Covid vaccines.
