Sunday, March 21, 2021

USA IS DUMPING THEIR AZ ON CANADA & MEXICO
Brexit blinds Britain to AstraZeneca’s blunders
Lack of transparency on Oxford-developed vaccine fuel for European and US caution

Sat, Mar 20, 2021
Ruadhán Mac Cormaic

AstraZeneca vaccinations in Lichfield cathedral: British ministers treat every question about the safety or effectiveness of the drug as a grievous insult to national honour. Photograph: Oli Scarff


When a single issue defines a country’s politics for as long as Brexit has England’s, it’s perhaps inevitable that, after a while, it can be hard to see beyond it. For a country still finding its feet after the biggest shock to its international position since the war, everything seems somehow connected to the decision to leave.

It was striking, in British reaction to the suspension of use of the AstraZeneca vaccine across Europe this week, how it was reflexively assumed that the British origins of the product (it was developed in Oxford) was at the root of EU attitudes to it. “The European Union would rather see their people die than the United Kingdom succeed. They have smeared the brilliant cheap efficient AstraZeneca vaccine – an act of medical stupidity and political insanity,” wrote Tony Parsons, a polemical columnist.

British ministers treat every question about the safety or effectiveness of the vaccine as a grievous insult to national honour. Even some Remainers ask whether EU scepticism towards the AstraZeneca jab springs from the continental view that Britain is run by cowboys.
The vaccine is treated as a national champion, a symbol of British pluck and ingenuity. That link is seldom drawn in EU

There is no denying that European leaders have found it galling to see the UK sprint ahead in the vaccine race. The rapid start in the UK, as well as in the US and Israel, has increased domestic pressure on those leaders, even if delivery schedules in the EU and the UK suggest the continent will largely have closed the gap by early summer. But the Brexiteers’ conspiracy theory doesn’t hold up to any real scrutiny. In England, “the Oxford vaccine” is treated as a national champion, a symbol of British pluck and ingenuity.

That link is seldom drawn in the EU, where “the British vaccine” is a formulation applied as rarely to the AstraZeneca jab as “the German vaccine” is used to refer to the one developed in Mainz* by BioNTech and produced by the US pharma giant Pfizer. AstraZeneca is an Anglo-Swedish firm run by a Frenchman. The biggest share of investment in its vaccine came from the US and the bulk of its production is happening in India. The multinational Oxford vaccine team is jointly led by a scientist from Dublin.

Capacity overestimation

As with any conspiracy theory, this one overlooks the straightforward and obvious reason for EU caution: its trust in AstraZeneca was shaken from early on and has never recovered. The Oxford/AstraZeneca team managed an extraordinary feat – producing a safe and effective vaccine against a novel coronavirus within a few months. Yet time and again, AstraZeneca has undermined its own efforts with communication blunders, a lack of transparency and a consistent record of overestimating its own capacity to deliver.

Relations between the EU and AstraZeneca have been poisonous since January, when the company slashed its delivery estimates for the first quarter of the year from 100 million to just 30 million – without adequate explanation or notice, as the EU saw it.

Governments and regulators can be forgiven for being cautious – and for reasons that have nothing to do with Brexit

Having talked up its programme through last spring and summer – AstraZeneca originally said it would deliver vaccines by October 2020 – the company made its biggest error in November, when the release of confusing results from its phase-three clinical trials raised eyebrows around the world. A press release announcing the results said that, depending on dosage, the vaccine was either 62 or 90 per cent effective. But it was US authorities which revealed the higher efficacy rate applied only to a small sample of patients aged under 55.

Nor did AstraZeneca disclose at first that the more efficacious dosage combination (a half-dose followed by a full one) was the unplanned result of a contract manufacturer producing a half-dose by accident. Production delays during the trial meant many of those participants received the second dose after an extended interval. (It is now believed that the higher efficacy was probably due to the longer interval, meaning the production delay turned out to be very useful).

Confusion and scepticism


In London, Boris Johnson hailed the “incredibly exciting” results. But while the results were strong, the lack of transparency shook regulators’ confidence. AstraZeneca’s stock fell. Governments worried that the confusion would feed vaccine scepticism. Moncef Slaoui, head of the US vaccine taskforce, suggested the difference in efficacy rates could be “random”.

Meanwhile, the US Food and Drug Administration had reacted angrily when it learned from the media that AstraZeneca had temporarily halted its trials around the world after a participant in Britain fell ill. The US had invested $1 billion in the vaccine and felt it should have been kept informed. The upshot of American concerns is that AstraZeneca had yet even to apply for approval there; as a result some 30 million doses are sitting unused in American warehouses. The outcome of a new phase-three trial involving 30,000 participants is due to be disclosed in coming days.

Studies of the AstraZeneca vaccine’s efficacy in the real world have been highly encouraging, with a recent analysis of 17,000 people showing it offers 82 per cent protection against the virus after the second dose. The green light from the European Medicines Agency on Thursday has cleared the way for states to use it again, and the company expects to be able to ramp up production in the second quarter. But governments and regulators can be forgiven for being cautious – and for reasons that have nothing to do with Brexit.

*This article was amended on March 20th, 2021


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