November 26, 2024

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For a man presenting landmark results from trials of a vaccine that it is hoped will save the world from a devastating pandemic, Sir Menelas Pangalos did not look cheerful on Wednesday.

Pangalos, executive vice-president of biopharmaceuticals R&D at AstraZeneca, and his colleagues are undoubtedly exhausted, having been working round the clock on the coronavirus vaccine with Oxford University since April. But they are now dealing with a sizeable new headache – the doubts of the US regulator.

It is clear that in spite of the critical need for coronavirus vaccines, the Food and Drug Administration is not going to rush to approve the vaccine developed by Oxford University and AstraZeneca, even though the US, through its “Operation Warp Speed”, has put in substantial funding and ordered 300m doses.

Unlike Pfizer/BioNTech and Moderna’s mRNA products, the AstraZeneca vaccine is cheap, can be stored at ordinary fridge temperatures, is easy to manufacture and presents the best hope at the moment for a vaccine for the billions rather than the few.

But while the UK, the rest of Europe, and Canada and India could approve it in the coming weeks, the US, which currently has the world’s biggest epidemic, will have to wait.

The Oxford/AstraZeneca vaccine has been the subject of withering criticism in the US media. It has suffered by comparison with Pfizer and Moderna, whose vaccines, manufactured with a different and novel technology, have effectively scored straight As. Their vaccines have shown 95% efficacy in very large and straightforward trials involving respectively more than 40,000 and 30,000 people.

Criticism of the AstraZeneca vaccine focuses on three main issues. AstraZeneca’s efficacy data relates to fewer people than the other vaccines; so far 11,636 in the UK and Brazil trials, although there are more to come, including a 30,000-strong trial in the US partly funded by Operation Warp Speed.

A woman in the UK given the AstraZeneca jab developed transverse myelitis, a neurological disorder causing inflammation of the spinal cord, leading to the trials being paused worldwide in September. And the efficacy results were 62% overall, but 90% covering a sub-group of fewer than 3,000 people who were inadvertently given a lower starting dose.

Researchers said that pooling the results, which they had agreed to do with regulators before they knew the outcome, gave them 70% efficacy overall.

But it looked messy. One investment analyst opined at that point: “We believe that this product will never be licensed in the US.”

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