- New data published about the Oxford AstraZeneca coronavirus vaccine shows promising efficacy data.
- However, there’s a caveat: It seems that the vaccine was shown to be 90% effective only in a small group that got a half-dose of the vaccine first.
- This may lead regulators in the UK, US, and Europe to come to different conclusions about the vaccine.
AstraZeneca and Oxford had announced the Phase 3 interim data a few days ago for their experimental coronavirus vaccine candidate, revealing that the drug is 70% effective on average. Pfizer and Moderna both reported efficacy that’s even better than Oxford’s results — but, now, more data has been revealed about the Oxford coronavirus vaccine which seems both exciting, at first glance, but which also may pose a bit of a quandary for regulatory bodies tasked with approving the vaccine candidates.
Basically, according to new trial data published in the Lancet, Oxford University and its partner AstraZeneca are, yes, hoping to get the regulatory nod for their vaccine on the basis of its 70% efficacy, which was achieved after collecting trial results from Brazil and the UK. However, it seems that the vaccine’s efficacy is 90% in a subset of the vaccine trial candidates who got a half-dose first — while the vaccine only has 62% efficacy for the majority.
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Among other things, this will mean that regulators in the US, UK, and Europe will have to work out what the appropriate dosing regiment should be, assuming this vaccine wins approval. Because the data seems to be so different for different groups, regulators in different parts of the world may also arrive at different conclusions to this question.
“Our job as scientists is to generate the data and make that publicly available for people to scrutinize and scientists to scrutinize — and also, now, for the regulators and policymakers to scrutinize,” Oxford University professor and chief investigator on the trials Andrew Pollard said, per The Guardian. “These decisions are not for us to make.”
In terms of what else we already knew about the Oxford coronavirus vaccine, it’s cheaper to mass produce than the Pfizer and Moderna vaccines and will thus be significantly more affordable to governments. The Oxford drug can also survive at regular fridge temperatures, which means it can be transported and distributed easier than the others. However, it’s expected that the FDA will take longer to approve (or not approve) this vaccine candidate in the US, compared to the speed of regulators in the UK and Europe.
Since most participants in the Oxford trials were under age 55, the FDA has also expressed a concern about that, as well as “limited ethnicity data,” according to The Guardian.
“We will be submitting the data to the FDA, but our best assumption is that we will need the study readout from the US before we are likely to get approval in the US,” said Mene Pangalos, executive vice president of bio-pharmaceuticals R&D at AstraZeneca.