After admitting mistake, AstraZeneca faces tough questions about vaccine

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Bigger problems quickly arose.

An AstraZeneca executive told Reuters on Monday that the company did not expect participants to receive half the dose. The British researchers conducting the trial there had initially wanted to give the full dose to the volunteers, but a miscalculation meant that they had mistakenly received only half a dose. The executive, Menelas Pangalos, called the mistake a “coincidence”, allowing researchers to come up with a more promising dosing schedule.

For many outside experts, this compromises the credibility of the results because tightly calibrated clinical trials were not designed to test the effectiveness of an initial dose at half strength.

The company’s initial announcement did not mention the accidental nature of the find.

In the statement attributed to Oxford, Ms Meixell, spokeswoman for AstraZeneca, said the error stemmed from an issue, which has since been resolved, with the way some of the vaccine doses were manufactured.

Then, on Tuesday, Moncef Slaoui, head of Operation Warp Speed, the US initiative to speed up coronavirus vaccines, noted another limitation in AstraZeneca data. On a call with reporters, he suggested that participants who received the initial half-strength dose were 55 or younger. Ms Meixell declined to say whether this was the case, noting that the data would soon be published in a peer-reviewed journal.

If the initial half-dose were not tested in older participants, who are particularly vulnerable to Covid-19, it would hurt AstraZeneca’s case for regulators that the vaccine should be cleared for emergency use.

Food and Drug Administration spokesperson Stephanie Caccomo declined to say whether the dosing error would hurt the vaccine’s chances of being cleared. The FDA has said it expects the vaccines to be at least 50% effective in preventing or reducing the severity of the disease, a bar the vaccine appears to have eliminated even in the group that received both doses. complete.

AstraZeneca shares have fallen around 5% this week, while broader stock indexes have hit record highs. Investors appear to be disappointed with the murky results, especially compared to the much clearer data released by two of AstraZeneca’s main rivals in the coronavirus vaccine race.

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