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AstraZeneca Plc and the University of Oxford face growing questions about the results of the COVID-19 vaccine trial after acknowledging a manufacturing error.
While an announcement earlier this week from Astra and Oxford showed that their shot was on average 70% effective in a late stage study, the few details released by the British partners raised concerns, with some voicing doubts about the fact that US regulators make it clear.
Astra and Oxford had said their vaccine was 90% effective when given half a dose before a full-dose booster. Two full doses showed 62% effectiveness. But the head of the US vaccination program known as Operation Warp Speed said the next day that the dose showing the highest level of effectiveness was tested in a younger population.
In a statement, Oxford said a difference in manufacturing processes led to later stages of trials with a half dose administered instead of a full one. When it became clear that a lower dose was used, it was discussed with regulators and an agreement was reached to move the two regimes forward, the statement said.
“Methods for measuring concentration are now established and we can guarantee that all vaccine batches are now equivalent,” according to the university.
Astra stock was up 0.5% Thursday after plunging 6.2% earlier in the week.
“The most likely explanation for the divergent efficacy in its interim analysis is case or patient demographics,” Bloomberg Intelligence analyst Sam Fazeli wrote in a statement. “In any case, approval based on current data means that people will be injected with a vaccine whose true efficacy is unknown.”
An Astra spokesperson said the trials were conducted “to the highest standards” and further analyzes are underway to refine the effectiveness reading.
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