WASHINGTON (REUTERS) – AstraZeneca will share primary analysis of its Covid-19 vaccine with the most up-to-date data with an independent panel looking into its US trial, the drugmaker said on Tuesday (March 23), following doubts expressed by a US health body over the trial data.
The Anglo-Swedish drugmaker said data presented on Monday was based on analysis with a cut-off date of Feb 17, adding that it had reviewed the preliminary assessment of the primary analysis and found it to be consistent with the interim report.
“We will immediately engage with the independent data safety monitoring board (DSMB)…. We intend to issue results of the primary analysis within 48 hours,” AstraZeneca said.
The firm will also provide Europe’s drug regulator with data from a US trial and the watchdog could adjust its assessment of the shot if needed, the head of the European Medicines Agency (EMA) said on Tuesday.
“The trials point to greater efficacy than what we actually observed in the previous trials that we examined,” EMA chief Emer Cooke told members of the European Parliament.
Ms Cooke, however, did not deliberate much on doubts expressed by US federal health officials that AstraZeneca may have used “outdated information” in the data released on Monday.
“The company has promised to provide us with (data) and we will adjust our assessment if there is any new information that needs to be taken into account,” she said.
The AstraZeneca-Oxford vaccine was shown to be 79 per cent effective in preventing symptomatic illness and did not increase risk of blood clots, according to interim data from the late-stage trials in Chile, Peru and the United States.
Earlier, the DSMB in the US said AstraZeneca might have released outdated information on its latest Covid-19 vaccine trial, giving an “incomplete” picture of its efficacy, casting doubt on the shot’s potential US roll-out and plunging its developers, once again, into controversy.
The surprise public rebuke from federal health officials came just one day after interim data from the drugmaker showed better-than-expected results from the US trial. That had been seen as a scientific counter to concerns that have dogged the shot over its effectiveness and possible side effects.
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