AstraZeneca, Oxford first to publish final-stage vaccine trial results

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PARIS - Oxford University and AstraZeneca on Tuesday became the first COVID-19 vaccine makers to publish final-stage clinical trial data in a scientific journal, clearing a key hurdle in the global ra

ce to produce safe and effective drugs for the coronavirus.

Britain on Tuesday became the first country in the Western world to start immunizations, using a rival vaccine developed by Pfizer-BioNTech after approving it for general use last week. Andrew Pollard, the director of the Oxford Vaccine Group who led the study, said publication showed developers were sharing data "transparently", adding that a range of vaccines would be needed.

AstraZeneca and Oxford faced questions about their results when they released an overview last month, after it emerged that the half dose was given because of a mistake. Pollard said once researchers realized the measurement discrepancy, it was incorporated into the trial with the agreement of regulators. AstraZeneca said it would be up to regulators to decide dosing recommendations based on the data provided.The results are likely to present a "dilemma" for drug authorities, said Simon Clarke, Associate Professor in Cellular Microbiology at the University of Reading.

To calculate efficacy the authors analyzed data from phase 3 -- final stage -- clinical trials in Britain and Brazil, involving 11,636 people, half of whom had the vaccine of either dosage and the other half a placebo.

 

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