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Two different dosing regimens demonstrated efficacy with one showing vaccine efficacy of 90% with no serious safety events noted.
November 23, 2020
By: Contract Pharma
Contract Pharma Staff
AstraZeneca’s COVID-19 vaccine candidate, AZD1222, met the primary efficacy endpoint in preventing COVID-19. Analysis included data from COV002 Phase II/III trial in the UK and COV 0003 Phase III trial in Brazil, involving 23,000 participants. Two different dosing regimens were assessed and demonstrated efficacy.
One dosing regimen (n=2,741) showed vaccine efficacy of 90% when AZD1222 was given as a half dose followed by a full dose at least one month apart, and another dosing regimen (n=8,895) showed 62% efficacy when given two full doses at least one month apart. No hospitalizations or severe cases of COVID-19 in participants treated with AZD1222 were reported and no serious safety events related to the vaccine were noted.
AstraZeneca will prepare regulatory submission of data to authorities around the world that have a framework in place for conditional or early approval.
In September, Oxford Biomedica signed a three year Master Supply and Development Agreement with AstraZeneca for large-scale commercial manufacture of their COVID-19 vaccine candidate, AZD1222. Under the agreement, AstraZeneca paid Oxford Biomedica £15 million upfront as a capacity reservation fee and the Group expects to receive more than £35 million for large-scale manufacture of multiple batches of ADZ1222 until the end of 2021, subject to continuation of the program.
John Dawson, Chief Executive Officer of Oxford Biomedica, said, “We are delighted to see the news today of the positive results from AstraZeneca for the COVID-19 vaccine, AZD1222. We are working hard to provide AstraZeneca with multiple large-scale batches of AZD1222 from our recently approved commercial manufacturing centre Oxbox. I am proud that Oxford Biomedica is part of the process that aims to bring normality back to many people around the world and I also personally want thank all our staff for their dedication and effort in production of the vaccine, whilst continuing to grow our core lentiviral vector business.”
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