Clinical Trials – AstraZeneca announce Vaccine 70% Efficacy.

It comes after a string of encouraging vaccine results in recent weeks, following late-stage trial readouts from Pfizer-BioNTech and Moderna.
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AstraZeneca announced that a combined interim analysis of late-stage studies showed that the COVID-19 candidate vaccine AZD1222 had an average efficacy of 70%, increasing to 90% for a regimen that included initial immunization with a half dose. The pooled data come from the COV002 phase 2/3 trial in the UK and the COV003 phase 3 study in Brazil.

According to AstraZeneca, the interim analysis included 11,636 participants and was based on a total of 131 cases of COVID-19, with the BBC reporting that there were 30 cases in people who received AZD1222. The company noted that the studies met their primary endpoint with an independent data safety monitoring board determining that the analysis showed protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine. In addition, there were no hospitalizations or severe cases of the disease reported in subjects receiving AZD1222.

AstraZeneca indicated that it will now prepare submission of the data to regulatory authorities, whilst it will seek an emergency-use listing from the World Health Organization allowing for accelerated availability in low-income countries. The drugmaker added that the full analysis of the interim results will be submitted for publication in a peer-reviewed journal.

Clinical studies of AZD1222 are also being conducted in the US, Japan, Russia, South Africa, Kenya and Latin America, with planned trials in other European and Asian countries, which will include a total of up 60,000 participants globally.

AstraZeneca said that it is “making rapid progress” on manufacturing AZD1222 with operations executive Pam Cheng noting that the company expects to have 200 million doses by the end of the year, with 700 million doses ready by the end of the first quarter of 2021. The drugmaker added that it aims to have a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis. Unlike mRNA vaccines being developed by Moderna and a partnership between Pfizer and BioNTech that require very cold temperatures for storage, AstraZeneca suggested that AZD1222 “can be stored, transported and handled at normal refrigerated conditions for at least six months and administered within existing healthcare settings.”

CEO Pascal Soriot commented “the vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval.” AZD1222, which was co-invented by the University of Oxford and its spin-out company Vaccitech, uses a replication-deficient chimpanzee viral vector and contains the genetic material of the SARS-CoV-2 virus spike protein.

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