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Good vaccine news in US

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AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/astrazeneca-us-vaccine-trial-met-primary-endpoint.html https://clinicaltrials.gov/ct2/show/NCT04516746?term=NCT04516746&draw=2&rank=1 Interim safety and efficacy analysis N = 32,449 2:1 randomisation of vaccine to placebo Accruing 141 symptomatic cases of COVID-19 Statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 100% efficacy at preventing severe disease and hospitalisation Vaccine efficacy was consistent across ethnicity and age Aged 65 years and over, vaccine efficacy was 80% The vaccine was well tolerated Favourable reactogenicity and overall safety Independent data safety monitoring board (DSMB) identified no safety concerns DSMB conducted a specific review of thrombotic events, as well as cerebral venous sinus thrombosis (CVST) with the assistance of an independent neurologist DSMB found no increased risk of thrombosis or events characterised by thrombosis, n = 21,583, receiving at least one dose of the vaccine The specific search for CVST found no events in this trial 79% white/Caucasian 8% black/African American 4% native American 4% Asian 22% of participants were Hispanic. Two doses administered, four week interval Extended interval of up to 12 weeks demonstrated greater efficacy Supported by immunogenicity data This evidence suggests administration of the second dose with an interval Longer interval could further increase efficacy and accelerates the number of people who can receive their first dose Stored, transported and handled at normal refrigerated conditions 2-8 degrees Celsius or 36-46 degrees Fahrenheit, for at least six months Counter argument https://www.nih.gov/news-events/news-releases/niaid-statement-astrazeneca-vaccine Concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. Food and Drug Administration and Centers for Disease Control and Prevention to decide. After thorough review of the data by independent advisory committees

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