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10.1056/NEJMoa2102214

http://scihub22266oqcxt.onion/10.1056/NEJMoa2102214
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33725432!7993410!33725432
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suck abstract from ncbi


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pmid33725432      N+Engl+J+Med 2021 ; 384 (20): 1885-1898
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  • Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B 1 351 Variant #MMPMID33725432
  • Madhi SA; Baillie V; Cutland CL; Voysey M; Koen AL; Fairlie L; Padayachee SD; Dheda K; Barnabas SL; Bhorat QE; Briner C; Kwatra G; Ahmed K; Aley P; Bhikha S; Bhiman JN; Bhorat AE; du Plessis J; Esmail A; Groenewald M; Horne E; Hwa SH; Jose A; Lambe T; Laubscher M; Malahleha M; Masenya M; Masilela M; McKenzie S; Molapo K; Moultrie A; Oelofse S; Patel F; Pillay S; Rhead S; Rodel H; Rossouw L; Taoushanis C; Tegally H; Thombrayil A; van Eck S; Wibmer CK; Durham NM; Kelly EJ; Villafana TL; Gilbert S; Pollard AJ; de Oliveira T; Moore PL; Sigal A; Izu A
  • N Engl J Med 2021[May]; 384 (20): 1885-1898 PMID33725432show ga
  • BACKGROUND: Assessment of the safety and efficacy of vaccines against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in different populations is essential, as is investigation of the efficacy of the vaccines against emerging SARS-CoV-2 variants of concern, including the B.1.351 (501Y.V2) variant first identified in South Africa. METHODS: We conducted a multicenter, double-blind, randomized, controlled trial to assess the safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) in people not infected with the human immunodeficiency virus (HIV) in South Africa. Participants 18 to less than 65 years of age were assigned in a 1:1 ratio to receive two doses of vaccine containing 5x10(10) viral particles or placebo (0.9% sodium chloride solution) 21 to 35 days apart. Serum samples obtained from 25 participants after the second dose were tested by pseudovirus and live-virus neutralization assays against the original D614G virus and the B.1.351 variant. The primary end points were safety and efficacy of the vaccine against laboratory-confirmed symptomatic coronavirus 2019 illness (Covid-19) more than 14 days after the second dose. RESULTS: Between June 24 and November 9, 2020, we enrolled 2026 HIV-negative adults (median age, 30 years); 1010 and 1011 participants received at least one dose of placebo or vaccine, respectively. Both the pseudovirus and the live-virus neutralization assays showed greater resistance to the B.1.351 variant in serum samples obtained from vaccine recipients than in samples from placebo recipients. In the primary end-point analysis, mild-to-moderate Covid-19 developed in 23 of 717 placebo recipients (3.2%) and in 19 of 750 vaccine recipients (2.5%), for an efficacy of 21.9% (95% confidence interval [CI], -49.9 to 59.8). Among the 42 participants with Covid-19, 39 cases (95.1% of 41 with sequencing data) were caused by the B.1.351 variant; vaccine efficacy against this variant, analyzed as a secondary end point, was 10.4% (95% CI, -76.8 to 54.8). The incidence of serious adverse events was balanced between the vaccine and placebo groups. CONCLUSIONS: A two-dose regimen of the ChAdOx1 nCoV-19 vaccine did not show protection against mild-to-moderate Covid-19 due to the B.1.351 variant. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov number, NCT04444674; Pan African Clinical Trials Registry number, PACTR202006922165132).
  • |*Immunogenicity, Vaccine[MESH]
  • |*SARS-CoV-2[MESH]
  • |Adenoviridae[MESH]
  • |Adolescent[MESH]
  • |Adult[MESH]
  • |Antibodies, Neutralizing/*blood/physiology[MESH]
  • |COVID-19 Serological Testing[MESH]
  • |COVID-19 Vaccines/administration & dosage/adverse effects/*immunology[MESH]
  • |COVID-19/epidemiology/immunology/*prevention & control[MESH]
  • |ChAdOx1 nCoV-19[MESH]
  • |Double-Blind Method[MESH]
  • |Humans[MESH]
  • |Middle Aged[MESH]
  • |South Africa[MESH]
  • |T-Lymphocytes/physiology[MESH]
  • |Treatment Failure[MESH]
  • |Vaccine Potency[MESH]


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