{"corpus_id":235697707,"paper_sha":"a2e0b83a36ff325f574c4cb456c956ca36f99750","doi":"10.1056/NEJMoa2107659","arxiv_id":null,"pmid":null,"pmcid":"PMC8262625","mag_id":null,"dblp_id":null,"acl_id":null,"title":"Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine","year":2021,"publication_date":"2021-06-30","venue":"New England Journal of Medicine","journal":{"name":"New England Journal of Medicine","pages":null,"volume":null},"journal_issn":null,"journal_title":null,"publication_types":[],"pubmed_pub_types":null,"s2_fields_of_study":["Medicine"],"reference_count":18,"citation_count":758,"influential_citation_count":41,"is_open_access":true,"arxiv_categories":null,"arxiv_license":null,"arxiv_journal_ref":null,"mesh_headings":null,"chemicals":null,"comments_corrections":null,"source_flags":1,"s2_open_access_pdf_url":"https://pure.qub.ac.uk/files/245028826/nejmoa2107659.pdf","s2_open_access_landing_url":"https://www.semanticscholar.org/paper/a2e0b83a36ff325f574c4cb456c956ca36f99750","s2_open_access_license":"other-oa","s2_open_access_status":"GREEN","pmc_open_access_pdf_url":null,"pmc_open_access_landing_url":null,"pmc_open_access_license":null,"pmc_open_access_status":null,"unpaywall_open_access_pdf_url":null,"unpaywall_open_access_landing_url":null,"unpaywall_open_access_license":null,"unpaywall_open_access_status":null,"abstract":"BACKGROUND: Early clinical data from studies of the NVX-CoV2373 vaccine (Novavax), a recombinant nanoparticle vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that contains the full-length spike glycoprotein of the prototype strain plus Matrix-M adjuvant, showed that the vaccine was safe and associated with a robust immune response in healthy adult participants. Additional data were needed regarding the efficacy, immunogenicity, and safety of this vaccine in a larger population. METHODS: In this phase 3, randomized, observer-blinded, placebo-controlled trial conducted at 33 sites in the United Kingdom, we assigned adults between the ages of 18 and 84 years in a 1:1 ratio to receive two intramuscular 5-µg doses of NVX-CoV2373 or placebo administered 21 days apart. The primary efficacy end point was virologically confirmed mild, moderate, or severe SARS-CoV-2 infection with an onset at least 7 days after the second injection in participants who were serologically negative at baseline. RESULTS: A total of 15,187 participants underwent randomization, and 14,039 were included in the per-protocol efficacy population. Of the participants, 27.9% were 65 years of age or older, and 44.6% had coexisting illnesses. Infections were reported in 10 participants in the vaccine group and in 96 in the placebo group, with a symptom onset of at least 7 days after the second injection, for a vaccine efficacy of 89.7% (95% confidence interval [CI], 80.2 to 94.6). No hospitalizations or deaths were reported among the 10 cases in the vaccine group. Five cases of severe infection were reported, all of which were in the placebo group. A post hoc analysis showed an efficacy of 86.3% (95% CI, 71.3 to 93.5) against the B.1.1.7 (or alpha) variant and 96.4% (95% CI, 73.8 to 99.5) against non-B.1.1.7 variants. Reactogenicity was generally mild and transient. The incidence of serious adverse events was low and similar in the two groups. CONCLUSIONS: A two-dose regimen of the NVX-CoV2373 vaccine administered to adult participants conferred 89.7% protection against SARS-CoV-2 infection and showed high efficacy against the B.1.1.7 variant. (Funded by Novavax; EudraCT number, 2020-004123-16.).","claims":[{"public_id":"cl_53346559bbbb2577468422b2f4fea248","status":"active","text":"A phase 3 randomized observer-blinded placebo-controlled trial at 33 United Kingdom sites assigned adults aged 18 to 84 years in a 1:1 ratio to receive two intramuscular 5-µg doses of NVX-CoV2373 vaccine or placebo 21 days apart.","confidence":0.98,"contributors":[{"id":35,"public_id":"b2adb6bfad","public_label":"Anonymous (b2adb6bfad)","roles":["extraction"],"url":"https://sah.borca.ai/u/b2adb6bfad"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_53346559bbbb2577468422b2f4fea248"},{"public_id":"cl_8cf0695911aa754b7c70f93874726d1f","status":"active","text":"NVX-CoV2373 vaccine showed 89.7% vaccine efficacy against virologically confirmed mild, moderate, or severe SARS-CoV-2 infection, with 10 infections in the vaccine group and 96 in the placebo group after the second injection.","confidence":0.98,"contributors":[{"id":35,"public_id":"b2adb6bfad","public_label":"Anonymous (b2adb6bfad)","roles":["extraction"],"url":"https://sah.borca.ai/u/b2adb6bfad"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_8cf0695911aa754b7c70f93874726d1f"},{"public_id":"cl_a6f21557040c915dd5f26f4ccc821cab","status":"active","text":"No hospitalizations or deaths occurred among vaccine-group cases, and all five severe infections occurred in the placebo group.","confidence":0.96,"contributors":[{"id":35,"public_id":"b2adb6bfad","public_label":"Anonymous (b2adb6bfad)","roles":["extraction"],"url":"https://sah.borca.ai/u/b2adb6bfad"},{"id":2,"public_id":"4715169a40","public_label":"AK (4715169a40)","roles":["review"],"url":"https://sah.borca.ai/u/4715169a40"},{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["review"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_a6f21557040c915dd5f26f4ccc821cab"},{"public_id":"cl_961c99d020b2673af351eec48bf9a606","status":"active","text":"Post hoc analysis estimated 86.3% efficacy against the B.1.1.7 variant and 96.4% efficacy against non-B.1.1.7 variants.","confidence":0.95,"contributors":[{"id":35,"public_id":"b2adb6bfad","public_label":"Anonymous (b2adb6bfad)","roles":["extraction"],"url":"https://sah.borca.ai/u/b2adb6bfad"},{"id":2,"public_id":"4715169a40","public_label":"AK 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