Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine.
Lindsey R. Baden,Hana M. El Sahly,Brandon Essink,Karen L. Kotloff,Sharon E. Frey,Rick Novak,David Diemert,Stephen A. Spector,Nadine Rouphael,C. Buddy Creech,John W McGettigan,Shishir Khetan,Nathan Segall,Joel Solis,Adam Brosz,Carlos Fierro,Howard J. Schwartz,Kathleen M. Neuzil,Lawrence Corey,Peter B. Gilbert,Holly Janes,Dean Follmann,Mary A. Marovich,John R. Mascola,Laura Polakowski,Julie E. Ledgerwood,Barney S. Graham,Hamilton Bennett,Rolando Pajon,Conor Knightly,Brett Leav,Weiping Deng,Honghong Zhou,Shu Liang Han,Melanie Ivarsson,Jacqueline Miller,Tal Z Zaks +36 more
Reads0
Chats0
TLDR
The mRNA-1273 vaccine as discussed by the authors is a lipid nanoparticle-encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19.Abstract:
Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle-encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. Results The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P Conclusions The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.).read more
Citations
More filters
Journal ArticleDOI
Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection.
David S. Khoury,Deborah Cromer,Arnold Reynaldi,Timothy E. Schlub,Timothy E. Schlub,Adam K. Wheatley,Jennifer A Juno,Kanta Subbarao,Stephen J. Kent,Stephen J. Kent,Stephen J. Kent,James A. Triccas,Miles P. Davenport +12 more
TL;DR: It is shown that neutralization level is highly predictive of immune protection, and an evidence-based model of SARS-CoV-2 immune protection that will assist in developing vaccine strategies to control the future trajectory of the pandemic is provided.
Features, Evaluation and Treatment Coronavirus (COVID-19)
TL;DR: The effects of the epidemic caused by the new CoV has yet to emerge as the situation is quickly evolving, and world governments are at work to establish countermeasures to stem possible devastating effects.
Journal ArticleDOI
Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant.
Jamie Lopez Bernal,Nick Andrews,Charlotte Gower,Eileen Gallagher,Ruth Simmons,Simon Thelwall,Julia Stowe,Elise Tessier,Natalie Groves,Gavin Dabrera,Richard H. Myers,Colin Campbell,Gayatri Amirthalingam,Matt Edmunds,Maria Zambon,Kevin E. Brown,Susan Hopkins,Meera Chand,Mary Ramsay +18 more
TL;DR: The B.617.1.2 variant of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Coronavirus disease 2019 (Covid-19), has contributed to the development of the disease.
Journal ArticleDOI
BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting.
Noa Dagan,Noam Barda,Noam Barda,Noam Barda,Eldad Kepten,Oren Miron,Oren Miron,Shay Perchik,Mark A. Katz,Mark A. Katz,Mark A. Katz,Miguel A. Hernán,Marc Lipsitch,Ben Y. Reis,Ran D. Balicer,Ran D. Balicer +15 more
TL;DR: This study in a nationwide mass vaccination setting suggests that the BNT162b2 mRNA vaccine is effective for a wide range of Covid-19–related outcomes, a finding consistent with that of the randomized trial.
Journal ArticleDOI
Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia.
Denis Y. Logunov,Inna V. Dolzhikova,Dmitry V. Shcheblyakov,A. I. Tukhvatulin,Olga V. Zubkova,Alina S. Dzharullaeva,Anna V. Kovyrshina,Nadezhda L. Lubenets,Daria M. Grousova,Alina S. Erokhova,Andrei G. Botikov,Fatima M. Izhaeva,Olga Popova,Tatiana A Ozharovskaya,Ilias B Esmagambetov,Irina A Favorskaya,Denis I. Zrelkin,Daria V Voronina,Dmitry N. Shcherbinin,Alexander S. Semikhin,Yana V. Simakova,Elizaveta A. Tokarskaya,Daria A. Egorova,M M Shmarov,Natalia A. Nikitenko,Vladimir A. Gushchin,Elena A Smolyarchuk,Sergey Zyryanov,Sergei V. Borisevich,Boris S. Naroditsky,Alexander L. Gintsburg +30 more
TL;DR: Gam-COVID-Vac (Sputnik V) showed a good safety profile and induced strong humoral and cellular immune responses in participants in phase 1/2 clinical trials as discussed by the authors.
References
More filters
Journal ArticleDOI
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.
Fernando P. Polack,Stephen J. Thomas,Nicholas Kitchin,Judith Absalon,Alejandra Gurtman,Stephen Lockhart,John L. Perez,Gonzalo Pérez Marc,Edson D. Moreira,Cristiano Zerbini,Ruth Bailey,Kena A. Swanson,Satrajit Roychoudhury,Kenneth Koury,Ping Li,Warren Kalina,David A. Cooper,Robert W. Frenck,Laura L. Hammitt,Özlem Türeci,Haylene Nell,Axel Schaefer,Serhat Ünal,Dina B. Tresnan,Susan Mather,Philip R. Dormitzer,Ugur Sahin,Kathrin U. Jansen,William C. Gruber +28 more
TL;DR: A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older and safety over a median of 2 months was similar to that of other viral vaccines.
Journal ArticleDOI
Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.
Merryn Voysey,Clemens Sac.,Shabir A. Madhi,Lily Yin Weckx,P M Folegatti,Parvinder K. Aley,Brian Angus,Vicky L. Baillie,Shaun Barnabas,Q E Bhorat,S Bibi,Carmen Briner,P Cicconi,Andrea M. Collins,R Colin-Jones,Clare L. Cutland,Thomas C. Darton,Keertan Dheda,Duncan Cja.,Emary Krw.,Katie J. Ewer,Lee Fairlie,Saul N. Faust,Shuo Feng,Daniela M. Ferreira,Adam Finn,Anna Goodman,Catherine M. Green,Christopher A Green,Paul T. Heath,Christopher Hill,Helen Hill,Ian Hirsch,Hodgson Shc.,Allen Izu,S Jackson,D Jenkin,Joe Ccd.,S Kerridge,Anthonet Koen,Gaurav Kwatra,Rajeka Lazarus,Alison M. Lawrie,A Lelliott,Vincenzo Libri,Patrick J. Lillie,R Mallory,Mendes Ava.,Eveline Pipolo Milan,Angela M. Minassian,Alastair McGregor,Hazel Morrison,Y Mujadidi,Amit J Nana,P J O’Reilly,S D Padayachee,A Pittella,E Plested,Katrina M Pollock,M N Ramasamy,S Rhead,Alexandre Vargas Schwarzbold,Nisha Singh,Andrew Smith,R Song,Matthew D. Snape,Eduardo Sprinz,Rebecca K. Sutherland,R Tarrant,E. Thomson,M E Török,Mark Toshner,Turner Dpj.,Johan Vekemans,Tonya Villafana,Watson Mee.,C J Williams,Alexander D. Douglas,Hill Avs.,Teresa Lambe,Sarah C. Gilbert,Andrew J. Pollard +81 more
TL;DR: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials.
Journal ArticleDOI
An mRNA Vaccine against SARS-CoV-2 — Preliminary Report
Lisa A. Jackson,Evan J. Anderson,Nadine Rouphael,Paul C. Roberts,Mamodikoe Makhene,Rhea N. Coler,Michele Paine McCullough,James D. Chappell,Mark R. Denison,Laura J. Stevens,Andrea J. Pruijssers,Adrian B. McDermott,Britta Flach,Nicole A. Doria-Rose,Kizzmekia S. Corbett,Kaitlyn M. Morabito,Sijy O’Dell,Stephen D. Schmidt,Phillip A. Swanson,Marcelino Padilla,John R. Mascola,Kathleen M. Neuzil,Hamilton Bennett,Wellington Sun,Etza Peters,Mat Makowski,Jim Albert,Kaitlyn Cross,Wendy Buchanan,Rhonda Pikaart-Tautges,Julie E. Ledgerwood,Barney S. Graham,John H. Beigel +32 more
TL;DR: The mRNA-1273 vaccine induced anti-SARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified, which support further development of this vaccine.
Journal ArticleDOI
Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates.
Edward E. Walsh,Robert W. Frenck,Ann R. Falsey,Ann R. Falsey,Nicholas Kitchin,Judith Absalon,Alejandra Gurtman,Stephen Lockhart,Kathleen M. Neuzil,Mark J. Mulligan,Ruth Bailey,Kena A. Swanson,Ping Li,Kenneth Koury,Warren Kalina,David A. Cooper,Camila R. Fontes-Garfias,Pei Yong Shi,Özlem Türeci,Tompkins Kristin Rachael,Kirsten E. Lyke,Vanessa Raabe,Philip R. Dormitzer,Kathrin U. Jansen,Ugur Sahin,William C. Gruber +25 more
TL;DR: The safety and immunogenicity data from this U.S. phase 1 trial of two vaccine candidates in younger and older adults support the selection of BNT162b2 for advancement to a pivotal phase 2–3 safety and efficacy evaluation.
Journal ArticleDOI
Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis
TL;DR: Influenza vaccines can provide moderate protection against virologically confirmed influenza, but such protection is greatly reduced or absent in some seasons.
Related Papers (5)
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.
Fernando P. Polack,Stephen J. Thomas,Nicholas Kitchin,Judith Absalon,Alejandra Gurtman,Stephen Lockhart,John L. Perez,Gonzalo Pérez Marc,Edson D. Moreira,Cristiano Zerbini,Ruth Bailey,Kena A. Swanson,Satrajit Roychoudhury,Kenneth Koury,Ping Li,Warren Kalina,David A. Cooper,Robert W. Frenck,Laura L. Hammitt,Özlem Türeci,Haylene Nell,Axel Schaefer,Serhat Ünal,Dina B. Tresnan,Susan Mather,Philip R. Dormitzer,Ugur Sahin,Kathrin U. Jansen,William C. Gruber +28 more
Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.
Merryn Voysey,Clemens Sac.,Shabir A. Madhi,Lily Yin Weckx,P M Folegatti,Parvinder K. Aley,Brian Angus,Vicky L. Baillie,Shaun Barnabas,Q E Bhorat,S Bibi,Carmen Briner,P Cicconi,Andrea M. Collins,R Colin-Jones,Clare L. Cutland,Thomas C. Darton,Keertan Dheda,Duncan Cja.,Emary Krw.,Katie J. Ewer,Lee Fairlie,Saul N. Faust,Shuo Feng,Daniela M. Ferreira,Adam Finn,Anna Goodman,Catherine M. Green,Christopher A Green,Paul T. Heath,Christopher Hill,Helen Hill,Ian Hirsch,Hodgson Shc.,Allen Izu,S Jackson,D Jenkin,Joe Ccd.,S Kerridge,Anthonet Koen,Gaurav Kwatra,Rajeka Lazarus,Alison M. Lawrie,A Lelliott,Vincenzo Libri,Patrick J. Lillie,R Mallory,Mendes Ava.,Eveline Pipolo Milan,Angela M. Minassian,Alastair McGregor,Hazel Morrison,Y Mujadidi,Amit J Nana,P J O’Reilly,S D Padayachee,A Pittella,E Plested,Katrina M Pollock,M N Ramasamy,S Rhead,Alexandre Vargas Schwarzbold,Nisha Singh,Andrew Smith,R Song,Matthew D. Snape,Eduardo Sprinz,Rebecca K. Sutherland,R Tarrant,E. Thomson,M E Török,Mark Toshner,Turner Dpj.,Johan Vekemans,Tonya Villafana,Watson Mee.,C J Williams,Alexander D. Douglas,Hill Avs.,Teresa Lambe,Sarah C. Gilbert,Andrew J. Pollard +81 more
An mRNA Vaccine against SARS-CoV-2 — Preliminary Report
Lisa A. Jackson,Evan J. Anderson,Nadine Rouphael,Paul C. Roberts,Mamodikoe Makhene,Rhea N. Coler,Michele Paine McCullough,James D. Chappell,Mark R. Denison,Laura J. Stevens,Andrea J. Pruijssers,Adrian B. McDermott,Britta Flach,Nicole A. Doria-Rose,Kizzmekia S. Corbett,Kaitlyn M. Morabito,Sijy O’Dell,Stephen D. Schmidt,Phillip A. Swanson,Marcelino Padilla,John R. Mascola,Kathleen M. Neuzil,Hamilton Bennett,Wellington Sun,Etza Peters,Mat Makowski,Jim Albert,Kaitlyn Cross,Wendy Buchanan,Rhonda Pikaart-Tautges,Julie E. Ledgerwood,Barney S. Graham,John H. Beigel +32 more
Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates.
Edward E. Walsh,Robert W. Frenck,Ann R. Falsey,Ann R. Falsey,Nicholas Kitchin,Judith Absalon,Alejandra Gurtman,Stephen Lockhart,Kathleen M. Neuzil,Mark J. Mulligan,Ruth Bailey,Kena A. Swanson,Ping Li,Kenneth Koury,Warren Kalina,David A. Cooper,Camila R. Fontes-Garfias,Pei Yong Shi,Özlem Türeci,Tompkins Kristin Rachael,Kirsten E. Lyke,Vanessa Raabe,Philip R. Dormitzer,Kathrin U. Jansen,Ugur Sahin,William C. Gruber +25 more
Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19.
Jerald C. Sadoff,Glenda Gray,An Vandebosch,Vicky Cardenas,Georgi Shukarev,Beatriz Grinsztejn,Paul A. Goepfert,Carla Truyers,Hein Fennema,Bart Spiessens,Kim Offergeld,Gert Scheper,Kimberly L Taylor,Merlin L. Robb,John J. Treanor,Dan H. Barouch,Jeffrey J. Stoddard,Martin Ryser,Mary A. Marovich,Kathleen M. Neuzil,Lawrence Corey,Nancy Cauwenberghs,Tamzin Tanner,Karin Hardt,Javier Ruiz-Guiñazú,Mathieu Le Gars,Hanneke Schuitemaker,Johan Van Hoof,Frank Struyf,Macaya Douoguih +29 more