An mRNA Vaccine against SARS-CoV-2 — Preliminary Report
Authors: Wendy Buchanan
Sydney Biccum
Joyce Benoit
Hollie Macenczak
Alicia Widge
Felicia Glover
Stella Lee
Kevin Carlton
Eun Sung Yang
Lisa Macoy
John R Mascola
mRNA-1273 Study Group
Barbara A Carste
Oliver Smith
Jianguo Xu
Xiaotao Lu
Matthew Collins
Nedim Emil Altaras
Kathleen Stephens
Francine Dyer
Wellington Sun
Karen Wilkinson
Peggy Kettle
Brett Leav
Rebecca A Gillespie
Stephanie Pimienta
Helen Chu
Jessica Traenkner
Susan Rogers
Jim Albert
Ghina Alaaeddine
Xuemin Chen
David Skatula
Roxanne Erolin
Mary Bower
Marcelino Padilla
Maya B Dunstan
Ashley Tippett
Mehgan Teherani
Mark K Louder
Hallie Phillips
Evan J Anderson
Erin Scherer
Jennifer Nielsen
Maya Dunstan
Kizzmekia S Corbett
Kathryn Zaks
Mark R Denison
Sijy O&#x27;Dell
Catherine Luke
Laurel Bristow
Yongxian Xu
Nicole A Doria-Rose
Martin Gaudinski
Elisa Sindall
Pratap Kunwar
Mohammed Elsafy
Carol Kao
Laura Clegg
Marjorie Hurley
Paul C Roberts
Jorge Mejia-Galvis
Andreas Camacho-Gonzalez
Eli Sendra
Susan L Baldwin
Lingshu Wang
Sean Todd
Andrea Carfi
Lisa Harewood
Cassandra Karcs
Larry Anderson
Srilatha Edupuganti
Kaitlyn M Morabito
Youssef Saklawi
Theda Gibson
Adrian B McDermott
Brittany Robinson
Ana Drobeniuc
Evan Cross
Stephen D Schmidt
Sasha E Larsen
Bob C Lin
Adrian McDermott
Seema Nayak
Hui-Mien Hsiao
Hyung Koo
Amer Bechnak
Ranjodh Gill
James M Ferrenberg
Jana Ffitch
Binh Hoang
Rhea N Coler
Sonnie Kim
Brandi Johnson
James D Chappell
Barney S Graham
Rachael Burganowski
David Ho
Phillip A Swanson 2nd
Brian Granger
Kaitlyn Cross
Rodrigo Laureano
Richard L Bearden 2nd
John H Beigel
Jae Arega
Joe Choe
Erika Kiniry
Dongli Wang
Britta Flach
Gordon Bernard
Marina Lee
Seyhan Boyoglu-Barnum
Susan Lasicka
Teresa Ball
Barbara Carste
Wensheng Li
Amy Muchinsky
Michael Witte
Colleen Kelley
Tal Zaks
Tiffany Pecor
Heather Beseler
Terra Jean Winter
Janice Suyehira
Valerie A Reese
Laura J Stevens
Laila Hussaini
Matthew Nguyen
Michele Paine McCullough
Colin Fields
Rolando Pajon
Satoshi Kamidani
Christina Rostad
Mat Makowski
Kathleen M Neuzil
Juton Winston
Rhonda Pikaart-Tautges
Alexis Ahonen
Lee Barr
Lisa A Jackson
Andrea J Pruijssers
Laura Novik
Amy Sherman
Amber Samuel
Nadine Rouphael
Bryan Berube
De Vona Lang
Nadine G Rouphael
Yi Zhang
Ingelise Gordon
Ava Manokian
Michele P McCullough
Hamilton Bennett
G Osinski
Amanda Panepento
Mamodikoe Makhene
Inci Yildirim
Julie E Ledgerwood
Tia Hughes
Etza Peters
Varun Phadke
John Dunn
Cynthia Whitney
Journal: New England Journal of Medicine (2020)
Discipline: CLINICAL MEDICINE
Keywords: SARS-CoV-2; vaccine development; mRNA-1273; phase 1 trial; dose-escalation
Affiliations: From Kaiser Permanente Washington Health Research Institute (L.A.J.) and the Center for Global Infectious Disease Research (CGIDR), Seattle Children’s Research Institute (R.N.C.) — both in Seattle; the Department of Medicine, Center for Childhood Infections and Vaccines (CCIV) of Children’s Healthcare of Atlanta and Emory University Department of Pediatrics, Atlanta (E.J.A., E.P.), and Hope Clinic, Department of Medicine, Emory University School of Medicine, Decatur (N.G.R., M.P.M.) — both in Georgia;...

Abstract:  Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in late 2019 and spread globally, prompting an international effort to accelerate development of a vaccine. The candidate vaccine mRNA-1273 encodes the stabilized prefusion SARS-CoV-2 spike protein. Methods: We conducted a phase 1, dose-escalation, open-label trial including 45 healthy adults, 18 to 55 years of age, who received two vaccinations, 28 days apart, with mRNA-1273 in a dose of 25 μg, 100 μg, or 250 μg. There were 15 participants in each dose group. Results: After the first vaccination, antibody responses were higher with higher dose (day 29 enzyme-linked immunosorbent assay anti-S-2P antibody geometric mean titer [GMT], 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group). After the second vaccination, the titers increased (day 57 GMT, 299,751, 782,719, and 1,192,154, respectively). After the second vaccination, serum-neutralizing activity was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum specimens. Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events. Conclusions: The mRNA-1273 vaccine induced anti-SARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified. These findings support further development of this vaccine. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number, NCT04283461). 

Retracted: No

PubPeer comments:
 Can author double check the ethnicity in the Table 1? The sums are beyond 15. ![file] In addition, Figure 2D (the live virus PRNT80). If one looks closely, there are 15 and 17 points for 25ug and 100ug groups. It should be 13 and 14 points according to Table 2. ![file] , 
 I think that for Table 1, the Unknown and Hispanic or Latino rows are switched. it makes more sense for the last row to be the Unknown group and excluded from the total numbers for each study group. As for Figure 2D, I agree - it appears that the plot does not match the data in Table 2. , 
 Ethnicity (Hispanic or Latino) is a separate axis from race. In the tables, the numbers for race total correctly in each column. So table 1 looks fine. ,