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Durability of Protection Against Symptomatic COVID-19 Among Participants of the mRNA-1273 SARS-CoV-2 Vaccine Trial
research-article
Author(s):
Dan-Yu Lin , PhD
1
,
,
Lindsey R. Baden , MD
2 ,
Hana M. El Sahly , MD
3 ,
Brandon Essink , MD
4 ,
Kathleen M. Neuzil , MD
5 ,
Lawrence Corey , MD
6 ,
Jacqueline Miller , MD
7
Publication date (Electronic):
8 June 2022
Journal:
JAMA Network Open
Publisher:
American Medical Association
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Abstract
This cohort study assesses the durability of protection against symptomatic COVID-19 among participants of the mRNA-1273 SARS-CoV-2 (Moderna) vaccine trial.
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Most cited references7
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Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine
Lindsey Baden, Hana El Sahly, Brandon Essink … (2020)
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<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. 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.)
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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months
Background BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein. BNT162b2 is highly efficacious against coronavirus disease 2019 (Covid-19) and is currently approved, conditionally approved, or authorized for emergency use worldwide. At the time of initial authorization, data beyond 2 months after vaccination were unavailable. Methods In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy trial, we randomly assigned 44,165 participants 16 years of age or older and 2264 participants 12 to 15 years of age to receive two 30-μg doses, at 21 days apart, of BNT162b2 or placebo. The trial end points were vaccine efficacy against laboratory-confirmed Covid-19 and safety, which were both evaluated through 6 months after vaccination. Results BNT162b2 continued to be safe and have an acceptable adverse-event profile. Few participants had adverse events leading to withdrawal from the trial. Vaccine efficacy against Covid-19 was 91.3% (95% confidence interval [CI], 89.0 to 93.2) through 6 months of follow-up among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated. There was a gradual decline in vaccine efficacy. Vaccine efficacy of 86 to 100% was seen across countries and in populations with diverse ages, sexes, race or ethnic groups, and risk factors for Covid-19 among participants without evidence of previous infection with SARS-CoV-2. Vaccine efficacy against severe disease was 96.7% (95% CI, 80.3 to 99.9). In South Africa, where the SARS-CoV-2 variant of concern B.1.351 (or beta) was predominant, a vaccine efficacy of 100% (95% CI, 53.5 to 100) was observed. Conclusions Through 6 months of follow-up and despite a gradual decline in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing Covid-19. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728 .)
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Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase
Hana El Sahly, Lindsey Baden, Brandon Essink … (2021)
Background At interim analysis in a phase 3, observer-blinded, placebo-controlled clinical trial, the mRNA-1273 vaccine showed 94.1% efficacy in preventing coronavirus disease 2019 (Covid-19). After emergency use of the vaccine was authorized, the protocol was amended to include an open-label phase. Final analyses of efficacy and safety data from the blinded phase of the trial are reported. Methods We enrolled volunteers who were at high risk for Covid-19 or its complications; participants were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo, 28 days apart, at 99 centers across the United States. 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 the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The data cutoff date was March 26, 2021. Results The trial enrolled 30,415 participants; 15,209 were assigned to receive the mRNA-1273 vaccine, and 15,206 to receive placebo. More than 96% of participants received both injections, 2.3% had evidence of SARS-CoV-2 infection at baseline, and the median follow-up was 5.3 months in the blinded phase. Vaccine efficacy in preventing Covid-19 illness was 93.2% (95% confidence interval [CI], 91.0 to 94.8), with 55 confirmed cases in the mRNA-1273 group (9.6 per 1000 person-years; 95% CI, 7.2 to 12.5) and 744 in the placebo group (136.6 per 1000 person-years; 95% CI, 127.0 to 146.8). The efficacy in preventing severe disease was 98.2% (95% CI, 92.8 to 99.6), with 2 cases in the mRNA-1273 group and 106 in the placebo group, and the efficacy in preventing asymptomatic infection starting 14 days after the second injection was 63.0% (95% CI, 56.6 to 68.5), with 214 cases in the mRNA-1273 group and 498 in the placebo group. Vaccine efficacy was consistent across ethnic and racial groups, age groups, and participants with coexisting conditions. No safety concerns were identified. Conclusions The mRNA-1273 vaccine continued to be efficacious in preventing Covid-19 illness and severe disease at more than 5 months, with an acceptable safety profile, and protection against asymptomatic infection was observed. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427 .)
Author and article information
Journal
Journal ID (nlm-ta): JAMA Netw Open
Journal ID (iso-abbrev): JAMA Netw Open
Title:
JAMA Network Open
Publisher:
American Medical Association
ISSN
(Electronic):
2574-3805
Publication date
(Electronic):
8
June
2022
Publication date Collection:
June
2022
Publication date PMC-release: 8
June
2022
Volume: 5
Issue: 6
Electronic Location Identifier: e2215984
Affiliations
Author notes
Article Information
Open Access: This is an open access article distributed under the terms of the
CC-BY License. © 2022 Lin DY et al.
JAMA Network Open.
Corresponding Author: Dan-Yu Lin, PhD, Department of Biostatistics, University of North Carolina, Chapel
Hill, NC 27599-7420 (
lin@
123456bios.unc.edu
).
Author Contributions: Drs Baden and Miller had full access to all the data in the study and take responsibility
for the integrity of the data and the accuracy of the data analysis.
Conflict of Interest Disclosures: Dr Baden reported receiving grants from the National Institute of Allergy and Infectious
Disease of the National Institutes of Health (NIAID/NIH) during the conduct of the
study and being involved in HIV and COVID vaccine clinical trials conducted in collaboration
with the NIH, HIV Vaccine Trials Network, COVID Vaccine Prevention Network, International
AIDS Vaccine Initiative, Crucell/Janssen, Moderna, Military HIV Research Program,
Gates Foundation, and the Ragon Institute. Dr El Sahly reported receiving grants from
NIAID/NIH for research funding during the conduct of the study. Dr Neuzil reported
receiving grants from Pfizer to conduct clinical trials of COVID-19 vaccines and grants
from NIH to participate in overall organization of COVID-19 vaccine trials and for
participation in vaccine trials during the conduct of the study. Dr Corey reported
receiving grants from NIH/NIAID during the conduct of the study. Dr Miller reported
being employed by Moderna during the conduct of the study and having stock options
and receiving grants from Moderna outside the submitted work. No other disclosures
were reported.
Funding/Support: This work was supported by grant R01 AI029168 from the National Institutes of Health
(Dr Lin).
Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management,
analysis, and interpretation of the data; preparation, review, or approval of the
manuscript; and decision to submit the manuscript for publication.
Group information: The COVE Study Group members are listed in
Supplement 2.
Article
Publisher ID: zld220112DOI: 10.1001/jamanetworkopen.2022.15984
PMC ID: 9178430
PubMed ID: 35675078
SO-VID: cfd75b75-a06b-4b7c-94ed-16cf23b59847
Copyright © Copyright 2022 Lin DY et al.
JAMA Network Open.
License:
This is an open access article distributed under the terms of the CC-BY License.
History
Date
received
: 13
February
2022
Date
accepted
: 21
April
2022
Categories
Subject:
Research
Subject:
Research Letter
Subject:
Online Only
Subject:
Infectious Diseases
Data availability: