Durability of Protection Against Symptomatic COVID-19 Among Participants of the mRNA-1273 SARS-CoV-2 Vaccine Trial | Infectious Diseases | JN Learning | AMA Ed Hub [Skip to Content]
[Skip to Content Landing]

Durability of Protection Against Symptomatic COVID-19 Among Participants of the mRNA-1273 SARS-CoV-2 Vaccine Trial

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

Evaluating the durability of protection afforded by COVID-19 vaccines is a public health priority, with the results needed to inform policies around booster vaccinations as well as those around nonpharmaceutical interventions. We considered the mRNA-1273 P301 cohort study, which is an ongoing phase 3, randomized, placebo-controlled trial of 30 415 US adults to evaluate the efficacy and safety of the mRNA-1273 SARS-CoV-2 (Moderna) vaccine.1,2 The vaccine efficacy (VE) against symptomatic COVID-19 was estimated at 94.1% at interim analysis and at 93.2% at completion of the blinded phase.1,2 Comparison of these 2 estimates would suggest a slight waning of VE. However, this comparison is not sensitive enough to detect the true degree of waning, because the VE estimate was obtained under the assumption that VE is constant during the period of analysis and thus represents a mean of the time-varying vaccine effect over a broad study period, weighted by when the event occurs, rather than the VE at the end of the study period.

Sign in to take quiz and track your certificates

Buy This Activity

CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Accepted for Publication: April 21, 2022.

Published: June 8, 2022. doi:10.1001/jamanetworkopen.2022.15984

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@bios.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.

Concept and design: Lin, Baden, El Sahly, Neuzil, Corey, Miller.

Acquisition, analysis, or interpretation of data: Lin, Baden, El Sahly, Essink, Neuzil.

Drafting of the manuscript: Lin, Baden.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Lin, Essink.

Obtained funding: Baden, El Sahly, Corey.

Administrative, technical, or material support: Baden.

Supervision: Baden, El Sahly, Essink, Corey, Miller.

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.

Additional Information: Moderna provided the data for this study to the COVID-19 Prevention Network.

References
1.
Baden  LR , El Sahly  HM , Essink  B ,  et al; COVE Study Group.  Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine.   N Engl J Med. 2021;384(5):403-416. doi:10.1056/NEJMoa2035389 PubMedGoogle ScholarCrossref
2.
El Sahly  HM , Baden  LR , Essink  B ,  et al; COVE Study Group.  Efficacy of the mRNA-1273 SARS-CoV-2 vaccine at completion of blinded phase.   N Engl J Med. 2021;385(19):1774-1785. doi:10.1056/NEJMoa2113017 PubMedGoogle ScholarCrossref
3.
Lin  DY , Gu  Y , Zeng  D , Janes  HE , Gilbert  PB .  Evaluating vaccine efficacy against severe acute respiratory syndrome coronavirus 2 infection.   Clin Infect Dis. 2022;74(3):544-552. doi:10.1093/cid/ciab630PubMedGoogle ScholarCrossref
4.
Lin  DY , Zeng  D , Gilbert  PB .  Evaluating the long-term efficacy of coronavirus disease 2019 (COVID-19) vaccines.   Clin Infect Dis. 2021;73(10):1927-1939. doi:10.1093/cid/ciab226 PubMedGoogle ScholarCrossref
5.
Fintzi  J , Follmann  D .  Assessing vaccine durability in randomized trials following placebo crossover.   Stat Med. 2021;40(27):5983-6007. doi:10.1002/sim.9001 PubMedGoogle ScholarCrossref
6.
Thomas  SJ , Moreira  ED  Jr , Kitchin  N ,  et al; C4591001 Clinical Trial Group.  Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine through 6 months.   N Engl J Med. 2021;385(19):1761-1773. doi:10.1056/NEJMoa2110345 PubMedGoogle ScholarCrossref
Want full access to the AMA Ed Hub?
After you sign up for AMA Membership, make sure you sign in or create a Physician account with the AMA in order to access all learning activities on the AMA Ed Hub
Buy this activity
Close
Want full access to the AMA Ed Hub?
After you sign up for AMA Membership, make sure you sign in or create a Physician account with the AMA in order to access all learning activities on the AMA Ed Hub
Buy this activity
Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close

Name Your Search

Save Search
Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Close

Lookup An Activity

or

Close

My Saved Searches

You currently have no searches saved.

Close

My Saved Courses

You currently have no courses saved.

Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close