drj logo
  • This field is for validation purposes and should be left unchanged.

Already have an account? Log in

drj logo

Welcome to DRJ

Already registered user? Please login here

Login Form

Register
Forgot password? Click here to reset

Create new account
(it's completely free). Subscribe

Skip to content
Disaster Recovery Journal
  • EN ESPAÑOL
  • SIGN IN
  • SUBSCRIBE
  • THE JOURNAL
    • Young Professional Spotlight
    • Career Spotlight
    • Article Submission
    • Digital Edition
    • DRJ Annual Resource Directories
    • Article Archives
  • EVENTS
    • Fall 2021
    • Call for Papers – Fall 2021
    • DRJ Town Hall Meetings
    • Other Industry Events
    • Schedule & Archive
  • WEBINARS
    • Upcoming
    • On Demand
  • MENTOR PROGRAM
  • DRJ ACADEMY
  • RESOURCES
    • White Papers
    • DR Rules and Regs
    • Industry Groups
    • Business Directory
    • Business Resilience Decoded
    • DRJ Glossary of Business Continuity Terms
  • ABOUT
    • Board and Committees
      • Executive Council Members
      • Editorial Advisory Board
      • Career Development Committee
      • FAQs Committee
      • Web Committee
      • Glossary Committee
      • Rules and Regulations Committee
  • Podcast

Moderna Highlights Publication of Antibody Persistence Data of its COVID-19 Vaccine out to 6 Months in the New England Journal of Medicine

by DRJ Editorial Team | April 7, 2021 | | 0 comments

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today highlighted the publication of antibody persistence data out to 6 months following the second dose of the Moderna COVID-19 Vaccine in The New England Journal of Medicine.

“We are pleased that this new data shows antibody persistence through 6 months following the second dose of our COVID-19 vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna. “This gives us further confidence in the protection afforded by our COVID-19 vaccine. We remain committed to continuing to address the COVID-19 pandemic.”

This study analyzed 33 healthy adult participants in the NIH-led Phase 1 study of Moderna’s COVID-19 Vaccine at 6 months following the second 100 μg dose (day 209). As detected by three distinct serologic assays, antibodies elicited by the Moderna COVID-19 vaccine persisted through 6 months after the second dose. Antibody decay was estimated using two approaches and was consistent with published observations of convalescent patients with COVID-19 through 8 months after symptom onset.

Studies monitoring immune responses beyond 6 months are ongoing. Out of an abundance of caution, Moderna is also pursuing a clinical development strategy against emerging variants. Additionally, NIAID, part of the National Institutes of Health (NIH), will conduct a Phase 1 clinical trial to assess the monovalent and multivalent modified mRNA-1273 vaccines as a primary series in naïve individuals and as a booster vaccine in those previously vaccine with mRNA-1273.

About the Moderna COVID-19 Vaccine

The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the National Institutes of Health (NIH) on February 24, 2020, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 2020, 63 days from sequence selection to Phase 1 study dosing. On May 12, 2020, the U.S. FDA granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, 2020, the first participants in each age cohort were dosed in the Phase 2 study of the vaccine. On July 8, 2020, the Phase 2 study completed enrollment.

Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29, 2020 in The New England Journal of Medicine. On November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On November 30, 2020, the Company also announced that it filed for Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency. On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has also received authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore and Qatar. Additional authorizations are currently under review in other countries and by the World Health Organization.

The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) is supporting the continued research and development of the Company’s COVID-19 vaccine development efforts with federal funding under contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to purchase supply of mRNA-1273 under U.S. Department of Defense contract no. W911QY-20-C-0100.

AUTHORIZED USE

Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

IMPORTANT SAFETY INFORMATION

  • Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine.
  • Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID-19 Vaccine. Monitor Moderna COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).
  • Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the Moderna COVID-19 Vaccine.
  • The Moderna COVID-19 Vaccine may not protect all vaccine recipients.
  • Adverse reactions reported in a clinical trial following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site.
  • Severe allergic reactions, including anaphylaxis, have been reported following administration of the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials.
  • Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Data are not available to assess the effects of Moderna COVID-19 Vaccine on the breastfed infant or on milk production/excretion.
  • There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Moderna COVID-19 Vaccine should receive a second dose of Moderna COVID-19 Vaccine to complete the vaccination series.
  • Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID-19 Vaccine.
  • Vaccination providers must complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words “Moderna COVID-19 Vaccine EUA” in the description section of the report.

Click for Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information for more information.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the Company’s development of a vaccine (mRNA-1273) to protect against the SARS-CoV-2 virus, which causes COVID-19, the duration of such protection, and the Company’s strategy for developing vaccines in response to variants of the SARS-CoV-2 virus. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; the Moderna COVID-19 Vaccine may prove less effective against variants of the SARS-CoV-2 virus, or the Company may be unsuccessful in developing future versions of its vaccine against these variants; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or additional emergency use authorization applications may be filed in various jurisdictions and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.

Contacts

Moderna Contacts:

Media:
Colleen Hussey

Director, Corporate Communications

617-335-1374

Colleen.Hussey@modernatx.com

Investors:
Lavina Talukdar

Senior Vice President & Head of Investor Relations

617-209-5834

Lavina.Talukdar@modernatx.com

Recent Posts

  • Download Your Planning Templates
  • They Called Me ‘The Queen of Doom’
  • Business Continuity as a Business Strategy
  • AlertMedia Improves Emergency Management with the Launch of Event Pages: Connecting People with Critical Information in Real-Time
  • Disaster Recovery Planning in a VM Operating Environment

Recent Comments

    Archives

    • December 2020 (1)
    • October 2020 (1)
    • August 2020 (1)
    • January 2020 (1)
    • November 2019 (9)
    • October 2019 (8)
    • September 2019 (8)
    • August 2019 (17)
    • July 2019 (77)
    • June 2019 (92)
    • May 2019 (128)
    • April 2019 (109)
    • March 2019 (80)
    • February 2019 (106)
    • January 2019 (102)
    • December 2018 (96)
    • November 2018 (131)
    • October 2018 (139)
    • September 2018 (81)
    • August 2018 (124)
    • July 2018 (113)
    • June 2018 (90)
    • May 2018 (142)
    • April 2018 (151)
    • March 2018 (124)
    • February 2018 (157)
    • January 2018 (140)
    • December 2017 (118)
    • November 2017 (158)
    • October 2017 (186)
    • September 2017 (139)
    • August 2017 (212)
    • July 2017 (179)
    • June 2017 (214)
    • May 2017 (230)
    • April 2017 (223)
    • March 2017 (159)
    • February 2017 (175)
    • January 2017 (112)
    • December 2016 (8)
    • October 2016 (12)
    • June 2016 (15)
    • May 2016 (4)
    • April 2016 (10)
    • January 2016 (10)
    • December 2015 (2)
    • October 2015 (12)
    • September 2015 (2)
    • June 2015 (15)
    • April 2015 (15)
    • March 2015 (6)
    • February 2015 (7)
    • January 2015 (6)
    • December 2014 (18)
    • November 2014 (19)
    • October 2014 (24)
    • September 2014 (11)
    • August 2014 (13)
    • July 2014 (7)
    • June 2014 (36)
    • May 2014 (19)
    • April 2014 (21)
    • March 2014 (90)
    • February 2014 (5)
    • January 2014 (26)
    • December 2013 (10)
    • November 2013 (25)
    • October 2013 (37)
    • September 2013 (27)
    • August 2013 (8)
    • July 2013 (8)
    • June 2013 (31)
    • May 2013 (17)
    • April 2013 (103)
    • March 2013 (82)
    • February 2013 (120)
    • January 2013 (212)
    • December 2012 (128)
    • November 2012 (92)
    • October 2012 (159)
    • September 2012 (112)
    • August 2012 (153)
    • July 2012 (106)
    • June 2012 (91)
    • May 2012 (35)
    • April 2012 (49)
    • March 2012 (14)
    • February 2012 (19)
    • January 2012 (44)
    • December 2011 (9)
    • November 2011 (21)
    • October 2011 (45)
    • September 2011 (13)
    • August 2011 (9)
    • July 2011 (47)
    • May 2011 (46)
    • April 2011 (10)
    • March 2011 (25)
    • February 2011 (1)
    • January 2011 (17)
    • December 2010 (8)
    • October 2010 (19)
    • September 2010 (1)
    • July 2010 (23)
    • June 2010 (1)
    • May 2010 (1)
    • April 2010 (21)
    • March 2010 (1)
    • February 2010 (1)
    • January 2010 (4)
    • December 2009 (20)
    • November 2009 (4)
    • October 2009 (17)
    • September 2009 (11)
    • August 2009 (2)
    • July 2009 (2)
    • June 2009 (79)
    • April 2009 (20)
    • March 2009 (1)
    • January 2009 (22)
    • November 2008 (1)
    • October 2008 (1)
    • July 2008 (4)
    • June 2008 (22)
    • April 2008 (25)
    • February 2008 (1)
    • January 2008 (16)
    • December 2007 (17)
    • November 2007 (662)
    • October 2007 (410)
    • September 2007 (1)
    • November 1999 (1)

    ARTICLES & NEWS

    • Business Continuity
    • Disaster Recovery
    • Crisis Management & Communications
    • Risk Management
    • Article Archives
    • Industry News

    THE JOURNAL

    • Digital Edition
    • Young Professionals
    • Career Spotlight
    • Advertising & Media Kit
    • Submit an Article

    RESOURCES

    • White Papers
    • Rules & Regulations
    • FAQs
    • Glossary of Terms
    • Industry Groups
    • Business & Resource Directory
    • Business Resilience Decoded

    EVENTS

    • Fall 2021

    WEBINARS

    • Watch Now
    • Upcoming

    CONTACT

    • Article Submission
    • Media Kit
    • Contact Us

    ABOUT DRJ

    Disaster Recovery Journal is the industry’s largest resource for business continuity, disaster recovery, crisis management, and risk management, reaching a global network of more than 138,000 professionals. Offering weekly webinars, the latest industry news, rules and regulations, podcasts, the industry’s only official mentoring program, a quarterly magazine, and two annual live conferences, DRJ is leading the way to keep professionals up-to-date and connected in an ever-changing world.

    LEARN MORE

    TWITTER

    Disaster Recovery Journal is the leading publication/event covering business continuity/disaster recovery.

    Follow us for daily updates @drjournal

    Newsletter

    The Journal, right in your inbox.

    Be informed and stay connected by getting the latest in news, events, webinars and whitepapers on Business Continuity and Disaster Recovery.

    Subscribe Now
    Copyright 2021 Disater Recovery Journal
    • Terms of Use
    • Privacy Policy