We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » NIH to Begin Evaluating Moderna Vaccine Modified Against South African Strain

NIH to Begin Evaluating Moderna Vaccine Modified Against South African Strain

February 25, 2021

The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) will soon begin a phase 1 clinical trial of Moderna’s variant-specific COVID-19 vaccine candidate, mRNA-1273.351, which has been tailored to better protect against the virus’ South African mutation. Moderna will also conduct trials of its own.

The drugmaker announced Wednesday that it has shipped doses of its modified COVID-19 vaccine to the NIH for evaluation in a phase 1 trial of the candidate. The NIAID, which is both leading and funding the research, will assess if the rejiggered vaccine can serve as a viable booster shot against the fast-spreading strain. The trial will kick off once the FDA has given its go-ahead.

Moderna, which first announced its efforts on a modified vaccine a month ago, said it is also spearheading its own clinical studies to support regulatory filings for any booster shot or updates to its primary vaccine. It plans to evaluate the modified vaccine on its own, the modified vaccine combined with the company’s original vaccine and a third shot of its original vaccine as a booster. It will also evaluate the original and modified vaccine combination as a primary vaccination for patients who are seronegative — meaning they don’t have antibodies against the virus in their blood serum.

The two-dose Moderna vaccine looks to have diminished efficacy against the South African mutation but appears to still offer protection. The company said that “while initial data confirm that [our] vaccine provides neutralizing activity against variants of concern,” it is taking action against viral mutations “out of an abundance of caution.”

“We are moving quickly to test updates to the vaccines that address emerging variants of the virus in the clinic. Moderna is committed to making as many updates to our vaccine as necessary until the pandemic is under control,” said Moderna CEO Stéphane Bancel. “We hope to demonstrate that booster doses, if necessary, can be done at lower dose levels, which will allow us to provide many more doses to the global community in late 2021 and 2022 if necessary.”

The company intends to follow the FDA’s recently published guidance on amending Emergency Use Authorizations for modified vaccines by evaluating immunogenicity and safety in both nonvaccinated patients and patients who have received its vaccine. Peter Marks, director of the Center for Biologics Evaluation and Research, has said the agency expects modified vaccine trials to take around “two to three months” and consist of “a few hundred individuals” (DID, Feb. 23). — James Miessler

COVID-19

Upcoming Events

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

  • 06May

    The World of Post-COVID-19 Clinical Trials: How to Prepare for What’s Coming Next

  • 12May

    Extractables and Leachables: 101

  • 19May

    CDRH’s New Accreditation Scheme for Conformity Assessment: Impacts on Your Future Testing Plans and FDA Submissions

  • 25May

    How Can the Accelerated Availability of Pfizer-BioNTech’s COVID-19 Vaccine be Replicated?

  • 27May

    Evolving Clinical Trials: Continuing the Journey from Paper to Digital

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Fujifilm_Logo.gif

    Fujifilm Begins Late-Stage Trial of Avigan for COVID-19

  • CE mark

    DiaSorin’s 10-Minute COVID-19 Antibody Test CE Marked

  • WHO

    WHO Will Review Two COVID-19 Vaccines from China

  • CE mark

    Qiagen’s High Throughput COVID-19 Test Earns CE Mark

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing