We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us

Download Mobile App





Moderna Set to Initiate Phase 3 Trial of COVID-19 Vaccine in July

By HospiMedica International staff writers
Posted on 04 Jun 2020
Print article
Illustration
Illustration
Moderna, Inc. (Cambridge, MA, USA) will begin Phase 3 trial of its experimental COVID-19 vaccine in July that will involve 30,000 patients aged as young as 18 years as well as elderly Americans.

This information was shared by Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, in an interview with the editor of JAMA. Fauci stated that the “randomized placebo” controlled trial of Moderna’s vaccine against the novel coronavirus (SARS-CoV-2) would include mainly US sites, although it would also include international sites.

Last week, Moderna had begun dosing the first participants in each age cohort in the company’s Phase 2 study of its mRNA vaccine candidate (mRNA-1273) against the novel coronavirus. The Phase 2 study, being conducted by Moderna under its own Investigational New Drug (IND) application, will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. However, Dr. Fauci confirmed that the work is well underway for initiating a much larger Phase 3 trial that will begin in early July. A Phase 3 trial is considered to be the final stage ahead of potential approval by the US Food and Drug Administration and would make the COVID-19 vaccine available across the country.

“We are preparing the sites for the Phase 3 study,” Dr. Fauci, America's top infectious disease expert, told Dr. Howard Bauchner, editor of JAMA during the interview. “The real business end of this all is the Phase 3 trial that starts in the first week in July.”

Meanwhile, speaking at a Wall Street Journal Tech Health Conference, Dr. Fauci said that he was 'cautiously optimistic' that the US would have an effective coronavirus vaccine 'within a reasonable period of time' but expressed concern over the lack of clarity on how long the vaccine protection would last. “What is a big unknown is what the durability of that protection is,' Dr. Fauci said during the conference. “Is it going to be a year, two years or even maybe, unfortunately, six months or less? Then we have a secondary problem. We may have overcome the first problem of getting a vaccine, but then you're in a logistical situation.”

Related Links:
Moderna, Inc.

Gold Member
Solid State Kv/Dose Multi-Sensor
AGMS-DM+
Gold Member
Disposable Protective Suit For Medical Use
Disposable Protective Suit For Medical Use
Silver Member
Wireless Mobile ECG Recorder
NR-1207-3/NR-1207-E
New
High Power Laser System
Dornier Thulio

Print article

Channels

Critical Care

view channel
Image: Researchers have developed a novel risk score for cardiovascular complications after bone marrow transplant (Photo courtesy of 123RF)

Novel Tool Predicts Cardiovascular Risks after Bone Marrow Transplantation

Every year, thousands of people undergo bone marrow transplants to potentially cure serious diseases like leukemia, lymphoma, and immune deficiency disorders. While these transplants can be lifesaving,... Read more

Surgical Techniques

view channel
Image: The Early Bird Bleed Monitoring System provides visual and audible indicators of the onset and progression of bleeding events (Photo courtesy of Saranas)

Novel Technology Monitors and Lowers Bleeding Complications in Patients Undergoing Heart Procedures

Bleeding complications at the femoral access site can significantly hamper recovery, affecting the success of procedures, patient satisfaction, and overall healthcare costs. It is crucial for surgeons... Read more

Patient Care

view channel
Image: The newly-launched solution can transform operating room scheduling and boost utilization rates (Photo courtesy of Fujitsu)

Surgical Capacity Optimization Solution Helps Hospitals Boost OR Utilization

An innovative solution has the capability to transform surgical capacity utilization by targeting the root cause of surgical block time inefficiencies. Fujitsu Limited’s (Tokyo, Japan) Surgical Capacity... Read more

Health IT

view channel
Image: First ever institution-specific model provides significant performance advantage over current population-derived models (Photo courtesy of Mount Sinai)

Machine Learning Model Improves Mortality Risk Prediction for Cardiac Surgery Patients

Machine learning algorithms have been deployed to create predictive models in various medical fields, with some demonstrating improved outcomes compared to their standard-of-care counterparts.... Read more

Point of Care

view channel
Image: The new eye-safe laser technology can diagnose traumatic brain injury (Photo courtesy of 123RF)

Novel Diagnostic Hand-Held Device Detects Known Biomarkers for Traumatic Brain Injury

The growing need for prompt and efficient diagnosis of traumatic brain injury (TBI), a major cause of mortality globally, has spurred the development of innovative diagnostic technologies.... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.