CNN reported on Monday that the first Phase 3 clinical trial of a COVID-19 vaccine in the US began on 27 July 2020.
The investigational vaccine was developed by biotechnology company Moderna and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
This trial is to be conducted at nearly 100 US research sites, according to Moderna. The first patient was dosed at a site in Savannah, Georgia.
The trial is expected to enroll about 30,000 adult volunteers. It will evaluate the safety of the Moderna/NIH vaccine and whether it can prevent symptomatic COVID-19 after two doses, among other outcomes.
Volunteers will receive either two 100 microgram injections of the vaccine or a placebo about 28 days apart. Investigators and participants will not know who has received the vaccine.
According to CNN, results from a phase 1 trial of the vaccine published earlier in July 2020 in the New England Journal of Medicine found it induced immune responses in all of the volunteers and was generally safe. It had mild side effects, including fatigue, chills, headache, muscle pain and pain at the injection site.
According to the US Centres for Disease Control and Prevention, a Phase 1 study typically studies a small number of people and focuses on whether a vaccine is safe and elicits an immune response. In Phase 2, the clinical study is expanded and the vaccine is given to people who have characteristics, such as age and physical health, similar to those for whom the new vaccine is intended,
In Phase 3, the vaccine is given to thousands of people and tested for efficacy and again for safety.
The Moderna/NIH vaccine is one of 25 in clinical trials around the world, according to the World Health Organisation.
INOVIO prices USD25m public offering
Blacksmith Medicines granted US patent for antibacterial compounds targeting LpxC
Seegene launches STAgora infectious disease analytics platform
hVIVO supports Cidara Therapeutics' positive Phase 2b influenza study results
Immuno Cure and PharmaJet collaborate for novel HIV therapeutic DNA vaccine advancement
Oxurion signs LOI to acquire majority stake in preclinical microbiology CRO
bioMérieux acquires Day Zero Diagnostics assets to expand rapid sequencing diagnostics
EDX Medical and Spire Healthcare sign strategic diagnostic partnership agreement
FDA grants priority review to Innoviva's zoliflodacin for treatment of gonorrhea
Ondine's Steriwave proven effective against deadly Mucor fungus
Mycovia Pharmaceuticals reports first participant enrolled in Phase 2 cryptococcal meningitis study
bioMérieux launches rapid PCR test for equine respiratory diseases
Ondine Biomedical joins CAN Health Network to advance Steriwave adoption in Canada
Seegene presrnts CURECA conceptual video at ESCMID Global 2025
GC Biopharma's BARYTHRAX receives Korean regulatory approval