First Phase 3 clinical trial of a coronavirus vaccine in the United States begins

The first Phase 3 clinical trial of a coronavirus vaccine in the United States began Monday.

Posted: Jul 27, 2020 8:46 AM
Updated: Jul 27, 2020 8:59 AM

(CNN) -- The first Phase 3 clinical trial of a coronavirus vaccine in the United States began Monday.

The investigational vaccine was developed by the biotechnology company Moderna and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The 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 and evaluates 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.

Results from a Phase 1 trial of the vaccine published earlier this month 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, pain at the injection site.

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, according to the US Centers for Disease Control and Prevention. 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 Organization.

Moderna is one of several companies that received support from Operation Warp Speed, the federal government's Covid-19 vaccine program. On Sunday, Moderna announced it had received an additional $472 million from the Biomedical Advanced Research and Development Authority for Phase 3 study and development of its Covid-19 vaccine, bringing the total to $955 million.

According to Johns Hopkins University's tally of cases in the United States, there are more than 4.2 million confirmed cases of coronavirus in the United States and at least 146,935 people have died.

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California Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 526685

Reported Deaths: 9684
CountyConfirmedDeaths
Los Angeles1958054760
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Orange38066653
San Bernardino34017477
San Diego30516568
Kern21228151
Fresno15759138
San Joaquin11958180
Alameda11909192
Santa Clara11030192
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Tulare9990193
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Contra Costa8176131
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San Francisco698961
Santa Barbara652663
San Mateo5744120
Marin518076
Monterey496634
Merced458351
Kings445356
Solano380638
Sonoma311339
Madera211432
Placer195318
San Luis Obispo192616
Yolo161442
Santa Cruz11964
Butte10128
Napa9809
Sutter8406
San Benito6894
El Dorado6681
Lassen6320
Yuba5334
Shasta3979
Colusa3574
Mendocino3419
Glenn3321
Nevada3161
Tehama2461
Humboldt2454
Lake2111
Mono1451
Tuolumne1442
Amador1370
Calaveras1361
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