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Novavax coronavirus vaccine becomes fifth to begin Phase 3 trials in United States

Novavax on Monday...

Posted: Dec 28, 2020 8:29 AM
Updated: Dec 29, 2020 12:15 AM

Novavax on Monday announced the start of the Phase 3 trial of its Covid-19 vaccine in the United States and Mexico. It is the fifth company to launch a large-scale trial of a coronavirus vaccine in the United States.

The trial for the vaccine candidate, known as NVX-CoV2373, will evaluate safety, efficacy and immune response in up to 30,000 people age 18 and older. It builds on Phase 1/2 studies that demonstrated that the vaccine provoked an immune response and appeared to be safe.

The trial is examining whether the vaccine prevents Covid-19 symptoms, as well as moderate or severe Covid-19 symptoms. All participants will be followed for 24 months following their second injection.

Two-thirds of participants will be assigned to randomly receive two injections of vaccine administered 21 days apart, the remaining one-third will receive a placebo. The trials sites are in locations that currently have high transmission rates 'to accelerate the accumulation of positive cases that could show efficacy,' the release says.

Novavax says it aims for at least 25% of the study population to be age 65 or older, at least 15% to be Black, at least 10 to 20% Latinx and 1-2% American Indian.

'With the COVID-19 pandemic raging around the globe, this trial is a critical step in building the global portfolio of safe and effective vaccines to protect the world's population,' Stanley C. Erck, president and chief executive officer of Novavax, said in a news release.

The trial is being funded with up to $1.6 billion from Operation Warp Speed.

Novavax is also currently conducting a Phase 3 clinical study in the United Kingdom, a Phase 2b trial in South Africa and a Phase 1/2 continuation in the US and Australia, data from which are expected as soon as early first quarter 2021.

Two vaccines, from Pfizer/BioNTech and Moderna, have received emergency use authorization from the US Food and Drug Administration. Both began Phase 3 trials in the US in July and enrolled over 30,000 participants. Both are two dose vaccines and have been shown to have 95% and 94.1% efficacy respectively.

AstraZeneca began the Phase 3 US trial of its coronavirus vaccine in September. Johnson & Johnson, which is testing a single-dose vaccines, expects efficacy results from its Phase 3 trial by January or February.

California Coronavirus Cases

Data is updated nightly.

Cases: 3095814

Reported Deaths: 35549
CountyCasesDeaths
Los Angeles104602114641
San Bernardino2587421561
Riverside2558082739
San Diego2197312222
Orange2178492546
Santa Clara959361158
Kern87240572
Fresno83591968
Sacramento816871128
Alameda69107842
Ventura63413462
San Joaquin58843788
Contra Costa53349460
Stanislaus43392773
Tulare42186515
Monterey36464255
San Mateo33207309
San Francisco29665274
Solano26191108
Santa Barbara25405243
Imperial25380486
Merced24570316
Sonoma24262242
Kings19588148
Placer17584186
San Luis Obispo16056140
Madera13585151
Santa Cruz12461113
Marin11732159
Yolo10852138
Shasta9750123
Butte9582128
El Dorado788649
Sutter782879
Napa773145
Lassen519916
San Benito504246
Yuba499627
Tehama433244
Tuolumne340340
Nevada323874
Mendocino319232
Amador303631
Lake264631
Humboldt245825
Glenn195520
Colusa17969
Calaveras163723
Siskiyou145713
Mono11244
Inyo98329
Del Norte8672
Plumas5895
Modoc3853
Mariposa3464
Trinity3044
Sierra820
Alpine730
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