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Novavax coronavirus vaccine becomes fifth to begin Phase 3 trials in United States
Source: CNN
Novavax coronavirus vaccine becomes fifth to begin Phase 3 trials in United States
By Naomi Thomas, CNN
Updated 1427 GMT (2227 HKT) December 28, 2020
(CNN) — 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% [Native] American
-snip-
By Naomi Thomas, CNN
Updated 1427 GMT (2227 HKT) December 28, 2020
(CNN) — 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% [Native] American
-snip-
Read more: https://edition.cnn.com/2020/12/28/health/novavax-covid-vaccine-trial-phase-3/index.html