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Novavax Coronavirus Vaccine Begins Phase 3 Trials in the United States and Mexico | CNN

2020-12-29T18:55:59.995Z


Novavax announced on Monday 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. | Health | CNN


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(CNN) -

Novavax announced on Monday 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 candidate vaccine, known as NVX-CoV2373, will evaluate safety, efficacy and immune response in up to 30,000 people 18 years of age and older.

It is based on phase 1/2 studies that showed the vaccine elicited an immune response and appeared safe.

The trial is examining whether the vaccine prevents symptoms of Covid-19, both moderate and severe.

All participants will be followed for 24 months after the second injection.

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Two-thirds of the participants will be randomly assigned to receive two vaccine injections given 21 days apart, the remaining third will receive a placebo.

The test sites are in locations that currently have high transmission rates "to accelerate the backlog of positive cases that could show efficacy," the statement said.

Novavax says its goal is for at least 25% of the study population to be 65 or older, at least 15% to be black, at least 10 to 20% Latino, and 1 to 2% indigenous. Americans.

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"With the COVID-19 pandemic worldwide, this trial is a critical step in building the global portfolio of safe and effective vaccines to protect the world's population," said Stanley C. Erck, President and CEO of Novavax, in a press release.

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The test 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 UK, a phase 2b trial in South Africa, and a follow-up phase 1/2 in the US and Australia, with data expected early in the first quarter. of 2021.

Two vaccines, from Pfizer / BioNTech and Moderna, received emergency use authorization from the US Food and Drug Administration. Both began Phase 3 trials in the US in July and enrolled more than 30,000 participants. .

Both are two-dose vaccines and have been shown to be 95% and 94.1% effective, respectively.

AstraZeneca began the US phase 3 trial of its coronavirus vaccine in September.

Johnson & Johnson, which is testing single-dose vaccines, expects efficacy results from its phase 3 trial in January or February.

Source: cnnespanol

All news articles on 2020-12-29

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