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Novavax (NVAX) Initiates Phase III Study on COVID-19 Vaccine
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Novavax, Inc. (NVAX - Free Report) announced the initiation of phase III study, PREVENT-19, on its experimental coronavirus vaccine, NVX-CoV2373, in the United States and Mexico. The study will evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 in up to 30,000 people aged 18 years and older compared with placebo.
NVX-CoV2373 was generally well-tolerated, and demonstrated robust antibody responses and generated highly neutralizing antibodies against the virus in phase I/II studies. The research from the phase I/II studies led to the initiation of the phase III study.
Shares of the company have surged 2835.9% so far this year compared with the industry’s growth of 8.5%.
The study’s primary endpoint is to determine whether NVX-CoV2373 can prevent symptomatic COVID-19 disease, seven or more days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19.
The U.S. National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) are funding the study.
Meanwhile, a phase III study on NVX-CoV2373 in the United Kingdom and aphase IIb efficacy study in South Africa have completed full enrollment, with more than 20,000 participants dosed in these studies. Data from these studies are expected in the first quarter of 2021.
Several other companies are also evaluating candidates for the treatment of COVID-19. This month, Pfizer Inc. (PFE - Free Report) and BioNTech’s (BNTX - Free Report) mRNA-based coronavirus vaccine candidate, BNT162b2, was granted emergency use authorization (EUA) by the FDA on Dec 11. Thevaccine is now approved for emergency/temporary use in more than 40 countries including the United Kingdom, Bahrain, Mexico, Singapore, Switzerland and Canada. Moderna’scoronavirus vaccine, mRNA-1273, has been approved for emergency use in the United States and Canada.
J&J’s (JNJ - Free Report) single-dose COVID-19 vaccine candidate, JNJ-78436735, is being evaluated in the ENSEMBLE phase III study, which is now fully enrolled with approximately 45,000 participants. J&J expects to report interim efficacy data from the ENSEMBLE study by the end of January 2021. If the data are positive, J&J will file an application for EUA with the FDA in February.
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.4% per year. These 7 were selected because of their superior potential for immediate breakout.
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Novavax (NVAX) Initiates Phase III Study on COVID-19 Vaccine
Novavax, Inc. (NVAX - Free Report) announced the initiation of phase III study, PREVENT-19, on its experimental coronavirus vaccine, NVX-CoV2373, in the United States and Mexico. The study will evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 in up to 30,000 people aged 18 years and older compared with placebo.
NVX-CoV2373 was generally well-tolerated, and demonstrated robust antibody responses and generated highly neutralizing antibodies against the virus in phase I/II studies. The research from the phase I/II studies led to the initiation of the phase III study.
Shares of the company have surged 2835.9% so far this year compared with the industry’s growth of 8.5%.
The study’s primary endpoint is to determine whether NVX-CoV2373 can prevent symptomatic COVID-19 disease, seven or more days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19.
The U.S. National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) are funding the study.
Meanwhile, a phase III study on NVX-CoV2373 in the United Kingdom and aphase IIb efficacy study in South Africa have completed full enrollment, with more than 20,000 participants dosed in these studies. Data from these studies are expected in the first quarter of 2021.
Several other companies are also evaluating candidates for the treatment of COVID-19. This month, Pfizer Inc. (PFE - Free Report) and BioNTech’s (BNTX - Free Report) mRNA-based coronavirus vaccine candidate, BNT162b2, was granted emergency use authorization (EUA) by the FDA on Dec 11. Thevaccine is now approved for emergency/temporary use in more than 40 countries including the United Kingdom, Bahrain, Mexico, Singapore, Switzerland and Canada. Moderna’scoronavirus vaccine, mRNA-1273, has been approved for emergency use in the United States and Canada.
J&J’s (JNJ - Free Report) single-dose COVID-19 vaccine candidate, JNJ-78436735, is being evaluated in the ENSEMBLE phase III study, which is now fully enrolled with approximately 45,000 participants. J&J expects to report interim efficacy data from the ENSEMBLE study by the end of January 2021. If the data are positive, J&J will file an application for EUA with the FDA in February.
Novavax currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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