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Novavax's (NVAX) COVID-19 Vaccine 89.3% Effective in U.K. Study
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Novavax, Inc. (NVAX - Free Report) announced that a phase III study evaluating its coronavirus vaccine candidate NVX-CoV2373 in the United Kingdom met the primary endpoint, demonstrating a vaccine efficacy of 89.3%. Meanwhile, the study also demonstrated efficacy of the vaccine against both the rapidly emerging U.K. and South African variants of the virus.
Shares of Novavax were up 26.5% in after-hours-trading on Thursday following announcement of the news. In fact, the stock has skyrocketed 1859.2% in the past year compared with the industry’s increase of 12.9%.
The study, which was conducted in partnership with the U.K. government’s Vaccines Taskforce, assessed efficacy of the vaccine during a time with high transmission and with a new U.K. variant strain of the virus having been identified.
Per the company, the study in the United Kingdom enrolled more than 15,000 participants aged between 18 to 84 years where 27% of the participants were 65 years old and above.
Also, preliminary analysis showed that the U.K. variant strain was detected in more than 50% of the PCR-confirmed symptomatic cases. Based on PCR performed on strains from 56 of the 62 cases, the efficacy by strain was found to be 95.6% against the original COVID-19 strain and 85.6% against the highly transmissible U.K. variant strain.
Please note that Novavax has already initiated a rolling submission for NVX-CoV2373 in the United Kingdom.
Meanwhile, the company also announced positive results from the phase IIb study on NVX-CoV2373 in South Africa. The study demonstrated 60% efficacy for the prevention of mild, moderate and severe COVID-19 disease in 94% of the study population that was HIV-negative.
Importantly, more than 90% of sequenced cases were attributable to the prevalent South African escape variant. The Coalition for Epidemic Preparedness Innovations has funded this phase IIb study in South Africa, which also received a grant of $15 million from the Bill & Melinda Gates Foundation.
Notably, NVX-CoV2373 is the first coronavirus vaccine candidate, which has demonstrated clinical efficacy against the original COVID-19 infection as well as both the U.K. and South Africa variants of the virus. If successfully developed, this can be a major breakthrough for Novavax and might help the company gain an edge over its competitors.
Additionally, Novavax is conducting the phase III PREVENT-19 study which is evaluating the efficacy, safety and immunogenicity of NVX-CoV2373 in the United States and Mexico. The study has already randomized more than 16,000 participants and is looking to enroll 30,000 participants.
We note that several companies have already launched vaccines for fighting the COVID-19 virus.
Pfizer (PFE - Free Report) / BioNTech’s mRNA-based COVID-19 vaccine, BNT162b2, is approved for emergency/temporary/conditional use in several countries, including the United States and 27 EU member countries. Another mRNA-based COVID-19 vaccine candidate, mRNA-1273, developed by Moderna, Inc. (MRNA - Free Report) has been approved for emergency/temporary use in the United States, Europe and a few other countries.
AstraZeneca’s (AZN - Free Report) adenovirus-based coronavirus vaccine candidate, AZD1222, developed in partnership with the University of Oxford, is also approved for emergency use in the United Kingdom, India and a few other countries.
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
Image: Shutterstock
Novavax's (NVAX) COVID-19 Vaccine 89.3% Effective in U.K. Study
Novavax, Inc. (NVAX - Free Report) announced that a phase III study evaluating its coronavirus vaccine candidate NVX-CoV2373 in the United Kingdom met the primary endpoint, demonstrating a vaccine efficacy of 89.3%. Meanwhile, the study also demonstrated efficacy of the vaccine against both the rapidly emerging U.K. and South African variants of the virus.
Shares of Novavax were up 26.5% in after-hours-trading on Thursday following announcement of the news. In fact, the stock has skyrocketed 1859.2% in the past year compared with the industry’s increase of 12.9%.
The study, which was conducted in partnership with the U.K. government’s Vaccines Taskforce, assessed efficacy of the vaccine during a time with high transmission and with a new U.K. variant strain of the virus having been identified.
Per the company, the study in the United Kingdom enrolled more than 15,000 participants aged between 18 to 84 years where 27% of the participants were 65 years old and above.
Also, preliminary analysis showed that the U.K. variant strain was detected in more than 50% of the PCR-confirmed symptomatic cases. Based on PCR performed on strains from 56 of the 62 cases, the efficacy by strain was found to be 95.6% against the original COVID-19 strain and 85.6% against the highly transmissible U.K. variant strain.
Please note that Novavax has already initiated a rolling submission for NVX-CoV2373 in the United Kingdom.
Meanwhile, the company also announced positive results from the phase IIb study on NVX-CoV2373 in South Africa. The study demonstrated 60% efficacy for the prevention of mild, moderate and severe COVID-19 disease in 94% of the study population that was HIV-negative.
Importantly, more than 90% of sequenced cases were attributable to the prevalent South African escape variant. The Coalition for Epidemic Preparedness Innovations has funded this phase IIb study in South Africa, which also received a grant of $15 million from the Bill & Melinda Gates Foundation.
Notably, NVX-CoV2373 is the first coronavirus vaccine candidate, which has demonstrated clinical efficacy against the original COVID-19 infection as well as both the U.K. and South Africa variants of the virus. If successfully developed, this can be a major breakthrough for Novavax and might help the company gain an edge over its competitors.
Additionally, Novavax is conducting the phase III PREVENT-19 study which is evaluating the efficacy, safety and immunogenicity of NVX-CoV2373 in the United States and Mexico. The study has already randomized more than 16,000 participants and is looking to enroll 30,000 participants.
We note that several companies have already launched vaccines for fighting the COVID-19 virus.
Pfizer (PFE - Free Report) / BioNTech’s mRNA-based COVID-19 vaccine, BNT162b2, is approved for emergency/temporary/conditional use in several countries, including the United States and 27 EU member countries. Another mRNA-based COVID-19 vaccine candidate, mRNA-1273, developed by Moderna, Inc. (MRNA - Free Report) has been approved for emergency/temporary use in the United States, Europe and a few other countries.
AstraZeneca’s (AZN - Free Report) adenovirus-based coronavirus vaccine candidate, AZD1222, developed in partnership with the University of Oxford, is also approved for emergency use in the United Kingdom, India and a few other countries.
Zacks Rank
Novavax currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>