Warning: set_time_limit(): Cannot set max execution time limit due to system policy in /customers/b/b/b/brandspurng.com/httpd.www/wp-config.php on line 92 Moderna says preliminary trial data shows its COVID-19 Vaccine is 94.5% effective, shares soar - Brand Spur

Moderna says preliminary trial data shows its COVID-19 Vaccine is 94.5% effective, shares soar

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First interim analysis included 95 participants with confirmed cases of COVID-19

Phase 3 study met statistical criteria with a vaccine efficacy of 94.5% (p <0.0001)

Moderna intends to submit for an Emergency Use Authorization (EUA) with U.S. FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 months

Nov. 16, 2020Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.

more than 11% in premarket trading.
09/08/2016 CAMBRIDGE, MA Moderna offices in Cambridge. (Aram Boghosian for STAT)

Shares of the company jumped by more than 11% in premarket trading.

This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

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The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001).

A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases (as defined in the study protocol) in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.

The 95 COVID-19 cases included 15 older adults (ages 65+) and 20 participants identifying as being from diverse communities (including 12 Hispanic or LatinX, 4 Black or African Americans, 3 Asian Americans and 1 multiracial).

The interim analysis included a concurrent review of the available Phase 3 COVE study safety data by the DSMB, which did not report any significant safety concerns. A review of solicited adverse events indicated that the vaccine was generally well tolerated. The majority of adverse events were mild or moderate in severity.

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Grade 3 (severe) events greater than or equal to 2% in frequency after the first dose included injection site pain (2.7%), and after the second dose included fatigue (9.7%), myalgia (8.9%), arthralgia (5.2%), headache (4.5%), pain (4.1%) and erythema/redness at the injection site (2.0%). These solicited adverse events were generally short-lived. These data are subject to change based on ongoing analysis of further Phase 3 COVE study data and final analysis.

Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups.

As more cases accrue leading up to the final analysis, the Company expects the point estimate for vaccine efficacy may change. The Company plans to submit data from the full Phase 3 COVE study to a peer-reviewed publication.

Read Also:  WHO statement on AstraZeneca COVID-19 vaccine safety signals

“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, Chief Executive Officer of Moderna.

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“This milestone is only possible because of the hard work and sacrifices of so many. I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. They are an inspiration to us all.

I want to thank the NIH, particularly NIAID, for their scientific leadership including through years of foundational research on potential pandemic threats at the Vaccine Research Center that led to the discovery of the best way to make Spike protein antigens that are being used in our vaccine and others’.

I want to thank our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point. Finally, I want to thank the Moderna team, our suppliers and our partners, for their tireless work across research, development and manufacturing of the vaccine.

We look forward to the next milestones of submitting for a EUA in the U.S., and regulatory filings in countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE study. We remain committed to and focused on doing our part to help end the COVID-19 pandemic.”

Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least 2 months). Moderna also plans to submit applications for authorizations to global regulatory agencies.

Moderna is working with the U.S. Centers for Disease Control and Prevention (CDC), Operation Warp Speed and McKesson (NYSE: MCK), a COVID-19 vaccine distributor contracted by the U.S. government, as well as global stakeholders to be prepared for the distribution of mRNA-1273, in the event that it receives a EUA and similar global authorizations.

By the end of 2020, the Company expects to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. The Company remains on track to manufacture 500 million to 1 billion doses globally in 2021. On November 10, the American Medical Association (AMA) issued a Current Procedural Terminology (CPT) code to report vaccination with mRNA-1273 (code: 91301).

Moderna recently announced further progress towards ensuring the distribution, storage and handling of the vaccine can be done using existing infrastructure.

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Moderna says preliminary trial data shows its COVID-19 Vaccine is 94.5% effective, shares soar - Brand Spur

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Recognized for Completeness of Vision and Ability to Execute

 

HONG KONG SAR - Media OutReach - 13 May 2021 - Trend Micro Incorporated (TYO: 4704; TSE: 4704), a global cybersecurity leader, today announced that it has been positioned by Gartner as a Leader in the Magic Quadrant for Endpoint Protection Platform for its offering, Trend Micro Apex One. The evaluation was based on specific criteria that analyzed the company's overall completeness of vision and ability to execute.

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Read the full Magic Quadrant for Endpoint Protection Platform report at: https://resources.trendmicro.com/Gartner-Magic-Quadrant-Endpoints.html

"The endpoint has become a key battleground as determined threat actors try to take advantage of the pandemic to target distributed workforces and vulnerable remote access infrastructure. But throughout this difficult period, we've been there for our customers," said Wendy Moore, vice president of product marketing for Trend Micro. "I'm delighted to see us recognized again for doing what we do best: Protecting global organizations through innovative, cloud-first and platform-based security. We will continue to focus on offering simple, robust and industry-leading protection through our cybersecurity platform."

At the heart of the company's cybersecurity platform is Trend Micro Vision One, which delivers visibility and XDR using telemetry from Apex One in addition to email, servers, cloud workloads and networks for faster detections and investigations.

Magic Quadrant reports are a culmination of rigorous, fact-based research in specific markets, providing a wide-angle view of the relative positions of the providers in markets where growth is high and provider differentiation is distinct. Providers are positioned into four quadrants: Leaders, Challengers, Visionaries and Niche Players. The research enables you to get the most from market analysis in alignment with your unique business and technology needs.

* Gartner disclaimer: Gartner does not endorse any vendor, product or service depicted in our research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.


About Trend Micro

Trend Micro, a global cybersecurity leader, helps make the world safe for exchanging digital information. Fueled by decades of security expertise, global threat research, and continuous innovation, Trend Micro's cybersecurity platform protects hundreds of thousands of organizations and millions of individuals across clouds, networks, devices, and endpoints. As a leader in cloud and enterprise cybersecurity, the platform delivers a powerful range of advanced threat defense techniques optimized for environments like AWS, Microsoft, and Google, and central visibility for better, faster detection and response. With 7,000 employees across 65 countries, Trend Micro enables organizations to simplify and secure their connected world. www.trendmicro.com.hk


#TrendMicro


Moderna says preliminary trial data shows its COVID-19 Vaccine is 94.5% effective, shares soar - Brand Spur
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spot_imgspot_img

Latest News

Trend Micro Placed in 2021 Magic Quadrant for Endpoint Protection Platforms

Recognized for Completeness of Vision and Ability to Execute

 

HONG KONG SAR - Media OutReach - 13 May 2021 - Trend Micro Incorporated (TYO: 4704; TSE: 4704), a global cybersecurity leader, today announced that it has been positioned by Gartner as a Leader in the Magic Quadrant for Endpoint Protection Platform for its offering, Trend Micro Apex One. The evaluation was based on specific criteria that analyzed the company's overall completeness of vision and ability to execute.


Trend Micro is continually innovating and anticipating emerging threats. Our flagship Apex One endpoint protection platform features broad coverage against today's most critical threats. Our customers are protected using a range of techniques including virtual patching, which immediately protects against exploits until the vendor patch is applied.


Read the full Magic Quadrant for Endpoint Protection Platform report at: https://resources.trendmicro.com/Gartner-Magic-Quadrant-Endpoints.html

"The endpoint has become a key battleground as determined threat actors try to take advantage of the pandemic to target distributed workforces and vulnerable remote access infrastructure. But throughout this difficult period, we've been there for our customers," said Wendy Moore, vice president of product marketing for Trend Micro. "I'm delighted to see us recognized again for doing what we do best: Protecting global organizations through innovative, cloud-first and platform-based security. We will continue to focus on offering simple, robust and industry-leading protection through our cybersecurity platform."

At the heart of the company's cybersecurity platform is Trend Micro Vision One, which delivers visibility and XDR using telemetry from Apex One in addition to email, servers, cloud workloads and networks for faster detections and investigations.

Magic Quadrant reports are a culmination of rigorous, fact-based research in specific markets, providing a wide-angle view of the relative positions of the providers in markets where growth is high and provider differentiation is distinct. Providers are positioned into four quadrants: Leaders, Challengers, Visionaries and Niche Players. The research enables you to get the most from market analysis in alignment with your unique business and technology needs.

* Gartner disclaimer: Gartner does not endorse any vendor, product or service depicted in our research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.


About Trend Micro

Trend Micro, a global cybersecurity leader, helps make the world safe for exchanging digital information. Fueled by decades of security expertise, global threat research, and continuous innovation, Trend Micro's cybersecurity platform protects hundreds of thousands of organizations and millions of individuals across clouds, networks, devices, and endpoints. As a leader in cloud and enterprise cybersecurity, the platform delivers a powerful range of advanced threat defense techniques optimized for environments like AWS, Microsoft, and Google, and central visibility for better, faster detection and response. With 7,000 employees across 65 countries, Trend Micro enables organizations to simplify and secure their connected world. www.trendmicro.com.hk


#TrendMicro


Moderna says preliminary trial data shows its COVID-19 Vaccine is 94.5% effective, shares soar - Brand Spur
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