Pfizer’s Novel COVID-19 Oral Antiviral Treatment Candidate Reduced Risk of Hospitalization or Death by 89% in Interim Analysis of Phase 2/3 EPIC-HR Study

• PAXLOVID™ (PF-07321332; ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19
• In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 deaths in patients who received placebo
• Pfizer plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA) as soon as possible

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced its investigational novel COVID-19 oral antiviral candidate,PAXLOVID™, significantly reduced hospitalization and death, based on an interim analysis of the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) randomized, double-blind study of non-hospitalized adult patients with COVID-19, who are at high risk of progressing to severe illness. The scheduled interim analysis showed an 89% reduction in risk of COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset (primary endpoint); 0.8% of patients who received PAXLOVID™ were hospitalized through Day 28 following randomization (3/389 hospitalized with no deaths), compared to 7.0% of patients who received placebo and were hospitalized or died (27/385 hospitalized with 7 subsequent deaths). The statistical significance of these results was high (p<0.0001). Similar reductions in COVID-19-related hospitalization or death were observed in patients treated within five days of symptom onset; 1.0% of patients who received PAXLOVID™ were hospitalized through Day 28 following randomization (6/607 hospitalized, with no deaths), compared to 6.7% of patients who received a placebo (41/612 hospitalized with 10 subsequent deaths), with high statistical significance (p<0.0001). In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 (1.6%) deaths in patients who received placebo.

At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), Pfizer will cease further enrollment into the study due to the overwhelming efficacy demonstrated in these results and plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA) as soon as possible.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic. These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Given the continued global impact of COVID-19, we have remained laser-focused on the science and fulfilling our responsibility to help healthcare systems and institutions around the world while ensuring equitable and broad access to people everywhere.”

Paul Anastas, a Yale professor and pioneer in developing non-hazardous chemicals, wins the 2021 Volvo Environment Prize, one of the world's most respected scientific environmental awards. The research of Paul Anastas "is revolutionizing the chemical industry, a key contribution to meeting the sustainability challenge," says the Prize Jury.

Everything we touch, see and feel is chemical, whether it's furniture, clothes we wear, medicines we take, or electronics that we use. For the past two centuries, chemistry has been creating technological miracles, increasing the human quality of life. But its performance has also led to unintended consequences of pollution, waste, and toxicity.

The National Academies of Sciences, Engineering, and Medicine are pleased to share with you information about the first meeting of the newly convened Strategic Council for Research Excellence, Integrity, and Trust. You are cordially invited to attend the Council’s first meeting virtually on Monday, October 25, 2021 from 12:00-1:00 PM U.S. Eastern Time.
 
Co-chaired by Dr. Marcia McNutt (President, National Academy of Sciences), Dr. David Allison (Dean, Distinguished Professor, and Provost Professor, Indiana University School of Public Health – Bloomington), and Dr. France Cordova (President, Science Philanthropy Alliance and former Director, National Science Foundation), the Strategic Council will serve as a venue for multiple stakeholders to advance collectively the integrity, ethics, resilience, and effectiveness of the research enterprise while at the same time preparing it for tomorrow’s challenges.

The Strategic Council is charged with:

• Identifying, anticipating and prioritizing key challenges to research ethics, integrity and trustworthiness,
• Articulating principles, policies and best practices to address them,
• Catalyzing progress by coordinating collaborative actions, and
• Breaking barriers where needed to accelerate solutions, be they conceptual, technological, cultural, or procedural.

The project is supported by the Gordon and Betty Moore Foundation and the National Academy of Sciences – Ralph J. and Carol M. Cicerone Endowment for NAS Missions.

Since its inception, the Day One Talent Hub has been working to create pathways for scientists, technologists, and talented policy entrepreneurs to enter the federal government to work on the Administration’s most pressing policy priorities. Today, we’re thrilled to announce two new Impact Fellowships for S&T experts seeking to advance smart policy: the Energy Innovation Fellowship at the Department of Energy and the Education Data Science Fellowship at the Department of Education.

Impact Fellows in these two cohorts will join the Day One Project for a three-month-long fellowship before a year-long assignment at their respective federal agencies. The fellowship will prepare Impact Fellows for success in the federal government, offering tools to become better policymakers and providing opportunities to expand professional networks.

Applications for both Impact Fellowship Cohorts are now open and will close on September 28th at 11:59 PM ET. If you or anyone in your network is interested in joining an Impact Fellowship Cohort, please visit our website for more information or contact [email protected] with any questions.

James Carroll, CEO of THOR Photomedicine, a speaker at the 2019 CSSP Spring Leadership Workshop, received the T.H. Maimen Award for outstanding research during the Academy for Laser Dentistry’s (ALD) award ceremony at their annual conference (April 8-10), during which Red Light Therapy’s role in revolutionizing medical care was showcased.  Kathleen Maimen, widow of Laser inventor Theodore Maimen, presented the award.

Carroll, a Fellow of the Royal Society of Medicine, is considered the world’s leading proponent of using Red Light Therapy, also known as Photobiomodulation (PBM).  He has written or co-authored twenty-four academic papers and co-authored four books on the subject. 

Carroll is working with 36 medical institutions, including Harvard Medical School, St. Jude Children’s Hospital, Veterans’ Hospitals, and the UK National Health Service (NHS), on using PBM for treating a range of conditions such as traumatic brain injury, the side effects of cancer treatments, managing acute and chronic pain, and reducing opioid use.

The Council of Scientific Society Presidents has been made aware of an opportunity from the Directorate for Biological Sciences (BIO) of the National Science Foundation (NSF) that we are pleased to be able to share. Scientific societies are in a unique position to be able to lead change that will expand and enhance the structure and culture of science networks.

CSSP is pleased to share this important opportunity with our community.

The Science and Technology Action Committee is seeking endorsements from organizations for the Science & Technology Action Plan that has been developed. The plan includes recommendations for ways to invest in ourselves, and our country to drive the innovation and change that can serve our nation and our planet.

The U.S. science and technology (S&T) enterprise is highly innovative and productive and federally centralized efforts will allow for better and quicker response to challenges at the scope and scale to increase research, development and education.

Dr. Deborah Bronk, President of Bigelow Laboratory for Ocean Sciences and former CSSP Chair, has been named as an American Association for the Advancement of Science Fellow.

She was recognized for substantial research advances on the marine nitrogen cycle and for leadership in the ocean science research community.

More information on the 2020 AAAS Fellows

This webinar, co-organised by STM, CHORUS and the Center for Open Science, is part of a series organized in the context of STM’s Research Data Year presenting speakers from a variety of stakeholder groups sharing the same goal: making research data more Open and FAIR. For recordings of earlier webinars, click here.

In this webinar, Dr. Robert J. Hanisch will present NIST's initiative to create a Research Data Framework in the US with the aim of improving research integrity, cost and efficiency, risk management, and amplifying scientific discovery and innovation. The initiative is based on the demonstrated success of the “Framework for Improving Critical Infrastructure Cybersecurity” which NIST initially issued in February 2014.

Dr. Hanisch’s presentation will be followed by a panel discussion on the merits of this effort in the context of making research data more Open and FAIR, consisting of: