New Yorkers have found their daily routines disrupted once more as a surge of cases due to the new Omicron variant could not be ignored during the holiday season. As the city broke its previous single-day COVID case record, residents have been lining up at testing sites, with queues that wrap around city blocks in many places. Some restaurants have closed, and performances on and off Broadway have been canceled as staff test positive. “We’re going to have a challenging few weeks, but the good news is based on everything our healthcare leadership understands at this moment, we are talking about a matter of weeks,” Mayor de Blasio said on Monday. “We’re going to see a really fast upsurge in cases.
In the meantime, pharmaceutical companies are working to understand just how effective their vaccines are against the Omicron variant. For instance, according to a report by USA Today, Moderna’s vaccine data does suggests a third booster dose will be effective against Omicron. In addition, a study that was released earlier this month by Pfizer and their partner BioNTech showed that a third dose of their vaccine boosted neutralizing antibodies against Omicron more than 25-fold, which should be protective, Topol said, though real-world studies are needed to prove it.
Todos Medical Ltd. just announced breaking news that it is hosting a Key Opinion Leader webinar with LifeSci Advisors today entitled Tollovir™: Potential Treatment for Covid-19. This webinar, which will take place on December 22, 2021 at 12:00pm ET, featuring presentations from Key Opinion Leaders (KOL’s) Yossef Av-Gay, PhD Professor of Infectious Diseases at the University of British Columbia on 3CL protease antiviral biology and David Greenberg, MD, Chairman of Pediatrics Faculty of Health Sciences of the Ben-Gurion University of the Negev)…
A presentation by Dr. Dorit Arad (NLC Pharma, JV partner with Todos Medical) will follow and review the key mechanistic principles that led to the development of Tollovir™ and some of the key data that led to its continued development as a botanical drug candidate. We will examine the competitive landscape given significant activity from Merck studies as well discuss what’s upcoming, including Todos Medical’s Tollovir™ 3CL protease inhibitor oral antiviral Phase II clinical trial results in hospitalized COVID-19 patients, expected to be released to the public in the near future.
David Greenberg, MD is an Associated Professor at the Faculty of Health Sciences of the Ben-Gurion University of the Negev. He is serving as the Chairman of the Israeli Clinical Pediatric Society. Dr. Greenberg is a member of the COVID vaccines advisory team for the Ministry of Health in Israel. Dr. Greenberg obtained his MD from Ben-Gurion University of the Negev in Beer-Sheva, Israel in 1991, was boarded in Pediatrics in 1996, and did his fellowship in Pediatric Infectious Diseases at “The Children’s Hospital” in Vancouver from 1997 to1999. He was boarded in Infectious Diseases in Israel in 2000. He joined the Department of Pediatrics and the Pediatric Infectious Disease Unit of Soroka University Medical Center as a pediatrician and a senior consultant in Pediatric Infectious Diseases in 1999. In collaboration with various researchers from several universities worldwide, Dr. Greenberg was a member World Health Organization Pneumonia Vaccine Trial Investigators’ Group and of the Pneumococcal Molecular Epidemiology Network (PMEN)…
Yossef Av-Gay, PhD is a University of British Columbia (UBC) professor in the Division of Infectious Diseases, Faculty of Medicine and is an associate member of the Department of Microbiology and Immunology, Faculty of Sciences. He is also an associate member of the department of microbiology and immunology and holds an adjunct professorship at the medical school of Ben Gurion University of the Negev, Israel. Prof. Av-Gay received his BSc in Biology, MSc in Microbiology, and PhD in Microbial Genetics – all from Tel Aviv University, Tel Aviv, Israel, and advanced training at John Innes Institute, Norwich, UK, Albert Einstein Collage of Medicine, New York and UBC Microbiology…
For more information, please visit www.todosmedical.com. For more information on the Company’s CLIA/CAP certified lab Provista Diagnostics, Inc. please visit www.provistadx.com.”
Merck & Co., Inc. announced last week the New England Journal of Medicine has published findings from the Phase 3 MOVe-OUT trial evaluating molnupiravir, an investigational oral antiviral medicine, in non-hospitalized high risk adults with mild to moderate COVID-19. Data from MOVe-OUT demonstrated that early treatment with molnupiravir significantly reduced the risk of hospitalization or death in high risk, unvaccinated adults with COVID-19. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. Molnupiravir is authorized in the United Kingdom as the first oral antiviral for the treatment of mild to moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. The European Medicines Agency (EMA) issued a positive scientific opinion for molnupiravir under Article 5.3 Regulation 726/2004, which is intended to support national decision-making on the possible use of molnupiravir prior to marketing authorization. Regulatory applications are under review or are in the process of being submitted, including applications for Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labor and Welfare.
Pfizer Inc. and BioNTech SE announced on December 20th, an agreement has been reached with the European Commission (EC) and its member states to exercise an option to purchase more than 200 million additional doses of COMIRNATY®, the companies’ COVID-19 vaccine. Contractual details are currently being finalized. These 200 million optional doses are in addition to the 450 million doses already planned to be delivered in 2022 based on previously signed agreements. The number of doses to be delivered to the EC member states by the companies in 2022 will now total more than 650 million doses. This order would also cover potential vaccines adapted to the Omicron variant without additional costs, if a variant vaccine is determined to be needed and subsequently authorized or approved.
Moderna, Inc. announced on December 20th, preliminary neutralizing antibody data against the Omicron variant following the Company’s booster candidates at 50 µg and 100 µg dose levels. The currently authorized 50 µg booster of mRNA-1273 increased neutralizing antibody levelsagainst Omicron approximately 37-fold compared to pre-boost levels and a 100 µg dose of mRNA-1273 increased neutralizing antibody levelsapproximately 83-fold compared to pre-boost levels. “The dramatic increase in COVID-19 cases from the Omicron variant is concerning to all. However, these data showing that the currently authorized Moderna COVID-19 booster can boost neutralizing antibody levels 37-fold higher than pre-boost levels are reassuring,” said Stéphane Bancel, Chief Executive Officer of Moderna. “To respond to this highly transmissible variant, Moderna will continue to rapidly advance an Omicron-specific booster candidate into clinical testing in case it becomes necessary in the future. We will also continue to generate and share data across our booster strategies with public health authorities to help them make evidence-based decisions on the best vaccination strategies against SARS-CoV-2.”
Novavax, Inc. announced on December 20th, that the World Health Organization (WHO) has granted a second Emergency Use Listing (EUL) for NVX-CoV2373, Novavax’ recombinant protein nanoparticle COVID-19 vaccine with Matrix-M™ adjuvant, for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. Today’s EUL pertains to vaccine to be marketed by Novavax as Nuvaxovid™ COVID-19 Vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted]) in Europe and other markets. NVX-CoV2373 is also being manufactured and marketed in India and licensed territories by Serum Institute of India Pvt. Ltd. (SII), as Covovax™, which was granted EUL on December 17. Nuvaxovid and Covovax are based on the same Novavax recombinant protein technology and the EULs are based on a common pre-clinical, clinical and chemistry, manufacturing and controls (CMC) package. “Today’s Emergency Use Listing underscores the ongoing need and potential for Novavax to help significantly increase COVID-19 vaccine access across the globe through a protein-based option built on a well-understood platform,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We thank the World Health Organization for its thorough assessment and look forward to helping address major obstacles to controlling the pandemic, including practical barriers to access and vaccine hesitancy.”
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