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COVID Testing Back in High Demand Due to Omicron

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The pandemic is back at full force as the number of infected with the new Omicron variant is breaking records. As a result of the new wave, testing kits are in short supply.

New York City, which is now once again the epicenter of the pandemic in the U.S., has recorded nearly 50,000 new cases on December 24 alone. This is the highest single-day total in the state since the pandemic started.

Similarly to 2020, the nationwide spike in cases has been harmful to the economy due to restrictions, which have affected sports events, shipping and especially travel, with thousands of flights canceled throughout the holiday weekend. Globally, airlines canceled more than 6,000 flights on Christmas Eve, Christmas and the day after Christmas, according to FlightAware. Todos Medical Ltd., Pfizer Inc., Moderna, Inc., Inovio Pharmaceuticals, Inc., Merck & Co., Inc.

According to Anthony S. Fauci, chief medical adviser to President Biden, it is going to be very important, “that we get a greater capability of testing, particularly when the demand for testing is so high, with the combination of the Omicron variant itself, as well as the holiday season, where people want to get that extra level of assuredness that they’re protected, even if you are vaccinated and boosted.”

Todos Medical Ltd. announced yesterday that, “its highly automated CLIA/CAP PCR and cPass neutralizing antibody COVID-19 testing laboratory Provista Diagnostics achieved consecutive record weekly COVID PCR testing volumes for the weeks of December 13, 2021 and December 20, 2021. The COVID PCR testing volumes were primarily driven by reference lab business from a New York-based PCR testing lab that could not fulfill the testing demand from its location. The Company also entered into a new laboratory services agreement with a New Jersey-based physician practice for COVID PCR Testing and COVID cPass neutralizing antibody testing.

‘The demand for PCR testing is rapidly increasing in pockets of the United States, and we expect this to continue beyond the holiday surge as individuals, schools and employers seek to create safe environments, especially in areas with low vaccination rates,’ said Gerald E. Commissiong, President & CEO of Todos Medical, the parent company of Provista Diagnostics. ‘Given the pending ‘vaccine or test’ mandate from the Biden Administration that will impose testing requirements on the 38% of the US adult population that have yet to be fully vaccinated against COVID-19, we see the recent scarcity of testing combined with the pending mandate creating demand for a very significant increase in long-term institutional COVID PCR testing for Provista. When you add the Omicron variant’s ability to evade vaccine or infection-acquired immunity, and the challenges of access and reliability of rapid antigen tests that notoriously yield false negative results, COVID PCR testing with fast turnaround times is emerging as the most trusted and reliable source of information to know one’s COVID infection status.’

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Mr. Commissiong continued, ‘Further, when you combine these realities with a recent uptick in interest in boosters to buttress vaccine or infection-acquired immunity against Omicron, we are beginning to see a marked increase in interest for the cPass neutralizing antibody test to monitor levels of circulating neutralizing antibody testing and allow patients to make rapid, data-driven decisions to get their booster shots, especially given emerging data that suggests high neutralizing antibody-titers produced from a recent booster shot is the most likely to protect an individual against Omicron infection.’

Recent data emerging from Israel suggests neutralizing antibody titers in response to the Pfizer/BioNTech Comirnaty vaccine begins to wane after 4 months from full-vaccination, and that booster shots of Comirnaty begin to wane after 10 weeks from the booster shot. A fourth shot (the “Second Booster”) was recently authorized in Israel for the immune-compromised and those 60+, and a study is underway to determine the durability of a Second Booster for the general population.

Pfizer Inc. announced last week that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. The treatment includes nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer’s laboratories, which was specifically designed to block the activity of the SARS-CoV-2 Mpro, an enzyme that the coronavirus needs to replicate. “Today’s authorization of PAXLOVID represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world. This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Pfizer stands ready to begin delivery in the U.S. immediately to help get PAXLOVID into the hands of appropriate patients as quickly as possible.”

Moderna, Inc. announced on December 20, 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.”

Inovio Pharmaceuticals, Inc.  announced last month updates on the Phase 3 program for VGX-3100 for HPV-associated cervical high-grade squamous intraepithelial lesions (HSIL), including a one-year follow-up of efficacy and safety data in participants from REVEAL1, completing enrollment in REVEAL2, and advancing its pre-treatment biomarker candidate for VGX-3100 to be further developed with QIAGEN. In addition, INOVIO’s development partner within Greater China (mainland China, Hong Kong, Macao, Taiwan), ApolloBio Corp. (“ApolloBio”), dosed the first participant in a separate Phase 3 trial in China. Dr. J. Joseph Kim, President and CEO of INOVIO, said, “We are making strong progress in developing INOVIO’s immunotherapies treating HPV-associated cervical HSIL. Left untreated, cervical HSIL may progress to cancer. VGX-3100 has the potential to be the first approved immunotherapy and non-surgical alternative for women with cervical HSIL and we look forward to advancing our efforts from our Phase 3 studies through commercialization.”

Merck & Co., Inc. announced earlier this month that 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.

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About the author

editor

Editor in chief for eTurboNew is Linda Hohnholz. She is based in the eTN HQ in Honolulu, Hawaii.

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