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More Stringent Testing is Needed as Regions Head for More Lockdowns

NEW YORK, Nov. 23, 2020 /PRNewswire/ -- Biotechnology and pharmaceutical companies are now very close to an effective vaccine to fight the current pandemic. Earlier this month, Pfizer and BioNTech SE announced that their vaccine candidate was found to be more than 90% effective in preventing the virus in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. And on Friday, the two companies announced that they will submit a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2. This move will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020. The submission is based on a vaccine efficacy rate of 95%, demonstrated in the Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. Todos Medical Ltd. (OTC: TOMDF), Moderna, Inc. (NASDAQ: MRNA), Abbott Laboratories (NYSE: ABT), ADMA Biologics, Inc. (NASDAQ: ADMA), Vaxart, Inc. (NASDAQ: VXRT)

In the meantime, the second wave of the pandemic is hitting harder. For example, Mayor Bill de Blasio on Friday again warned New York City that it is headed for new restrictions as data showed new cases of infected are still rising. "The restrictions that are coming. I've been very overt in the fact that the governor said an orange zone is coming. By our own projections, based on the state data, that will happen soon after Thanksgiving, probably the first week of December," de Blasio explained. Testing remains and will remain a crucial component in the fight against the pandemic. "If we really wanted to get things under control, frequent testing of almost everybody would be one way to do it and we're, of course, nowhere near that," Marc Lipsitch, a Professor of Epidemiology at the Harvard T.H. Chan School of Public Health, said. "We're doing infrequent testing of almost no one."

Todos Medical Ltd. (OTCQB: TOMDF) announced breaking news last week regarding, "positive in vitro data by its joint venture partner NLC Pharma for the Company's dietary supplement Tollovid™, demonstrating its ability to inhibit the 3CL protease. The 3CL protease is an enzyme that is required for the intracellular replication of coronaviruses. Tollovid received a certificate of free sale from the FDA in August 2020 and is being launched commercially into the US market initially at botanical wellness store The Alchemist's Kitchen™ in New York City.

As part of NLC Pharma's development activities for Tollovid, a joint study was conducted in the laboratory of Professor Dan Farr, Vice President of Research and Development at Tel Aviv University. During the study, the ability to inhibit the activity of enzyme 3CL was examined. The researchers believe the 3CL protease plays a key role in coronavirus activity and is critical to allow for processing of the proteins encoding viral RNA. Inhibition of this activity could stop the ability of coronaviruses to replicate, and thus inhibit their ability to spread in the body. During the study it was shown that Tollovid, which is an extract of a botanical substance, was able to successfully inhibit the 3CL protease activity.

Since the beginning of 2020, over 1,000 patients suffering from diseases caused by circulating coronaviruses in Israel have received various dosing regimens of Tollovid, including both hospitalized and non-hospitalized patients. There has been overwhelmingly positive customer feedback on their experience with the product, including significant positive feedback from physicians.  Based on the results of this market research study conducted in Israel, as well as the pioneering research advanced by Dr. Dorit Arad on the entire coronavirus family of viruses for over the last 20 years, NLC Pharma is preparing to initiate a randomized clinical trial in Israel in December 2020 to evaluate the potential for Tollovid to treat patients suffering from actively circulating coronaviruses.

For information related to Todos Medical's COVID-19 testing capabilities, please visit www.todoscovid19.com

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Moderna, Inc. (NASDAQ: MRNA) announced last week 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%. 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. 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).

Abbott Laboratories (NYSE: ABT) announced on October 12th that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company's AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test for use on the ARCHITECT® and Alinity™ platforms. IgM antibody testing can play an important role in understanding if someone has developed antibodies in response to the virus, indicating a recent or prior infection. "Abbott has developed tests to detect the virus at each stage of infection so doctors and their patients are equipped with knowledge of how they are responding to the virus and progressing through recovery," said Robert B. Ford, president and chief executive officer, Abbott. "Antibody tests will continue to play an important role to better understand the virus, the prevalence of COVID-19 in an area and where a patient may be in their recovery."

ADMA Biologics, Inc. (NASDAQ: ADMA) announced earlier in September the launch of COVID-19 ImmunoRank Neutralization MICRO-ELISA, a proprietary, fully-validated ELISA assay for the detection of SARS-CoV-2 neutralizing antibodies in plasma. ImmunoRank™ was developed in collaboration with Leinco Technologies, Inc. ImmunoRank is intended for use as an aid to identify individuals who produce an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, and specifically for the detection of circulating SARS-CoV-2 neutralizing antibodies in human plasma of all immune globulin classes. ImmunoRank is designed to test up to 90 samples per test kit with 99.8% specificity. The assay procedure takes approximately 80 minutes. An Emergency Use Authorization (EUA) submission is currently being prepared for review and potential approval by the U.S. Food and Drug Administration. We will report on material regulatory and commercial developments as we progress.  ADMA has submitted patents for ImmunoRank in the U.S. and certain foreign markets. Both ADMA and Leinco are named as co-inventors on the patents.

Vaxart, Inc. (NASDAQ: VXRT) a clinical-stage biotechnology company developing oral vaccines that are administered by tablet rather than by injection, announced earlier this month additional results from its Hamster Challenge Study. Significant reduction in lung viral load of 4-5 logs in hamsters that received two oral vaccine doses, as compared to non-vaccinated animals. Potent induction of antibody response, with serum IgG antibody titers above 10,000 in hamsters that received two oral vaccine doses. As previously announced, all hamsters that received two oral doses of Vaxart's COVID-19 vaccine candidate showed no systemic weight loss, a key indicator of protection against COVID-19 in this animal model. By contrast, the unvaccinated animals lost approximately 9% total weight. Additionally, unvaccinated hamsters had over two times (2x) the relative lung weight of orally vaccinated hamsters, a sensitive indicator of serious disease that correlates with the viral load findings.

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