The Fort Worth Press - The New Rational FDA COVID Vaccine Policy is Long Overdue, Says NanoViricides' Dr. Diwan

The new FDA COVID Vaccine Booster Shots policy ^[1] is based on the findings that the groups that benefit from repeat of vaccination (i.e. booster shots) are the groups that are likely to be at risk of severe COVID disease from the virus. These groups include all adults over 65 years of age, and persons over 6 months of age that have one or more co-morbidity factors leading to a disposition towards severe COVID if infected.

The FDA policy notes that the benefit of repeat dosing of vaccine among people with low risk (i.e. healthy adults) is uncertain. As such, the FDA now will require randomized, placebo-controlled clinical trials that produce evidence of effectiveness in this healthy adults group if a vaccine is submitted for licensure to include this group.

In the past, the COVID vaccines were approved for all ages above 6 months. This resulted in CDC recommending the COVID vaccines for everyone. Yet, COVID vaccine uptake rate was only about 25% of the eligible persons in the last few years.

Over years of exposure, the population has built immunity due to multiple infections from ever-changing COVID variants as well as multiple vaccinations. An additional booster dose in such population would only make sense if a clear benefit can be proven.

"Evidence-based decision making about vaccine boosters policy for COVID is a welcome change over broadcast vaccine recommendation for all," commented Anil R. Diwan, Ph.D., President and Executive Chairman of NanoViricides, adding, "This rational and scientific, non-dogmatic approach should go a long way towards restoring public trust in institutions that make decisions that affect peoples' lives."

The new policy brings the US FDA policy to be similar to the vaccination policies adopted in most developed countries. Even so, between 100 million to 200 million Americans are estimated to be eligible for boosters because of the broad definition for co-morbidity factors that put a person at high risk of severe COVID, which include obesity, diabetes, asthma, and even mood disorders.

"We believe that when a highly effective antiviral drug against COVID becomes available, the need for vaccination will decrease substantially," said Dr. Diwan, adding, "Our broad-spectrum antiviral drug NV-387 is poised to become an important solution for multiple viral threats that emerge every season, including Influenzas, Coronaviruses, RSV, MPox, and possibly even Measles!"

About NanoViricides

NanoViricides, Inc. (the "Company") ( www.nanoviricides.com ) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.

Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.

The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.

This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
[email protected]

Public Relations Contact:
[email protected]

^[1] Vinay Prasad, M.D., M.P.H., and Martin A. Makary, M.D., M.P.H. "An Evidence-Based Approach to Covid-19 Vaccination", New England J Med., published May 20, 20

SOURCE: NanoViricides, Inc.

View the original press release on ACCESS Newswire

C.Dean--TFWP