The Dominant Delta Variant and Lambda Variant Lurking in the Shadows

The COVID-19 Delta Variant is hitting the population hard right now, and with vaccine skepticism at an all-time high, the unvaccinated population is at significant risk although we are beginning to see increases in vaccinations in areas hardest hit by the current 4th wave. Complicating matters is the new Lambda variant for which the WHO indicated the new variant carried a number of mutations that could increase transmissibility or increase resistance to neutralizing antibodies produced from the Sinovac-CoronaVac vaccine (China National Pharmaceutical Group) based on a recent preprint. There are many approaches the healthcare industry has and will continue to take to reduce risk and save people from morbidity and mortality; the first is vaccines. ?There are a growing number of cases of immune escape, or breakthrough cases, from the vaccinated population so at issue is our preparedness to combat this threat.

Pfizer, Moderna, and others are preparing booster shots for this delta variant. The SARS-CoV-2 virus will continue to mutate, and vaccine booster shots will be perpetually behind the curve with each new dominant iteration of the virus. Not only does vaccine development lag the emerging virus strains but vaccine hesitancy continues to contribute to a population that is not fully vaccinated, especially if the vaccines will require ongoing, perpetual administration with each new variant. The Biden Administration’s plan to vaccinate 70% of adult Americans by Independence Day fell short, and the pace of vaccinations cannot protect the vulnerable against the Delta for anywhere between 2 and 6 weeks after first inoculation, with 90% taking 6 weeks to be considered fully vaccinated. Dr. Anthony Fauci recently mentioned on CNN that there are certain hotspots in geographical regions where there low vaccination rates, as if there are “two Americas,” where some spots may have blips of high virus transmission.

Even in vaccinated individuals, the risk of sickness and death increases with viral variants. According to new data from Israel, the Pfizer vaccine still protects against death (94%), but this is down from 97% as measured before. This further underscores the importance of other lines of defense against the perpetually mutating SARS-CoV-2, such as antivirals. Antiviral therapeutics that can act regardless of the viral variant and save lives that are at risk of becoming seriously ill, whether vaccinated or unvaccinated, are desperately needed, which is why the Biden Administration recently pivoted away from complete reliance on vaccines with a $3.2 billion funding plan for oral antivirals. These effective oral antivirals are desired to be available as soon as possible, such as within a year.

The Delta Variant is now considered the dominant COVID-19 strain and it is spreading and wreaking havoc across highly populated and less vaccinated geographical areas in the United States.?With the Delta Variant people are getting sicker, and some experts are dubbing the Delta Variant “COVID-19 on steroids.” The bottom line is that the war on COVID-19 isn’t over until vaccination levels create a herd immunity or until there is a very effective antiviral for it. Todos and other pharma companies are developing promising antivirals to protect people from the virus irrespective of their vaccination status or any new strains. There are various biological targets being tested, with the most promising being those that are found to be safe and immutable, as they don’t change as the virus changes.

On the antiviral battlefront, Todos Medical is developing Tollovir?, which is an oral antiviral nearly identical in its mechanism of action to Pfizer’s promising oral antiviral COVID-19 therapeutic.?Each of these drugs go after the same 3CL protease target.?Tollovir has an excellent safety profile and is extremely potent based upon the clinical data that we have gathered. Since the ingredients are derived from natural products, we are required to ensure that they contain the active 3CL protease inhibitor, which is the moiety that the drives rapid reductions in viral loads. Additionally, Tollovir has ingredients that have been identified to have potent anti-cytokine activity and we see the result of this in the clinical data that were gathered in Israel by our joint venture partner NLC Pharma in 2020 observational studies. We intend to share our studies in the weeks ahead as we continue to advance our hospitalized and non-hospitalized clinical development programs. NLC Pharma has been leading the research into the 3CL protease for over 20 years, and we believe this knowledge base has given us a tremendous leg up in terms of understanding how to treat patients, as we monitor the hospitalized patients with our 3CL protease companion biomarker TolloTest?. It is important for people to be prepared to combat the Delta Variant, and Todos Medical is proud to be a part of the fight.