Zyesami is Safe and with Declining Vaccine Efficacy We are Going to Need ItWith
Israeli data showing reduced vaccine efficacy that starts to accelerate after 6 months, the U.S. is scrambling to get ready to give its citizens booster shots earlier than anticipated. U.S. agencies are preparing to offer booster shots to all eligible Americans beginning the week of Sept. 20. In Australia that’s when adults will be lining up for their first vaccine shot.
With over 1,000 deaths a day again in America, things are getting serious for hospitalizations rise, even among children. The vaccines aren’t looking that great over time.
NRx Pharmaceuticals released rather empty PR that we already knew today, that Zyesami is safe, in an NIH sponsored report that tracked 140 patients in ACTIV-3 critical care study, where no new safety concerns were raised by independent data safety monitoring board. Relief ticker $RLFTF (OTC) and ticker $NRXP await an EUA for this promising lung saving treatment that could reduce Delta variant mortality rates where Delta is seen with a higher viral load as slightly more dangerous.
This is also because as the pandemic drags on ICU Nurses and hospital staff are getting PTSD and having to leave the profession at scale meaning in 2022 some hospital systems will be more likely to crash. Deaths have mounted in recent days in Russia, Indonesia, Iran, Brazil, South Africa – I mean all across the world as even mRNA vaccinated people can transmit the Delta variant, and reduced efficacy of the double vaccinated after 6 months means a significant rise in hospitalizations among them who are 65+, as Isarel has shown.
Zyesami could be one of the best treatments globally for Covid-19 in 2022 and 2023, especially if Delta mutates to become more dangerous (as is perhaps 15% likely).
So to repeat Zyesami that is being tested in the ACTIV-3 Critical Care Phase 3 study sponsored by the National Institutes of Health. The study’s Data Safety Monitoring Board found no new safety concerns in the trial and recommended continued enrollment. From Relief Therapeutics we already knew Zyesami was perfectly safe so it’s puzzling why the PR news stoked a short-lived 30% rally in the stock of $NRXP that like $OCGN has a meme-rally army of watchers.
The true beneficiary of all of this is however Relief, a small biotech company in Switzerland ticker $RLFTF. They have the majority of global rights and half of the North American profits on the Zyesami patent. The partnership between the two firms has been fraught with challenges and added expenses due to conflicts. Needless to say NRx Pharmaceuticals wouldn’t be fighting if Zyesami was nothing.
Relief has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (“FDA”) for RLF-100 (aviptadil), an inhaled formulation in development for the treatment of sarcoidosis. RLF-100 is a synthetic form of vasoactive intestinal peptide. In open label exploratory clinical experience in sarcoidosis patients, RLF-100 has been shown to be well tolerated and safe, and to produce favorable immunoregulatory effects in the lungs that have been associated with symptom relief in a significant proportion of the patients. The commercial name is Zyesami.
Orphan Drug Designation is granted for products that are intended to treat life-threatening or chronically debilitating conditions affecting less than 200,000 patients in the U.S. and no more than five in 10,000 persons in the European Union.
One of the major problems for Delta in 2022 in the U.S. is both its impact on children and that around 10% of cases become long-Covid a debilitating condition that requires disability benefits for months and in some cases permanently. With the high transmission and lax masking guidelines by the CDC, the situation is more dire in the U.S. than it appears. Cases of Children being hospitalized has gone up around 300% in just a few weeks. The U.S. will likely reach some kind of herd blunting effect of Delta sometime in September, 2021 (like the UK) where cases go down suddenly, not to be mistaken with herd immunity which is now very unlikely for the Delta variant since breakthrough cases are so common due to higher viral loads.
This all suggests a treatment for serious hospitalizations like Zyesami becomes more valuable at scale, globally. As vaccines are no longer the silver bullet, treatments become more important. $NRXP as a stock is very volatile going from $10 to $30 and wildly moving like a meme stock. However, based on future earnings potential ticker $RLFTF is a much more serious long-term winner since the stock is only at a price point of around $0.21.
All of this suggests that Zyesami once seen as a dark horse potential treatment is getting more mainstream acceptance. ZYESAMI™ is administered as a daily 12 hour intravenous infusion over three days, typically in the ICU or as a preventative measure. This is all because ZYESAMI™ (aviptadil) is a proprietary, synthetic version of Vasoactive Intestinal Peptide or VIP, which is made naturally in the human body and appears to have lung-protective, anti-viral and anti-inflammatory effects.
Herd immunity is impossible
Breakthrough cases are common
Children and Long-Covid complicate the Delta situation in 2022
Booster shots are needed 6 months after 2nd dose
New treatments will arrive for ICU cases such as Zyesami
The Israel data really do show a bleak forward indicator for America’s Covid-19 situation. The Delta variant and what it might mutate into really is being underestimated by an economic recovery that’s begging for the virus to go away, rather than being careful with moderate State guidance. The U.S. appears very content to let Delta sweep the country yet again, leading to a needless loss of life even as other countries take more strict lockdown and mass testing measures. Canada is ahead in terms of both vaccination rates and vaccination passport systems. China employs mass testing while Australia are doing full-on lockdowns. America seems more concerned with its economy and the financial impact of policies than solid health measures and safety precautions.
In Israel after 6 months vaccine efficacy against hospitalizations is drastically reduced and this is frankly a nightmare scenario for global control of the pandemic. This makes an EUA for Zyesami in the next few weeks or months much more likely, as the FDA has no choice but to take a closer look at newer treatments, as vaccines aren’t everything and herd immunity is not within sight.https://lastfuturist.com/zyesami-is-safe-and-with-declining-vaccine-efficacy-we-are-going-to-need-it/
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