June 9, 2021 6:45 am ET
U.S. government commits to purchase approximately 1.7 million courses of Molnupiravir upon issuance of Emergency Use Authorization or approval by the U.S. Food and Drug Administration
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced it has entered into a procurement agreement with the United States government for molnupiravir (MK-4482). Molnupiravir is currently being evaluated in a Phase 3 clinical trial, the MOVe-OUT study, for the treatment of non-hospitalized patients with laboratory-confirmed COVID-19 and at least one risk factor associated with poor disease outcomes. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics...
Through the agreement, if molnupiravir receives Emergency Use Authorization (EUA) or approval by the U.S. Food and Drug Administration (FDA), Merck will receive approximately $1.2 billion to supply approximately 1.7 million courses of molnupiravir to the United States government. Merck has been investing at risk to support development and scale-up production of molnupiravir and expects to have more than 10 million courses of therapy available by the end of 2021. https://www.merck.com/news/merck-announces-supply-agreement-with-u-s-government-for-molnupiravir-an-investigational-oral-antiviral-candidate-for-treatment-of-mild-to-moderate-covid-19/
KENILWORTH, N.J. & MIAMI--(BUSINESS WIRE)-- October 1, 2021-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19. At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/
On November 4, 2021, the UK proudly announced the approval of molnupiravir:
First oral antiviral for COVID-19, Lagevrio (molnupiravir), approved by MHRA
The antiviral was found to be safe and effective following a stringent review of the available evidence.
NOT MERCKMECTIN
This drug's only association with ivermectin is the fact that both are produced by Merck. Merck's rejection of ivermectin was presented as an argument against ivermectin. Actually, it only served to attract attention to the dishonesty of Pharma.
"Let’s look at how molnupiravir works. To start off, note that molnupiravir (shortened to NHC) IS NOT similar in structure to Ivermectin as many people have claimed.is a nucleoside analogue, the same class of drugs that remdesivir is in, meaning that it is a modified version of the nucleosides utilized in our bodies...
Phase 1 and 2 trials of NHC in mice and ferret models infected with SARS-COV2 showed large improvements, and in human trials there was evidence of no viral load by day 5 of the trial. There were even very few acute toxicities listed.
Although this seems like it could be a wonder drug for SARS-COV2, NHC’s therapeutic capabilities could lead to catastrophic consequences down the road.
Remember that NHC acts as a mutagen and can alter the viral genome. Many nucleoside analogues are broad spectrum therapeutics, meaning that they can affect many cells in your body since our cells are not able to differentiate between the drug and the proper nucleosides.
This side effect is prominent in many cancer patients receiving chemotherapeutics. Many chemotherapeutics are nucleoside analogues, and are administered in an attempt to utilize the rapidly dividing nature of cancer cells, but this also means that many of our rapidly dividing cells can become targets as well. That’s why many of the side effects of chemotherapies include hair loss, dry skin and brittle nails, dry eyes, and GI issues." https://moderndiscontent.substack.com/p/the-possible-side-effect-of-mercks
THE FDA DRUG ADVISORY MOLNUPIRAVIR COMMITTEE MEETING
Molnupiravir was approved in a recorder session. The votes were 13 yes, 10 no. See details of the discussion at https://moderndiscontent.substack.com/p/what-i-learned-watching-the-molnupiravir-630
Molnupiravir
Merck has just applied to the FDA for an emergency use authorization of Molnupiravir for early treatment of COVID-19. Molnupiravir is a mutagenic nucleotide analogue. It increases the rate of mutations in the coronavirus’ RNA and in human DNA.
The application is based on alleged interim results of an unfinished trial, where this drug was given to 385 patients in 173 sites all over the world, and the patients were then observed for 29 days since recruitment and randomization.
Molnupiravir is mutagenic and toxic for human cells. Merck and Ridgeback Biotherapeutics have flatly denied this and proceeded with human trials. The consequences of Molnupiravir’s DNA mutagenesis, such as cancer or birth defects, take months or years to develop. The 24 days of patient observation after 5 days treatment is obviously not enough to detect anything. ..
All Molnupiravir trials were conducted by Merck or its partners. No results have been published in peer reviewed journals. Nevertheless, Dr. Fauci gave it a nod of approval. The US government has already purchased 1.7 million “treatment courses” from Merck, and it is on the course to manufacture and ship 10 million of them by the end of 2021. The relevant parties act as if the EUA approval is just a formality and are proceeding as if it were already granted. https://trialsitenews.com/merck-ignores-molnupiravirs-cytotoxicity/
COVID-19 development
In late July 2020, Merck, which had been partnering with Ridgeback Biotherapeutics on developing the drug, announced its intention to move molnupiravir to late stage trials beginning in September 2020.[13] On October 19, 2020, Merck began a one year Stage 2/3 trial that focused on hospitalized patients.[14]
Merck’s Molnupiravir is a mutagenic nucleotide analogue that introduces errors in the SARS-COV-2 RNA at the time of replication and causes lethal mutations that are lethal to the virus itself.
Any major variant of the coronavirus represents local optimum (in mutations space), maximizing coronavirus’ fitness. One- or two-point mutations cannot accomplish this. A new variant can only rise through the change of the virus-host-conditions systems, or through larger mutations set. Even a moderate increase in the point mutations frequency causes a big increase in the frequency of multi-point mutations and dangerous recombinations. Such events are too rare to be caught in small trials, but inevitable in large populations, and might lead to catastrophic consequences. The authorization and broad use of Molnupiravir is likely to breed very dangerous SARS-COV-2 variants. ..
Molnupiravir does not stop coronavirus replication immediately. Multiple replication cycles take place within each host under Molnupiravir. The unfit genomes are eliminated, and the fitter ones (immune escape, higher infectivity etc.) are preferred. This further increases the chances of a large mutation set increasing the virus’ fitness...
The current SARS-COV-2 Delta strain (worldwide prevalence > 80%) has 24 mutations. It was sequenced in August-September 2020 [4]. This suggests that SARS-COV-2 already mutates and evolves faster than we thought, and the sudden appearance, persistence, and recombination of sets of 5+ point mutations is a big driver of it. Can we really afford to increase the frequency of such events thousands of times?
...Broad use of Molnupiravir would likely cause a catastrophic event, such as the emergence of a super-SARS-COV-2, which would evade existing immunity and have an infection fatality rate (IFR) of over 3%. In such a case, the social and infrastructure collapse would kill many more people than would die from the disease...
Of course, Molnupiravir also causes mutations in human DNA [2] [6], but those consequences (cancer, birth defects etc.) will only present themselves later, and their connection to the drug will be denied. Only one study of Molnupiravir’s side effects had been conducted [7] [8]...
Nevertheless, Dr. Fauci has already promised that the FDA would review Molnupiravir as quickly as possible [9]. Even if the drug had very significant benefits for individual patients, it would not justify such a global risk. Molnupiravir is useless. Even at the advertised 50% effect, it is inferior to Ivermectin. https://trialsitenews.com/is-molnupiravir-a-global-catastrophic-threat/
Other medications as well as prophylactic compounds have had very positive results, without the dangers and the $712 cost of of a course of molnupiravir.
In October 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency(EMA) started a rolling review of molnupiravir.[43]
In November 2021, molnupiravir was approved in the UK by the Medicines and Healthcare products Regulatory Agency(MHRA) for the treatment of established infections of COVID-19. The MHRA issued a conditional marketing authorization applicable in the United Kingdom, and an emergency use authorization for Northern Ireland.[2][1][44][45]
Australia purchased 300,000 courses.[46] In October 2021, the New Zealand pharmaceutical supplier Pharmac purchased 60,000 doses.[47]
Drugs already approved and tested over the course of 40 years exist.
Protocols based on cocktails of approved drugs already exist and have been successfully applied since March 2020, with extremely rare casualties.
The approval of a brand-new drug notwithstanding its mutagenic qualities is evidence that we are facing either corruption or a cult or both. Normally, cults consign foot soldiers to poverty, while wealth is reserved to the leadership spheres.
Molnupiravir was approved for use in the Unites States, in spite of a number of committee members expressing concern over the mutagenic effects