Much Touted Merck’s COVID-19 Drug-Molnupiravir Shown To Be Less Effective In New Analysis. Experts Question Its Efficacy Against The Omicron Variant
: Updated data on molnupiravir shows the drug reduces hospitalization or death by 30%, down from the initially reported 50% efficacy.
Last week Merck has provided updated data on its COVID-19 antiviral, molnupiravir, that shows the antiviral to be significantly less effective against the virus than previously thought. https://www.merck.com/news/merck-and-ridgeback-biotherapeutics-provide-update-on-results-from-move-out-study-of-molnupiravir-an-investigational-oral-antiviral-medicine-in-at-risk-adults-with-mild-to-moderate-covid-19/
The new analysis, shared by the company shows that treatment with molnupiravir reduces hospitalization or death by 30%. The drug’s efficacy is considerably lower than what was reported in interim analysis in October, when molnupiravir was said to reduce the risk of hospitalization and death by around 50%.
The new updated results are based on an analysis of data from all 1,433 enrolled patients in the MOVe-OUT study of the drug. Merck said both the interim analysis and additional data “support the efficacy and overall favorable benefit-risk assessment” of molnupiravir as a treatment for mild-to-moderate COVID-19 in those at high risk of severe disease.
The new data was further scrutinized at a US FDA Advisory committee meeting being held to discuss molnupiravir’s potential emergency use authorization.
A panel of expert advisers to the U.S. Food and Drug Administration on Tuesday narrowly voted to recommend the agency authorize Merck & Co's (MRK.N) antiviral pill to treat COVID-19.
"COVID-19 is still an emergency situation," said committee member Dr. David Hardy, who voted yes. "There is a need for something like this. This is the first opportunity that an oral outpatient medication for mildly symptomatic to moderately symptomatic persons would be available, although I do have questions about its overall longer-term efficacy."
The Phase II/III results were planned for publication in the New England Journal of Medicine but have been delayed because of new information, the journal said.
Molnupiravir has been touted as a potential game-changer in the fight against Covid-19 ever since the interim data showing drastic reductions in hospitalization and death were released. Initial enthusiasm for the drug led to its approval by the UK’s medicines regulator in early November, and purchase agreements for large supplies of the drug have been made with a number of countries.
To date there are no real COVID-19 Drugs
that have proven to be effective in treating the COVID-19 disease. Most approved under EUA status by the U.S. FDA are basically overpriced drugs with questionable true efficacy and in some cases some have proven to be toxic while some are seemingly driving mutations and variants as in the case of the monoclonal and polyclonal therapeutics.
mp;rsquo;s updated results for molnupiravir come just days after a new SARS-Cov-2 variant, Omicron (B.1.1.529), was detected in South Africa. The variant has since been identified in several other countries including Australia, the UK and Canada and has been classified as a variant of concern by the World Health Organization (WHO). It is not yet clear how the mutations in the new variant affects the virus’s transmissibility, severity of disease or the effectiveness of currently available vaccines and treatments, as per the WHO.
A pharma expert speaking on conditions of anonymity warned, "If you look at the sequence of the of the RNA polymerase, the sequence of the Omicron variant is slightly different from all of these other variants, so how can you predict that it should be equally active?"
There are also concerns that the molnupiravir being a mutagenic drug might actually drive more worrisome SARS-CoV-2 mutations and variants.
The new Omicron variant’s emergence has also put the spotlight on Pfizer’s antiviral, Paxlovid, which is also vying for an emergency use authorization based on an 89% efficacy in reducing COVID-19-associated hospitalization or death. Pfizer is also yet to publish results from its own Paxlovid trial but has signed several delivery agreements already.
Thailand Medical News predicts that both drugs are just typical COVID-19 drug scams being perpetrated by big pharma and also the American and European politicians and the billionaire techies controlling the COVID-19 narratives as in the case of the drug Remdesivir.
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