Merck have announced that the company is discontinuing development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591.
This decision follows Merck’s review of findings from Phase 1 clinical studies for the vaccines. In these studies, both V590 and V591 were generally well tolerated, but the immune responses were inferior to those seen following natural infection and those reported for other SARS-CoV-2/COVID-19 vaccines.
Merck continues to advance clinical programs and to scale-up manufacturing for two investigational medicines, MK-7110 and MK-4482 (molnupiravir); molnupiravir is being developed in collaboration with Ridgeback Bio. The drugs aim to protect patients from the damage of an overactive immune response to the virus.
They state “We are grateful to our collaborators who worked with us on these vaccine candidates and to the volunteers in the trials,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “We are resolute in our commitment to contribute to the global effort to relieve the burden of this pandemic on patients, health care systems and communities.”
Merck and its collaborators plan to submit the results of the Phase 1 studies for V590 and V591 for publication in a peer-reviewed journal. In addition to advancing the development and production of MK-7110 and MK-4482, Merck will continue to conduct SARS-CoV-2/COVID-19 research.
About Merck’s therapeutic candidates
- MK-7110 (formerly CD24Fc) is an investigational recombinant fusion protein that modulates the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint. Interim results from a Phase 3 study showed a greater than 50% reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Full results from this study are expected in the first quarter of 2021.
In December, Merck announced a supply agreement with the U.S. government to advance the manufacturing and initial distribution of MK-7110 (link).
- Molnupiravir (MK-4482) is an oral novel investigational antiviral agent being developed in collaboration with Ridgeback Bio. Molnupiravir is currently being evaluated in Phase 2/3 clinical trials in both the hospital and out-patient settings. The primary completion date for the Phase 2/3 studies is May 2021. The company anticipates initial efficacy data in the first quarter of 2021, which Merck plans to share publicly if clinically meaningful.
Safety controversy
In April 2020, a whistleblower complaint by former Head of US Biomedical Advanced Research and Development Authority (BARDA) Rick Bright revealed concerns over providing funding for the further development of molnupiravir due to similar drugs having mutagenic properties (producing birth defects). A previous company, Pharmasset, that had investigated the drug’s active ingredient had abandoned it. These claims were denied by George Painter, CEO of DRIVE, noting that toxicity studies on molnupiravir had been carried out and data provided to regulators in the US and UK, who permitted safety studies in humans to move forward in the spring of 2020. Also at this time, DRIVE and Ridgeback Biotherapeutics stated they planned future safety studies in animals. https://en.wikipedia.org/wiki/Molnupiravir
Analysis
My only thought – it is refreshing to see natural immune responses being brought back into the fray. Unfortunately during the “Covid-era” we have seen natural immunity being suppressed and sullied – and cross reactive memory T-cells ignored completely.
On a personal level I will once again be choosing natural immunity over synthetic as I have historically.
https://www.clinicaltrials.gov/ct2/show/NCT04317040
https://unitynewsnetwork.co.uk/new-study-shows-potential-of-t-cells-in-the-fight-against-covid-19/
https://pubmed.ncbi.nlm.nih.gov/33024281/
I wrote my first article for Unity News Network on 30th December 2019, and I have been writing ever since – my library is now well in excess of 200 articles.
Alternative media is essential in these times of unprecedented censorship and mainstream bias, which has ramped up exponentially during the past 2 years. The overton window of “acceptable opinion” is growing every narrower.
Having a citizen’s log, cataloguing the twists and turns of life during these turbulent times is essential.
Thank you Unity News Network for allowing me a voice on your platform.
