Merck says a trial shows it has produced the first effective antiviral pill for Covid.
Source: New York Times
The drug maker Merck said on Friday that it would seek authorization for the first antiviral pill for Covid after its drug, known as molnupiravir, was shown in a clinical trial to cut the risk of hospitalization or death in half when given to high-risk people early in their infections. The treatment could become the first in a wave of antiviral pill products, which experts say could offer a powerful new tool in efforts to tame the pandemic, as they could reach more people than the antibody treatments that are being widely used in the United States for similar patients.
I think it will translate into many thousands of lives being saved worldwide, where theres less access to monoclonal antibodies, and in this country, too, said Dr. Robert Shafer, an infectious disease specialist and expert on antiviral therapy at Stanford University. Late-stage study results of two other antiviral pills, one developed by Pfizer and the other by Atea Pharmaceuticals and Roche, are expected within the next few months. The Merck drug, which is designed to stop the coronavirus from replicating, is to be taken as four capsules twice a day for five days. Merck said an independent board of experts monitoring its study data had recommended that its trial be stopped early because the drugs benefit to patients had proved so convincing.
The company said that the Food and Drug Administration had agreed with that decision. For the research, the monitors looked at data through early August, when the study had enrolled 775 volunteers in the United States and overseas. For volunteers who received the drug, their risk of being hospitalized or dying fell 50 percent, without any concerning side effects, compared with those who received placebo pills, Merck said in a news release announcing the findings. Seven percent of volunteers in the group that received the drug were hospitalized, and none of them died, compared with a 14 percent rate of hospitalization and death including eight deaths in the group that received the placebo.
The Merck pills efficacy was lower than that of monoclonal antibody treatments, which mimic antibodies that the immune system generates naturally when fighting the virus. Those drugs have been in high demand recently, but they are expensive, are typically given intravenously, and have proved cumbersome and labor-intensive for hospitals and clinics to administer. Studies have shown that they reduce hospitalizations and deaths 70 to 85 percent in similar high-risk Covid patients.
Read more: https://www.nytimes.com/2021/10/01/us/merck-antiviral-pill-covid.html
LisaL
(44,980 posts)Because it sure looks like covid is here to stay. Pills are a lot easier to use than infusions.
NurseJackie
(42,862 posts)... that could more easily treat the seasonal flu or even the common cold (or other viral infections and diseases).
3Hotdogs
(12,456 posts)is a fraud?
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Yes Agnes, its sarcasm.
NurseJackie
(42,862 posts)... or in any way hint that he should be personally thanked for this drug's development.
BumRushDaShow
(129,892 posts)Merck decided to go on and drop their vaccine development and instead opted to go with this anti-viral treatment.
However this past spring, they made an agreement with Biden to assist in manufacturing vaccines through a partnership with Janssen (J&J) since they have a huge vaccine manufacturing complex in NC.
- https://www.hhs.gov/about/news/2021/03/02/biden-administration-announces-historic-manufacturing-collaboration-between-merck-johnson-johnson-expand-production-covid-19-vaccines.html
March 2, 2021
Contact: HHS Press Office
202-690-6343
media@hhs.gov
Biden Administration Announces Historic Manufacturing Collaboration Between Merck and Johnson & Johnson to Expand Production of COVID-19 Vaccines
President Biden Invokes Defense Production Act to Support Measures to Accelerate Vaccine Development
President Biden announced today that his Administration has helped forge a historic manufacturing collaboration between two of the largest U.S. health care and pharmaceutical companies, Merck and Johnson & Johnson (J&J), to expand production of J&s COVID-19 vaccine. The collaboration will increase manufacture of vaccine drug substance, as well as its fill-finish capacity two of the biggest bottlenecks facing J&J in the production of its vaccine.
The U.S. Department of Health and Human Services (HHS) will collaborate with Merck to repurpose some of its existing Merck facilities for rapid large-scale manufacturing of vaccines and therapeutics for use in public health emergencies including the current pandemic. The facilities will be available to private sector partners working with the federal government on the COVID-19 response or to produce Merck products against COVID-19. Janssen Pharmaceuticals, part of Johnson & Johnson, will be the first federal partner to use repurposed Merck facilities to manufacture COVID-19 vaccine. Merck will use two of its facilities to produce drug substance, formulate and fill vials of J&Js vaccine.
Consistent with the Administrations mission to ensure that the United States has sufficient long term sustainable capacity to manufacture vaccines, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will leverage the Defense Production Act to provide an initial investment of $105 million in funding for Merck, at the Administrations request, to convert, upgrade and equip Merck facilities to the standards necessary to safely manufacture the vaccine. The company will address all the necessary qualification and validation activities needed for the facilities to be used for large-scale manufacturing.
To further accelerate production of the J&J vaccine, President Biden also announced he has invoked the Defense Production Act to expedite materials in vaccine production, such as equipment, machinery and supplies like single use bags, and he has directed the Department of Defense (DOD) to provide daily logistical support to strengthen J&Js efforts. With the urging and assistance of the Administration, J&J also will begin operating its manufacturing facilities 24/7 to maximize production output.
These efforts will contribute to J&Js ability to accelerate delivery of their vaccine doses from 100 million doses by the end of June to at or near 100 million doses by the end of May. In the long term, these actions will ultimately double J&Js U.S. capacity to produce drug substance and increase the U.S. capacity for fill-finish.
About HHS, ASPR, and BARDA:
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, BARDA-supported products have achieved 59 FDA approvals, licensures or clearances. For more on BARDAs portfolio for COVID-19 diagnostics, vaccines and treatments and about partnering with BARDA, visit medicalcountermeasures.gov. To learn more about coronavirus, visit cdc.gov/coronavirus.
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Alexander Of Assyria
(7,839 posts)KS Toronado
(17,424 posts)"Ministry of Information" sounds kinda Fascist, need a more neutral term to fight misinformation. IMHO
robbob
(3,539 posts)😉😁
KS Toronado
(17,424 posts)Good thing they were anti-fascist.
robbob
(3,539 posts)But same idea.
KS Toronado
(17,424 posts)thanks for jogging my memory! Getting forgetful in my old age.
robbob
(3,539 posts)Just to be sure.
KS Toronado
(17,424 posts)Alexander Of Assyria
(7,839 posts)JohnSJ
(92,492 posts)is still the better option
BumRushDaShow
(129,892 posts)which for some very vulnerable who are doubly-vaccinated AND boosted, can still be harrowing.
JohnSJ
(92,492 posts)BumRushDaShow
(129,892 posts)And since Merck is applying for an EUA for THIS as a COVID-19 treatment and NOT for Merck's Ivermectin as such, then that is even more reason for the unvaccinated loons to reject THIS in favor of what Merck is refusing to promote as a COVID-19 treatment, because "seeking approval from the Commie Socialist Fascist government" is verboten.
I shouldn't need this -
JohnSJ
(92,492 posts)BumRushDaShow
(129,892 posts)its a cost-benefit type thing. The cost of the infusions / full treatment course for Remdesivir is exorbitant apparently compared to what seems to be suggested for this drug.
By Catherine Thorbecke
June 29, 2020, 9:52 AM
The California-based drugmaker Gilead Sciences announced its pricing plans for remdesivir, an antiviral COVID-19 drug candidate, saying the treatment will cost $520 per dose for U.S. private insurance companies and $390 per dose for the U.S. government. For a majority of people who receive a five-day treatment of the drug using six vials (based on current patterns), the total charged to hospitals for patients with private insurance in the U.S. will be $3,120. For those under U.S. government health programs, the total will be $2,340 per patient.
While there are currently no FDA-approved products to treat or prevent COVID-19, remdesivir is the first antiviral medication to show effectiveness against the novel coronavirus in human clinical trials in limiting hospitalization stays. The costs do not represent out-of-pocket costs with a patient using private insurance. That amount would depend on the type of plan they have.
The watchdog group Public Citizen is calling Gileads pricing of the drug an "offensive display of hubris and disregard for the public" because of what it estimates to be $70 million in estimated taxpayer money used to develop the drug through federal grants and clinical trials. "Allowing Gilead to set the terms during a pandemic represents a colossal failure of leadership by the Trump administration," said Peter Maybarduk, director of Public Citizens Access to Medicines Program.
The pricing for the highly sought-after drugs was explained in an open letter from Daniel O'Day, the chairman and CEO of Gilead Sciences. He wrote, "There is no playbook for how to price a new medicine in a pandemic. O'Day said the company has decided to "price remdesivir well below this value" based on tests that showed remdesivir shortened recovery time by an average of four days.
https://abcnews.go.com/US/covid-19-drug-remdesivir-cost-3120-us-patients/story?id=71509977
JohnSJ
(92,492 posts)BumRushDaShow
(129,892 posts)along with reducing the need to continue to set up "pop up" infusion facilities for those seeking out Remdesivir, where treatment (including wait times, infusion time, and post-infusion observation time) can take hours.
bucolic_frolic
(43,447 posts)is it really a combo of bleach, dioxychloroquine, UV particles, and ivermectin? How do we know it isn't?
Chellee
(2,104 posts)KS Toronado
(17,424 posts)wryter2000
(46,126 posts)The covidiots will take it. Otherwise theyll just continue to abuse medical caregivers until theyre intubated.
zanana1
(6,136 posts)I'm sure they'll come up with some rationale for not taking the pill. (But they'll probably take the pill).
Submariner
(12,513 posts)that was the depressing side of this morning's news story.
JohnSJ
(92,492 posts)this is a double blind study, and they may receive the placebo
It is purely voluntary, and they are given a choice. They don't have to take part in the study
Whether the facility they are at has monoclonal antibodies available or other treatment options that should all factor into their decision if they want to take part in the study
It cut the risk of death by 50% in the limited study
Those that decided to take part in the study, just as those who took part in the vaccine trials took the risk potentially help themselves and others
Response to Submariner (Reply #11)
hamsterjill This message was self-deleted by its author.
KS Toronado
(17,424 posts)SergeStorms
(19,204 posts)we won't be privy to that information for years, if ever. You can bet those who get the most campaign cash from BIG PHARMACEUTICAL COMPANIES were on the short list for that information though.
Fiendish Thingy
(15,696 posts)Farmer-Rick
(10,228 posts)But it must be administered early in the infection and only cuts the death rate/serious side effects by half. But it is a very good start.
I'm glad I didn't sell my Merck stock.
griloco
(832 posts)see if TheLoneRanger can still HI O AWAY to William Tell!!!
MissMillie
(38,599 posts)They're not interested. They want their horse de-wormer.
BumRushDaShow
(129,892 posts)And note the irony of that in the above-linked post
(either way Merck "wins" )
Sapient Donkey
(1,568 posts)I have no idea why I punish myself like that.
bluestarone
(17,102 posts)Just gives some people ANOTHER reason NOT to take the Vaccination i dread!
BumRushDaShow
(129,892 posts)then the loon GOP will "do the opposite" and "reject" it, and it will be used for those who really need it - i.e., those going through breakthrough infections and don't have any or enough private insurance coverage to pay for Remdesivir (once that government contract is done).
Alexander Of Assyria
(7,839 posts)Rebl2
(13,583 posts)will just encourage people to not get vaccinated possibly. You would have to go the doctor to get tested and a prescription. My local news also had information about this and said a person would have to take 4 pills twice a day for 5 days. Thats a lot of pills and I already have to take a lot of pills a day. No thanks. I am vaccinated and hav already had the booster. Much rather take a shot to prevent disease. Will the pills be free like the vaccine-I would doubt it.
48656c6c6f20
(7,638 posts)And can be administered to horses or other farm animals, obtained through dubious means, and will own the libs, and it might be helpful.
BumRushDaShow
(129,892 posts)that truly represent one's true devotion and acceptance of absolute fealty and martyrdom to "own the libs".
packman
(16,296 posts)and you must stand in front of a strong light for it to be effective
Takket
(21,681 posts)Im so frustrated.
PSPS
(13,628 posts)On the NPR piece about this, they said that Merck says there is a chance of "genetic mutations" with molnupiravir. So, while it may be useful as a palliative, it falls far short when comparing it to the vaccines.
DrToast
(6,414 posts)You can still get sick if youre vaccinated.
PSPS
(13,628 posts)I understand what you're saying. I worded my comment the way I did because I presume some unvaccinated people will think that they don't need the vaccine after all if this is around.
Yo_Mama_Been_Loggin
(108,398 posts)Scrivener7
(51,075 posts)VarryOn
(2,343 posts)Like so many things COVID-related. And hopefully, production can get going soon. With winter approaching, it would be nice to have another arrow in the quiver.