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BumRushDaShow

(129,892 posts)
Fri Oct 1, 2021, 07:25 AM Oct 2021

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 there’s 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 drug’s 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 pill’s 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

52 replies = new reply since forum marked as read
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Merck says a trial shows it has produced the first effective antiviral pill for Covid. (Original Post) BumRushDaShow Oct 2021 OP
That's great news. LisaL Oct 2021 #1
I wonder also, if this will lead to "spin-off" drugs/therapies/treatments... NurseJackie Oct 2021 #3
Why would they spend money to make a drug for a disease for which the whole "disease" 3Hotdogs Oct 2021 #4
I predict that Biden will NOT try to claim "credit after the fact" ... NurseJackie Oct 2021 #2
As I was following the vaccine development efforts over the past year BumRushDaShow Oct 2021 #5
Thank for the information. Think this new age of misinformation mandates a Ministry of Information. Alexander Of Assyria Oct 2021 #6
Welcome to DU ! KS Toronado Oct 2021 #15
"Ministry of Truth"? robbob Oct 2021 #20
Isn't that what the Nazis had? KS Toronado Oct 2021 #21
1984 actually... robbob Oct 2021 #22
Now I see the light, George Orwell, KS Toronado Oct 2021 #38
I confess, I had to look it up... robbob Oct 2021 #43
So I guess we're in the same boat...... KS Toronado Oct 2021 #44
Didnt want to plagiarize 😬 Alexander Of Assyria Oct 2021 #40
It is good news, but people still need to get the vaccine. It cuts deaths by half, so preventive JohnSJ Oct 2021 #7
This would be useful for the "breakthrough" infections BumRushDaShow Oct 2021 #8
Yes, and also the unvaccinated who should have gotten the vaccine. JohnSJ Oct 2021 #16
They are too busy trying to get their "horse pills" from Merck BumRushDaShow Oct 2021 #17
Also, the very limited testing indicates it is 50% effective JohnSJ Oct 2021 #18
I think in this case BumRushDaShow Oct 2021 #27
Agreed. What this may do is ease the hospital load burden JohnSJ Oct 2021 #31
Hopefully BumRushDaShow Oct 2021 #34
Sounds good but bucolic_frolic Oct 2021 #9
You forgot the microchip. nt Chellee Oct 2021 #10
LOL, excellent! KS Toronado Oct 2021 #13
If it is wryter2000 Oct 2021 #12
Don't give the anti-vaxxers any ideas. zanana1 Oct 2021 #52
In Memoriam: For the 8 who died from getting the placebo instead of the real thing Submariner Oct 2021 #11
You realize in clinical trials the patients are fully informed if they choose to take part JohnSJ Oct 2021 #36
This message was self-deleted by its author hamsterjill Oct 2021 #41
So how many congress people have secretly been buying up Merck stock? KS Toronado Oct 2021 #14
Unfortunately.... SergeStorms Oct 2021 #19
That's a really small sample size- most drug trials are in the 10's of thousands. Nt Fiendish Thingy Oct 2021 #23
This is a good development Farmer-Rick Oct 2021 #24
Yeah?...yeah? Well blow it down Silver's throat and griloco Oct 2021 #25
Every time I see news like this, I check out what the RWNJ have to say about it MissMillie Oct 2021 #26
Jinx BumRushDaShow Oct 2021 #30
I do the same thing Sapient Donkey Oct 2021 #50
Good news BUT bluestarone Oct 2021 #28
If is promted as being "approved by Biden" BumRushDaShow Oct 2021 #33
Do as Canada will do by end of this month...Vaccinated? If not, no planes trains and ships for you! Alexander Of Assyria Oct 2021 #42
Think this Rebl2 Oct 2021 #29
As long as it causes severe diarrhea 48656c6c6f20 Oct 2021 #32
You forgot the other potential side effects of the alternate BumRushDaShow Oct 2021 #37
I hear it has to be dissolved in bleach packman Oct 2021 #35
Good news but the drug people refuse to take is 100% ineffective Takket Oct 2021 #39
Merck says there is a chance of "genetic mutations" with molnupiravir. Get vaccinated instead. PSPS Oct 2021 #45
It's not one or the other DrToast Oct 2021 #47
If you're vaccinated, you almost certainly won't get seriously sick. That's the way to go. PSPS Oct 2021 #48
But Ivermectin's cheaper Yo_Mama_Been_Loggin Oct 2021 #46
And Clorox is only pennies per dose! Scrivener7 Oct 2021 #49
I really hope this ends up working and that it doesn't get politicized... VarryOn Oct 2021 #51

LisaL

(44,980 posts)
1. That's great news.
Fri Oct 1, 2021, 07:39 AM
Oct 2021

Because it sure looks like covid is here to stay. Pills are a lot easier to use than infusions.

NurseJackie

(42,862 posts)
3. I wonder also, if this will lead to "spin-off" drugs/therapies/treatments...
Fri Oct 1, 2021, 07:44 AM
Oct 2021

... that could more easily treat the seasonal flu or even the common cold (or other viral infections and diseases).

3Hotdogs

(12,456 posts)
4. Why would they spend money to make a drug for a disease for which the whole "disease"
Fri Oct 1, 2021, 07:48 AM
Oct 2021

is a fraud?
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Yes Agnes, its sarcasm.

NurseJackie

(42,862 posts)
2. I predict that Biden will NOT try to claim "credit after the fact" ...
Fri Oct 1, 2021, 07:42 AM
Oct 2021

... or in any way hint that he should be personally thanked for this drug's development.

BumRushDaShow

(129,892 posts)
5. As I was following the vaccine development efforts over the past year
Fri Oct 1, 2021, 07:50 AM
Oct 2021

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


FOR IMMEDIATE RELEASE
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&J’s vaccine.

Consistent with the Administration’s 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 Administration’s 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&J’s 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&J’s 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&J’s 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 BARDA’s 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.

###



KS Toronado

(17,424 posts)
15. Welcome to DU !
Fri Oct 1, 2021, 08:54 AM
Oct 2021

"Ministry of Information" sounds kinda Fascist, need a more neutral term to fight misinformation. IMHO

JohnSJ

(92,492 posts)
7. It is good news, but people still need to get the vaccine. It cuts deaths by half, so preventive
Fri Oct 1, 2021, 08:07 AM
Oct 2021

is still the better option

BumRushDaShow

(129,892 posts)
8. This would be useful for the "breakthrough" infections
Fri Oct 1, 2021, 08:16 AM
Oct 2021

which for some very vulnerable who are doubly-vaccinated AND boosted, can still be harrowing.

BumRushDaShow

(129,892 posts)
17. They are too busy trying to get their "horse pills" from Merck
Fri Oct 1, 2021, 09:08 AM
Oct 2021

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 -

BumRushDaShow

(129,892 posts)
27. I think in this case
Fri Oct 1, 2021, 09:43 AM
Oct 2021

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.

Coronavirus drug remdesivir to cost $3,120 per patient with private insurance, irking critics

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 Gilead’s 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 Citizen’s 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

BumRushDaShow

(129,892 posts)
34. Hopefully
Fri Oct 1, 2021, 10:14 AM
Oct 2021

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)
9. Sounds good but
Fri Oct 1, 2021, 08:19 AM
Oct 2021

is it really a combo of bleach, dioxychloroquine, UV particles, and ivermectin? How do we know it isn't?

wryter2000

(46,126 posts)
12. If it is
Fri Oct 1, 2021, 08:36 AM
Oct 2021

The covidiots will take it. Otherwise they’ll just continue to abuse medical caregivers until they’re intubated.

zanana1

(6,136 posts)
52. Don't give the anti-vaxxers any ideas.
Sat Oct 2, 2021, 02:20 PM
Oct 2021

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)
11. In Memoriam: For the 8 who died from getting the placebo instead of the real thing
Fri Oct 1, 2021, 08:34 AM
Oct 2021

that was the depressing side of this morning's news story.

JohnSJ

(92,492 posts)
36. You realize in clinical trials the patients are fully informed if they choose to take part
Fri Oct 1, 2021, 10:17 AM
Oct 2021

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)

SergeStorms

(19,204 posts)
19. Unfortunately....
Fri Oct 1, 2021, 09:15 AM
Oct 2021

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.

Farmer-Rick

(10,228 posts)
24. This is a good development
Fri Oct 1, 2021, 09:32 AM
Oct 2021

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)
25. Yeah?...yeah? Well blow it down Silver's throat and
Fri Oct 1, 2021, 09:38 AM
Oct 2021

see if TheLoneRanger can still HI O AWAY to William Tell!!!

MissMillie

(38,599 posts)
26. Every time I see news like this, I check out what the RWNJ have to say about it
Fri Oct 1, 2021, 09:40 AM
Oct 2021

They're not interested. They want their horse de-wormer.

BumRushDaShow

(129,892 posts)
33. If is promted as being "approved by Biden"
Fri Oct 1, 2021, 10:10 AM
Oct 2021

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).

Rebl2

(13,583 posts)
29. Think this
Fri Oct 1, 2021, 09:55 AM
Oct 2021

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. That’s 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)
32. As long as it causes severe diarrhea
Fri Oct 1, 2021, 10:09 AM
Oct 2021

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)
37. You forgot the other potential side effects of the alternate
Fri Oct 1, 2021, 10:18 AM
Oct 2021
seizures, coma, and death.

that truly represent one's true devotion and acceptance of absolute fealty and martyrdom to "own the libs".
 

packman

(16,296 posts)
35. I hear it has to be dissolved in bleach
Fri Oct 1, 2021, 10:14 AM
Oct 2021

and you must stand in front of a strong light for it to be effective

PSPS

(13,628 posts)
45. Merck says there is a chance of "genetic mutations" with molnupiravir. Get vaccinated instead.
Fri Oct 1, 2021, 03:17 PM
Oct 2021

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.

PSPS

(13,628 posts)
48. If you're vaccinated, you almost certainly won't get seriously sick. That's the way to go.
Fri Oct 1, 2021, 04:22 PM
Oct 2021

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.

 

VarryOn

(2,343 posts)
51. I really hope this ends up working and that it doesn't get politicized...
Sat Oct 2, 2021, 12:46 AM
Oct 2021

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.

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