Coronavirus:

[chuck]

The results have not been peer reviewed by outside experts, the usual procedure for vetting new medical research.

Why not?

An independent group of medical experts monitoring the trial recommended stopping it early because the interim results were so strong.

Since when?

That is typical when early results show so clearly that a treatment works that there is no need for further testing before applying for authorization.

WTF?

Once the submission is complete, the FDA could make a decision within weeks — and, if OK’d, the drug could be on the market soon after. Merck only studied its drug in people who were not vaccinated. But FDA regulators may consider authorizing it for broader use in vaccinated patients who get COVID-19 symptoms.

You have people screaming about the testing procedures for the vaccines. The main shortcut was that all of the clinical trials were run simultaneously instead of the "typical" sequential series. At least they did run the full battery of tests and then the full analysis. If you can't trust the vaccine why would you trust a drug that has bypassed ALL of the normal, rigorous, detailed testing procedures?

Replication inhibitor that was abandoned by one company due to mutagen concerns

This one might lead to some really, really, really nasty side effects!

[Neil]

I’m sure the FDA specialist reviewers will take all the data into account when making a decision. Very few drugs that are taken for five days have any genetic effects.

[HONDO74]

Another article about the pill... from the BBC

Covid antiviral pill can halve risk of hospitalisation
https://www.bbc.com/news/health-58764440

An experimental drug for severe Covid cuts the risk of hospitalisation or death by about half, interim clinical trial results suggest.

The tablet - molnupiravir - was given twice a day to patients recently diagnosed with the disease.

US drug-maker Merck said its results were so positive that outside monitors had asked to stop the trial early.

It said it would apply for emergency use authorisation for the drug in the US in the next two weeks.

Dr Anthony Fauci, chief medical adviser to US President Joe Biden, said the results were "very good news", but urged caution until the US Food and Drug Administration (FDA) had reviewed the data.

If authorised by regulators, molnupiravir would be the first oral antiviral medication for Covid-19.

The pill, which was originally developed to treat influenza, is designed to introduce errors into the genetic code of the virus, preventing it from spreading in the body.

An analysis of 775 patients in the study found:

7.3% of those given molnupiravir were hospitalised
that compares with 14.1% of patients who were given a placebo or dummy pill
there were no deaths in the molnupiravir group, but eight patients who were given a placebo in the trial later died of Covid

The data was published in a press release and has not yet been peer-reviewed.

Unlike most Covid vaccines, which target the spike protein on the outside of the virus, the treatment works by targeting an enzyme the virus uses to make copies of itself.

Merck, known by the name MSD in the UK, said that should make it equally effective against new variants of the virus as it evolves in the future.

Daria Hazuda, Merck's vice-president of infectious disease discovery, told the BBC: "An antiviral treatment for people who are not vaccinated, or who are less responsive to immunity from vaccines, is a very important tool in helping to end this pandemic."

[Rufus T. Firefly]

The results have not been peer reviewed by outside experts, the usual procedure for vetting new medical research.

Why not?

There's no requirement to publish your data and clinical trials in peer reviewed journals -- never has been. It will get reviewed when they submit their data to the FDA

An independent group of medical experts monitoring the trial recommended stopping it early because the interim results were so strong.

Since when?

Happens routinely when results are compelling and justify doing so. Always has been the case; nothing new about that.

That is typical when early results show so clearly that a treatment works that there is no need for further testing before applying for authorization.

WTF?

Again, this happens routinely when results are compelling and justify doing so. Always has been the case; nothing new about that. Particularly so when the control arm has death in it and the treatment arm does not. Pretty much a no-brainer decision on survival vs. death.

Once the submission is complete, the FDA could make a decision within weeks — and, if OK’d, the drug could be on the market soon after. Merck only studied its drug in people who were not vaccinated. But FDA regulators may consider authorizing it for broader use in vaccinated patients who get COVID-19 symptoms.

You have people screaming about the testing procedures for the vaccines. The main shortcut was that all of the clinical trials were run simultaneously instead of the "typical" sequential series. At least they did run the full battery of tests and then the full analysis. If you can't trust the vaccine why would you trust a drug that has bypassed ALL of the normal, rigorous, detailed testing procedures?

Who says it has not been run through the usual testing procedures? They did an FDA approved phase 2/3 trial and the pre-clinical testing as well that was down well in advance.

Replication inhibitor that was abandoned by one company due to mutagen concerns

This one might lead to some really, really, really nasty side effects!

So might having covid.......and as with nearly all drugs, they are a balancing act of probabilities - not a y/n engineering equation.

[Rufus T. Firefly]

Unlike most Covid vaccines, which target the spike protein on the outside of the virus, the treatment works by targeting an enzyme the virus uses to make copies of itself.

That author apparently does not understand how vaccines work And, it doesn't target an enzyme either.....but rather introduces errors in the replication process by being an error causing mimic resulting in the virus to fail in that action. One of the fairly standard anti-viral strategies.

And, this is not a cure per se, but a treatment.....that small detail seems to be getting lost in the S/N. You still have covid....it's just kept under a level of control that your body can handle.......better......

[robert.]

Unlike most Covid vaccines, which target the spike protein on the outside of the virus, the treatment works by targeting an enzyme the virus uses to make copies of itself.

And, this is not a cure per se, but a treatment.....that small detail seems to be getting lost in the S/N. You still have covid....it's just kept under a level of control that your body can handle.......better......

Sounds like the same as the vaccine. Only reduces hospitalization and death

[Rufus T. Firefly]

Unlike most Covid vaccines, which target the spike protein on the outside of the virus, the treatment works by targeting an enzyme the virus uses to make copies of itself.

And, this is not a cure per se, but a treatment.....that small detail seems to be getting lost in the S/N. You still have covid....it's just kept under a level of control that your body can handle.......better......

Sounds like the same as the vaccine. Only reduces hospitalization and death

Then you've been misinformed and/or do not understand the difference between a vaccine and a therapeutic.

[robert.]

You’re killing me with semantics.

[Neil]

The vaccines are the primary tool to mitigate coronavirus illness and death. The oral anti-viral(s) will be to treat breakthrough infections, infections in those too misinformed, fragile, stupid, ornery, ignorant or ideologically insane to be vaccinated, and to use for prophylaxis in those exposed but not yet ill. Pretty much the way we try to deal with influenza but with more effective vaccines at this point. So the two approaches complement each other. The monoclonal antibodies will be used in those who do not respond to the vaccines, or have sub-optimal responses. One more tool to stop people from getting seriously ill or dying.

[HONDO74]

The New York Times
Is the Coronavirus Getting Better at Airborne Transmission?
https://news.yahoo.com/coronavirus-gett ... 48597.html

Newer variants of the coronavirus such as alpha and delta are highly contagious, infecting far more people than the original virus. Two new studies offer a possible explanation: The virus is evolving to spread more efficiently through air.

The realization that the coronavirus is airborne indoors transformed efforts to contain the pandemic last year, igniting fiery debates about masks, social distancing and ventilation in public spaces.

Most researchers now agree that the coronavirus is mostly transmitted through large droplets that quickly sink to the floor and through much smaller ones, called aerosols, that can float over longer distances indoors and settle directly into the lungs, where the virus is most harmful.

Munster’s team showed that small aerosols traveled much longer distances than larger droplets and the alpha variant was much more likely to cause new infections via aerosol transmission. The second study found that people infected with alpha exhaled about 43 times more virus into tiny aerosols than those infected with older variants.

The studies compared the alpha variant with the original virus or other older variants. But the results may also explain why the delta variant is so contagious — and why it displaced all other versions of the virus.

“It really indicates that the virus is evolving to become more efficient at transmitting through the air,” said Linsey Marr, an expert in airborne viruses at Virginia Tech who was not involved in either study. “I wouldn’t be surprised if, with delta, that factor were even higher.”

[HONDO74]

So it wasn't a bat virus it was a lobster virus according to China.

Chinese media says Maine lobster shipment was 'Pandora's box' behind pandemic
https://news.yahoo.com/chinese-media-sa ... 00450.html

Hannah LaClaire, Portland Press Herald, Maine
Sat, October 2, 2021, 4:59 AM

Oct. 2—A shipment of Maine lobster has been identified by Chinese media as a likely culprit for the start of the coronavirus pandemic, a claim a Maine official called "nonsensical."

A recent article in the Sina news portal, one of the most read on China's state-controlled internet, reported that in mid-November 2019, a batch of seafood from Maine was shipped to the "Wuhan South China Seafood Market," also known as the Huanan Seafood Market, where the virus was first reported in late 2019.

According to the translated Sina article, within a few weeks, employees in the market began experiencing "symptoms of pneumonia of unknown origin one after another."

Sina named "the Seashell Company" in York County as the original source of the lobster. The Seashell Company does not exist, but a map in the article identifies the company's headquarters as those of York-based lobster exporter Maine Coast Shellfish.

The article suggests that a shipment of 55 boxes of chilled lobster arrived at the Shanghai Pudong Airport on Nov. 11, 2019, and was then distributed to 26 customers across the country, including an unnamed vendor at the Huanan Seafood Market.

"I am afraid it was this batch of American lobsters that opened the Pandora's box of the epidemic," the article said.

[Rufus T. Firefly]

So it wasn't a bat virus it was a lobster virus according to China.

[MurphOnMillerAve]

Has he aged well? (I can't decide.)

[Rufus T. Firefly]

Has he aged well? (I can't decide.)

If you can't decide then I think that's a yes,

BTW, good to see you posting here, Murph

[gregj410]

Dr Ouchy says no Christmas gatherings this year kids!
Merry Christmas

https://youtu.be/dw2zpe5Pock