Covid-19: Treatments, Cures, and Vaccines

The US study also didn't show a mortality benefit. A closer look at the study shows the greatest efficacy, trending very close to statistical significance, in COVID patients who are sick enough to require oxygen but not sick enough to require anything more.

In other words, you should not demand Remdesivir as soon as you're diagnosed because even the POTUS did not get it as soon as he's diagnosed. He received it after his oxygen levels dipped, but before he got any worse, which is exactly when the American study demonstrated the best efficacy.

 

It is an anti-viral drug. The earlier it is deployed, the better. That does not seem to be in dispute with people who know far more than I do, including the folks at Gilead themselves. The question is how late in the course of the disease does efficacy wain.....

 

I think Gilead may be a tad more biased than a practicing physician like me. The issue with using medications when there's minimal/no effect is that all drugs have side effects, and when the efficacy is small, side effects outweigh the efficacy.

Take Remdesivir for example, a high proportion of patients get liver damage. I've had to stop it in quite a few patients due to rapidly worsening liver function tests. It can also cause kidney damage, though generally it happens in people with existing kidney disease so we don't offer it to them (significant kidney disease is considered a contraindication for Remdesivir usage).

For any medication there is also the risk of allergic reaction, including deadly ones like anaphylaxis and TEN.

This is why your doctor (if you have a good one, that is) won't give you Z-pack for a runny nose. There is always the potential for harm with any medication, and when efficacy is none, then all you're left with is the potential for harm.

 

I have read that some percentage of people are having/developing liver problems.

I guess the confusing part is the assertion that the "efficacy is none". in the interest of discussion, I will assume that what you are saying (as a doctor) is true and has been observed around the world by other doctors and that this drug is has "minimal/ no effect" in treating this disease. I (not an expert or doctor) am then left to guess that what the people at Gilead are saying is more marketing that actual science, though I had thought I had read otherwise. It would not be the first drug over marketed by the manufacturer.

The WHO study has not been reviewed, and we have seen numerous publications pulled or dramatically altered after put on Medrxiv.org. However, if the WHO study is ultimately shown to be conclusive and the quality of the data good, then it would seem that the marketing machine is more effective than I would have guessed. Definitely something to inquire about.

Thanks for the corrections.

 

Gilead’s Covid-19 Drug Is Mediocre. It Will Be a Blockbuster Anyway.
Gilead Sciences said Wednesday that remdesivir, which has been authorized for emergency use since the spring, brought in $873 million in revenues so far this year.

“This is a troubling approval,” said Dr. Peter B. Bach, the director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center. “This is an extremely weak set of trials to support an approval for an antiviral.”

Remdesivir was seen as one of the brightest hopes in the dark days of March and April, when doctors had few tools to treat a new disease and families rushed to gain access to the drug in a desperate gambit to save their dying relatives.

More than six months later, enthusiasm has fizzled. One large, government-run trial showed that the drug shortens patients’ recovery times, but the two other studies the F.D.A. used to justify its approval — sponsored by Gilead — did not compare the treatments with a placebo, the gold standard for evaluating a drug. No studies have shown that it significantly lowers death rates.
And just days before the F.D.A. granted approval, a large study sponsored by the World Health Organization found that remdesivir provided no benefit to hospitalized patients.
.............

Remdesivir isn't looking all that great to me.

 

Like all things COVID, $$$$$$$.

 

Cui bono?

 

This is the same anti-body cocktail that was given to President Trump. Worth noting that the Trial has been halted only for the study of patients requiring high flow oxygen or mechanical ventilation. The studies of the other groups continue.

Regeneron hit by 'safety signal' for COVID-19 cocktail as data board tells pharma to stop enrolling sicker patients

 

Astra Zeneca hopeful to deliver interim data on its vaccine candidate Phase 3 trial in 2020 and sees a small chance that they could have regulatory approval to have it available in the UK by the end of December.

Trial chief tips AstraZeneca COVID-19 vaccine for 2020 data drop

 

On June 29, 2020, it was announced that the United States Department of Health and Human Services (HHS) had agreed to buy 500,000 remdesivir treatment courses. Gilead was quoted in the announcement, in a section mentioning that each five-day course of remdesivir—for treatment of a patient with coronavirus—would cost at least US$2,340.00.

 

News that has the stock market excited. Pfizer has provided no detailed data, so, this is mostly just a headline, but they are claiming that their 2-shot vaccine candidate is 90% effective.

Covid-19 vaccine from Pfizer and BioNTech is strongly effective, data show

 

Well that will certainly be a game changer if true.

 

Thank you for keeping this thread current

 

Just wish I understood more about the details of what I was read and regurgitating, but it has been an educating 9 months for a Physics guy to follow along.

Thanks.

 

What you’re not fluent in RNA messenger vaccines like the rest of us

Hopefully not another false ad campaign. Pfizer allegedly sunk 2B in development and did not join operation WS. Huge profit potential here, not to mention the obvious public health impact

Edited to add it looks like Pfizer signed a deal a while back to provide 100 million doses (??) for 2B. Allegedly will be free to US citizens (tax dollars)

 

Just leaving this here for those who assume Operation Warp Speed did a damn thing for what we are seeing.

 

PFE Pfizer and BioNTech (BNTX) announce vaccine candidate against COVID-19 achieved success in first interim analysis from Phase 3 study (36.40 )

• The cos announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.
• After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at seven days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continues to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.
• Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate -- the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization -- will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose. Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced. Based on supply projections, we expect to supply globally up to 50 million vaccine doses in 2020 and manufacture up to 1.3 billion doses in 2021. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.

Read more: Briefing.com: Hourly In Play (R)

 

Fauci/CDC said 50-60% effective would be sufficient, 90% would be amazing.

Interestingly while the Dow Futures are way up on Pfizer and a spike in 10yr t-yield, Nasdaq futures are slightly down.

 

I think that most of the "heavy lifting" in terms of basic research was done by their German partner, BioNTech. Pfizer was alone to provide manufacturing scale and, oh yeah, claim the lion's share of any profits.

For us though, if I recall correctly, the Pfizer candidate targets receptor binding domain on the spike protein, where as the Modern vaccine candidate targets the spike protein more broadly (my simple terms...not actual terms). So, I suppose that it is hoped that Pfizer candidate is that effective, Moderna's can also show such efficacy.

 

Statement from the President-Elect.